American Ginseng in Treating Patients With Fatigue Caused by Cancer

• Sponsor: Alliance for Clinical Trials in Oncology (Other)
• Overall Status: Completed
• CT.gov ID: NCT00719563
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 364
• Locations: 326
• Arms: 2
• Duration (Months): 58
• Patients Per Site: 1.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: American ginseng may reduce fatigue in patients with cancer. It is not yet known whether American ginseng is more effective than a placebo in treating cancer-related fatigue.

PURPOSE: This randomized phase III trial is studying American ginseng to see how well it works in treating patients with fatigue caused by cancer.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloproliferative Disorders; Fatigue; Leukemia; Lymphoma; Lymphoproliferative Disorder; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Precancerous Condition; Unspecified Adult Solid Tumor, Protocol Specific	Drug: American ginseng; Other: placebo	Phase 3

Detailed Description

OBJECTIVES:

Primary

• To evaluate the efficacy of American ginseng (Panax quinquefolius) as therapy for cancer-related fatigue as measured by the general subscale of the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF).

Secondary

• To evaluate toxicities and tolerability of American ginseng when used for cancer-related fatigue.

• To examine stress as a mediating variable on the effects of American ginseng on cancer-related fatigue.

• To explore the impact of American ginseng on various dimensions of fatigue as measured by the other subscales of the MFSI-SF, functional interference as measured by the Brief Fatigue Inventory (BFI), stress as measured by the Perceived Stress Scale, and well being as measured by the Profile of Mood States (POMS), as well as the single measure of fatigue.

• To determine clinically significant changes in fatigue scores using the global impression of change.

• To evaluate whether there are differences in the efficacy of American ginseng for fatigue based on minority populations.

Tertiary

• To describe cortisol and cytokine values in fatigued cancer survivors and to evaluate the relationship of cortisol and cytokines to fatigue severity as well as to patterns of alterations previously documented in fatigued breast cancer survivors.

• To evaluate whether Wisconsin Ginseng impacts the expression of cortisol and cytokine in fatigued cancer survivors.

• To evaluate the role of cortisol and cytokine changes as the mechanism by which Wisconsin Ginseng can ameliorate cancer related fatigue.

• To evaluate the relationships between cytokine and cortisol levels with secondary outcomes such as mood and stress.

OUTLINE: This is a multicenter study. Patients are stratified according to baseline fatigue score (4-7 vs 8-10), disease status of current cancer (initial diagnosis vs recurrent disease), current treatment (chemotherapy, radiation, endocrine therapy [i.e., tamoxifen or aromatase inhibitors], or other targeted therapy) ( yes vs no), duration of all prior cancer treatment in patient's lifetime (none vs ≤ 180 days vs > 180 days), and current tumor type (hematologic vs solid tumor malignancy). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral American ginseng twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses until disease progression or unacceptable toxicity.

• Arm II: Patients receive oral placebo twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses.

Patients are instructed to complete the Ginseng Symptom Experience Diary and the Linear Analogue Scale weekly. Patients also complete the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), the Profile of Mood States (POMS), and the Brief Fatigue Inventory (BFI) questionnaires at baseline and periodically during study therapy.

Patients who are not actively receiving chemotherapy or radiation therapy undergo blood and saliva sample collection at baseline and periodically during study therapy for correlative studies.

Study Design

• Study Type: Interventional
• Actual Enrollment: 364 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: The Use of American Ginseng (Panax Quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Placebo-Controlled Phase III Study
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Patients receive oral American ginseng twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses.	Drug: American ginseng; Given orally
Placebo Comparator: Arm II Patients receive oral placebo twice daily for 14 days. Treatment repeats every 2 weeks for 4 courses.	Other: placebo; Given orally

Outcome Measures

Primary Outcome Measures

1. Change From Baseline to Week 4 in the General Subscale of the MFSI-SF [Baseline and week 4]

   Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling "pooped, worn out, fatigued, sluggish, run down and tired". Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.

Secondary Outcome Measures

1. Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence [Week 1 to Week 8]

   Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.

2. Change From Baseline to Week 4 in the Impact on Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF [Baseline and Week 4]

   Each MFSI-SF subscale consist of 6 items on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were then converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.

3. Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue [Baseline and Week 4]

   Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.

4. Change From Baseline to Week 4 Vigor/Activity and Fatigue-inertia as Measured by POMS [Baseline and Week 4]

   Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The scores were then transformed into a 100-point scale with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.

5. Change From Baseline to Week 4 for the Impact on Stress as Measured by Perceived Stress Scale (PSS) [Baseline and Week 4]

   PSS consist of 14 items that assess the impact on stress in a 5-points scale (0=never, 1=almost never, 2=sometimes, 3=fairly often and 4=very often). The total scores were the sum of all 14 items. The scores were then transformed into a 100-point scale with higher numbers indication less stress. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.

6. Change From Baseline to Week 8 in the Impact on General, Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF [Baseline and week 8]

   Each MFSI-SF subscale consist of 6 items on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were then converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.

7. Change From Baseline to Week 8 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue [Baseline and Week 8]

   Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.

8. Change From Baseline to Week 8 Vigor/Activity and Fatigue-inertia as Measured by POMS [Baseline and week 8]

   Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The scores were then transformed into a 100-point scale with higher numbers indicating less fatigue. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.

9. Change From Baseline to Week 8 for the Impact on Stress as Measured by Perceived Stress Scale (PSS) [Baseline and Week 8]

   PSS consist of 14 items that assess the impact on stress in a 5-points scale (0=never, 1=almost never, 2=sometimes, 3=fairly often and 4=very often). The total scores were the sum of all 14 items. The scores were then transformed into a 100-point scale with higher numbers indication less stress. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.

10. Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3 [Baseline and Week 4]

    Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale (LASA) fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).

11. Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3 [Baseline and Week 8]

    Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).

12. Change From Baseline to Week 4 in the General Subscale of the MFSI-SF for Minority Populations [Baseline and Week 4]

    Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling "pooped, worn out, fatigued, sluggish, run down and tired". Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

1. Required characteristics

• ≥ 18 years of age

• Men or women with a history of cancer-related fatigue as defined by an average score ≥ 4 over the past 30 days on the numeric analogue scale (1 - 10)

• The presence of fatigue ≥ 1 month prior to randomization

• ECOG performance score 0, 1, or 2

• Histologic or cytologic proven cancer other than brain cancer or CNS lymphoma, undergoing curative intent therapy (including anti-hormonal therapies such as tamoxifen or leuprolide) or those having completed curative intent therapy who were diagnosed within the past 2 years

• Note: If a patient is receiving treatment for their disease such as chemotherapy, targeted therapies, immunotherapy or radiation therapy then, the patient must have completed ≥ 1 cycle of chemotherapy, targeted therapy, or ≥ 1 week of radiation treatment.

• Laboratory values obtained prior to randomization:

• Hgb ≥ 11 (must be obtained ≤ 30 days; patients must not be transfused ≤ 30 days to meet this criterion)

• Creatinine ≤ 1.2 x UNL (must be obtained ≤ 180 days prior to randomization)

• AST (SGOT) or ALT (SGPT) ≤ 1.5 x UNL (must be obtained ≤ 180 days prior to randomization)

• Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only

• Ability to complete patient questionnaires alone or with assistance

• Controlled:

• Pain (≤ 4 on Linear Analogue Scale)

• Insomnia (≤ 4 on Linear Analogue Scale)

• Willingness to provide blood/saliva samples for correlative studies.

• Note: These samples are only required for those not receiving active treatment for their disease. Active treatment is defined as chemotherapy, radiation therapy, or immunotherapy, not anti-hormone therapy such as tamoxifen, aromatase inhibitors or leuprolide.

1. Contraindications

• Hypersensitivity to ginseng

• Prior use of ginseng capsules for fatigue in the past year

• Note: Prior use of teas or drinks containing ginseng is allowed, however, patients will be asked to avoid these beverages while on the study.

• Uncontrolled hypertension on more than one occasion (diastolic blood pressure > 100, systolic > 160) measured ≤ 90 days prior to randomization

• Currently using any other pharmacologic agents or nonpharmacologic interventions to specifically treat fatigue including psychostimulants, antidepressants, acupuncture, etc.

• Note: Antidepressants used to treat items other than fatigue (such as hot flashes) are allowed if the patient has been on a stable dose for ≥ 1 month and plans to continue for ≥ 1 month. Erythropoietin agents to treat anemia are allowed. Exercise is allowed.

• Known brain metastasis or primary CNS malignancy

• Chronic systemic steroid use (including CHOP therapy or as part of any regular cancer treatment, however, steroids used as prophylaxis for nausea and vomiting are allowed) to prevent rash with Alimta, low dose dexamethasone will be allowed.

• Diabetes Type I or II (defined by being on oral hypoglycemics or insulin).

• Psychiatric disorder such as severe depression, manic depressive disorder, obsessive compulsive disorder or schizophrenia. (Defined per medical history).

• ≤ 4 weeks from major surgery to randomization, including any procedure that requires general anesthetic

• Any of the following:

• Pregnant women

• Nursing women

• Women of childbearing potential who are unwilling to employ adequate contraception

• Pain requiring opioid pain medication, however, over the counter analgesics such as Tylenol or ibuprofen are allowed.

• Use of full dose of anticoagulant therapy (Exception: 1 mg/day of Coumadin for preventing catheter clots is allowed).

• Use of MAO inhibitors.

• Planning to start or complete any type of cancer therapy during the 8 week, double blind, course of the study, once randomized on the study. Note: If not currently getting treatment, no chemotherapy agents ≤ 21 days prior to randomization. Combination treatment regimens that have components ending at different times are allowed, as long as any part of the initially started treatment continues through the double blind portion of the study.

• Malnutrition, active infection, significant pulmonary disease and cardiovascular disease as determined by the physician, as they could impact fatigue.

• Use of any over the counter herbal/dietary supplement marketed for fatigue or energy (for example, products containing any type of ginseng, rhodiola rosea, high doses of caffeine, guarana, or anything called an "adaptogen").

• Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily oral ginseng/placebo treatment.

• Uncontrolled thyroid disorder.

• Currently receiving single agent on blinded placebo controlled treatment trials.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Scottsdale	Scottsdale	Arizona	United States	85259-5499
2	Aurora Presbyterian Hospital	Aurora	Colorado	United States	80012
3	Boulder Community Hospital	Boulder	Colorado	United States	80301-9019
4	Penrose Cancer Center at Penrose Hospital	Colorado Springs	Colorado	United States	80933
5	St. Anthony Central Hospital	Denver	Colorado	United States	80204
6	Porter Adventist Hospital	Denver	Colorado	United States	80210
7	Presbyterian - St. Luke's Medical Center	Denver	Colorado	United States	80218
8	St. Joseph Hospital	Denver	Colorado	United States	80218
9	Rose Medical Center	Denver	Colorado	United States	80220
10	CCOP - Colorado Cancer Research Program	Denver	Colorado	United States	80224-2522
11	Swedish Medical Center	Englewood	Colorado	United States	80110
12	Poudre Valley Hospital	Fort Collins	Colorado	United States	80524
13	Front Range Cancer Specialists	Fort Collins	Colorado	United States	80528
14	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado	United States	81502
15	Sky Ridge Medical Center	Lone Tree	Colorado	United States	80124
16	Hope Cancer Care Center at Longmont United Hospital	Longmont	Colorado	United States	80501
17	St. Mary - Corwin Regional Medical Center	Pueblo	Colorado	United States	81004
18	North Suburban Medical Center	Thornton	Colorado	United States	80229
19	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut	United States	06105
20	University of Florida Shands Cancer Center	Gainesville	Florida	United States	32610-0232
21	Mayo Clinic - Jacksonville	Jacksonville	Florida	United States	32224
22	MBCCOP - Medical College of Georgia Cancer Center	Augusta	Georgia	United States	30912
23	Kapiolani Medical Center at Pali Momi	Aiea	Hawaii	United States	96701
24	Cancer Research Center of Hawaii	Honolulu	Hawaii	United States	96813
25	MBCCOP - Hawaii	Honolulu	Hawaii	United States	96813
26	OnCare Hawaii, Incorporated - Lusitana	Honolulu	Hawaii	United States	96813
27	Queen's Cancer Institute at Queen's Medical Center	Honolulu	Hawaii	United States	96813
28	Straub Clinic and Hospital, Incorporated	Honolulu	Hawaii	United States	96813
29	Hawaii Medical Center - East	Honolulu	Hawaii	United States	96817
30	OnCare Hawaii, Incorporated - Kuakini	Honolulu	Hawaii	United States	96817
31	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	United States	96826
32	Tripler Army Medical Center	Honolulu	Hawaii	United States	96859
33	Kauai Medical Clinic	Lihue	Hawaii	United States	96766
34	Maui Memorial Medical Center	Wailuku	Hawaii	United States	96793
35	Pacific Cancer Institute - Maui	Wailuku	Hawaii	United States	96793
36	Rush-Copley Cancer Care Center	Aurora	Illinois	United States	60504
37	Illinois CancerCare - Bloomington	Bloomington%	Illinois	United States	61701
38	St. Joseph Medical Center	Bloomington	Illinois	United States	61701
39	Graham Hospital	Canton	Illinois	United States	61520
40	Illinois CancerCare - Canton	Canton	Illinois	United States	61520
41	Illinois CancerCare - Carthage	Carthage	Illinois	United States	62321
42	Memorial Hospital	Carthage	Illinois	United States	62321
43	Eureka Community Hospital	Eureka	Illinois	United States	61530
44	Illinois CancerCare - Eureka	Eureka	Illinois	United States	61530
45	Galesburg Clinic, PC	Galesburg	Illinois	United States	61401
46	Galesburg Cottage Hospital	Galesburg	Illinois	United States	61401
47	Illinois CancerCare - Galesburg	Galesburg	Illinois	United States	61401
48	Illinois CancerCare - Havana	Havana	Illinois	United States	62644
49	Mason District Hospital	Havana	Illinois	United States	62644
50	Illinois CancerCare - Kewanee Clinic	Kewanee	Illinois	United States	61443
51	Illinois CancerCare - Macomb	Macomb	Illinois	United States	61455
52	McDonough District Hospital	Macomb	Illinois	United States	61455
53	Trinity Cancer Center at Trinity Medical Center - 7th Street Campus	Moline	Illinois	United States	61265
54		Moline	Illinois	United States	61265
55	Illinois CancerCare - Monmouth	Monmouth	Illinois	United States	61462
56	OSF Holy Family Medical Center	Monmouth	Illinois	United States	61462
57	BroMenn Regional Medical Center	Normal	Illinois	United States	61761
58	Community Cancer Center	Normal	Illinois	United States	61761
59	Illinois CancerCare - Community Cancer Center	Normal	Illinois	United States	61761
60	Community Hospital of Ottawa	Ottawa	Illinois	United States	61350
61	Oncology Hematology Associates of Central Illinois, PC - Ottawa	Ottawa	Illinois	United States	61350
62	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois	United States	61554
63	Illinois CancerCare - Pekin	Pekin	Illinois	United States	61603
64	Proctor Hospital	Peoria	Illinois	United States	61614
65	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61615
66	Oncology Hematology Associates of Central Illinois, PC - Peoria	Peoria	Illinois	United States	61615
67	Methodist Medical Center of Illinois	Peoria	Illinois	United States	61636
68	OSF St. Francis Medical Center	Peoria	Illinois	United States	61637
69	Illinois CancerCare - Peru	Peru	Illinois	United States	61354
70	Illinois Valley Community Hospital	Peru	Illinois	United States	61354
71	Illinois CancerCare - Princeton	Princeton	Illinois	United States	61356
72	Perry Memorial Hospital	Princeton	Illinois	United States	61356
73	Illinois CancerCare - Spring Valley	Spring Valley	Illinois	United States	61362
74	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
75	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana	United States	46107
76	Elkhart Clinic, LLC	Elkhart	Indiana	United States	46514-2098
77	Michiana Hematology-Oncology, PC - Elkhart	Elkhart	Indiana	United States	46514
78	Elkhart General Hospital	Elkhart	Indiana	United States	46515
79	Howard Community Hospital	Kokomo	Indiana	United States	46904
80	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana	United States	46350
81	Michiana Hematology-Oncology, PC - South Bend	Mishawaka	Indiana	United States	46545-1470
82	Saint Joseph Regional Medical Center	Mishawaka	Indiana	United States	46545-1470
83	Michiana Hematology Oncology PC - Plymouth	Plymouth	Indiana	United States	46563
84	Reid Hospital & Health Care Services	Richmond	Indiana	United States	47374
85	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
86	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
87	South Bend Clinic	South Bend	Indiana	United States	46617
88	Michiana Hematology Oncology PC - La Porte	Westville	Indiana	United States	46391
89	McFarland Clinic, PC	Ames	Iowa	United States	50010
90		Bettendorf	Iowa	United States	52722
91	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa	United States	52403
92	Mercy Regional Cancer Center at Mercy Medical Center	Cedar Rapids	Iowa	United States	52403
93	Medical Oncology and Hematology Associates - West Des Moines	Clive	Iowa	United States	50325
94	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309
95	John Stoddard Cancer Center at Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
96	Medical Oncology and Hematology Associates at John Stoddard Cancer Center	Des Moines	Iowa	United States	50309
97	Medical Oncology and Hematology Associates at Mercy Cancer Center	Des Moines	Iowa	United States	50314
98	Mercy Cancer Center at Mercy Medical Center - Des Moines	Des Moines	Iowa	United States	50314
99	John Stoddard Cancer Center at Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316
100	McCreery Cancer Center at Ottumwa Regional	Ottumwa	Iowa	United States	52501
101	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa	United States	51101
102	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51104
103	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
104	Hospital District Sixth of Harper County	Anthony	Kansas	United States	67003
105	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas	United States	66720
106	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
107	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas	United States	67042
108	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas	United States	66701
109	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
110	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas	United States	67068
111	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
112	Cancer Center of Kansas, PA - Liberal	Liberal	Kansas	United States	67905
113	Cancer Center of Kansas, PA - Newton	Newton	Kansas	United States	67114
114	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas	United States	67357
115	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas	United States	67124
116	Cancer Center of Kansas, PA - Salina	Salina	Kansas	United States	67401
117	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas	United States	67152
118	Associates in Womens Health, PA - North Review	Wichita	Kansas	United States	67208
119	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas	United States	67208
120	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas	United States	67214
121	CCOP - Wichita	Wichita	Kansas	United States	67214
122	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
123	Wesley Medical Center	Wichita	Kansas	United States	67214
124	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas	United States	67156
125	Ochsner Health Center - Bluebonnet	Baton Rouge	Louisiana	United States	70809
126	Ochsner Health Center - Covington	Covington	Louisiana	United States	70433
127	CCOP - Ochsner	New Orleans	Louisiana	United States	70121
128	Ochsner Cancer Institute at Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
129	Hickman Cancer Center at Bixby Medical Center	Adrian	Michigan	United States	49221
130	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
131	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
132	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan	United States	49017
133	Mecosta County Medical Center	Big Rapids	Michigan	United States	49307
134	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
135	Green Bay Oncology, Limited - Escanaba	Escanaba	Michigan	United States	49431
136	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
137	Hurley Medical Center	Flint	Michigan	United States	48503
138	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan	United States	49503
139	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
140	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan	United States	49503
141	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
142	Dickinson County Healthcare System	Iron Mountain	Michigan	United States	49801
143	Foote Memorial Hospital	Jackson	Michigan	United States	49201
144	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
145	St. Mary Mercy Hospital	Livonia	Michigan	United States	48154
146	Community Cancer Center of Monroe	Monroe	Michigan	United States	48162
147	Mercy Memorial Hospital - Monroe	Monroe	Michigan	United States	48162
148	Mercy General Health Partners	Muskegon	Michigan	United States	49443
149	Michiana Hematology Oncology PC - Niles	Niles	Michigan	United States	49120
150	St. Joseph Mercy Oakland	Pontiac	Michigan	United States	48341-2985
151	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
152	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
153	Lakeside Cancer Specialists, PLLC	Saint Joseph	Michigan	United States	49085
154	Lakeland Regional Cancer Care Center - St. Joseph	St. Joseph	Michigan	United States	49085
155	Munson Medical Center	Traverse City	Michigan	United States	49684
156	St. John Macomb Hospital	Warren	Michigan	United States	48093
157	Metro Health Hospital	Wyoming	Michigan	United States	49519
158		Alexandria	Minnesota	United States	56308
159	MeritCare Bemidji	Bemidji	Minnesota	United States	56601
160	St. Joseph's Medical Center	Brainerd	Minnesota	United States	56401
161	Fairview Ridges Hospital	Burnsville	Minnesota	United States	55337
162	Mercy and Unity Cancer Center at Mercy Hospital	Coon Rapids	Minnesota	United States	55433
163	Duluth Clinic Cancer Center - Duluth	Duluth	Minnesota	United States	55805-1983
164	CCOP - Duluth	Duluth	Minnesota	United States	55805
165	Miller - Dwan Medical Center	Duluth	Minnesota	United States	55805
166	Fairview Southdale Hospital	Edina	Minnesota	United States	55435
167	Fergus Falls Medical Group, PA	Fergus Falls	Minnesota	United States	56537
168	Mercy and Unity Cancer Center at Unity Hospital	Fridley	Minnesota	United States	55432
169	Hutchinson Area Health Care	Hutchinson	Minnesota	United States	55350
170	Immanuel St. Joseph's	Mankato	Minnesota	United States	56002
171	HealthEast Cancer Care at St. John's Hospital	Maplewood	Minnesota	United States	55109
172	Minnesota Oncology Hematology, PA - Maplewood	Maplewood	Minnesota	United States	55109
173	Virginia Piper Cancer Institute at Abbott - Northwestern Hospital	Minneapolis	Minnesota	United States	55407
174	Hennepin County Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55415
175	Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center	Robbinsdale	Minnesota	United States	55422-2900
176	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
177	CentraCare Clinic - River Campus	Saint Cloud	Minnesota	United States	56303
178	Coborn Cancer Center	Saint Cloud	Minnesota	United States	56303
179	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
180	Park Nicollet Cancer Center	Saint Louis Park	Minnesota	United States	55416
181	United Hospital	Saint Paul	Minnesota	United States	55102
182	St. Francis Cancer Center at St. Francis Medical Center	Shakopee	Minnesota	United States	55379
183	Regions Hospital Cancer Care Center	St. Paul	Minnesota	United States	55101
184	Lakeview Hospital	Stillwater	Minnesota	United States	55082
185	Ridgeview Medical Center	Waconia	Minnesota	United States	55387
186	Willmar Cancer Center at Rice Memorial Hospital	Willmar	Minnesota	United States	56201
187	Minnesota Oncology Hematology, PA - Woodbury	Woodbury	Minnesota	United States	55125
188	Goldschmidt Cancer Center	Jefferson City	Missouri	United States	65109
189	Missouri Baptist Cancer Center	Saint Louis	Missouri	United States	63131
190	Comprehensive Cancer Care, PC	Saint Louis	Missouri	United States	63141
191	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65802
192	St. John's Regional Health Center	Springfield	Missouri	United States	65804
193	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
194	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
195	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
196	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
197	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59102
198	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
199	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
200	St. James Healthcare Cancer Care	Butte	Montana	United States	59701
201	Big Sky Oncology	Great Falls	Montana	United States	59405-5309
202	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
203	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
204	Northern Montana Hospital	Havre	Montana	United States	59501
205	St. Peter's Hospital	Helena	Montana	United States	59601
206	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
207	Kalispell Medical Oncology at KRMC	Kalispell	Montana	United States	59901
208	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
209	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
210	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
211	Cancer Resource Center - Lincoln	Lincoln	Nebraska	United States	68510
212	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
213	Immanuel Medical Center	Omaha	Nebraska	United States	68122
214	Alegant Health Cancer Center at Bergan Mercy Medical Center	Omaha	Nebraska	United States	68124
215	Creighton University Medical Center	Omaha	Nebraska	United States	68131-2197
216	Lovelace Medical Center - Downtown	Albuquerque	New Mexico	United States	87102
217	Hematology Oncology Associates, PC	Albuquerque	New Mexico	United States	87106
218	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87131-5636
219	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
220	Bismarck Cancer Center	Bismarck	North Dakota	United States	58501
221	Medcenter One Hospital Cancer Care Center	Bismarck	North Dakota	United States	58501
222	Mid Dakota Clinic, PC	Bismarck	North Dakota	United States	58501
223	St. Alexius Medical Center Cancer Center	Bismarck	North Dakota	United States	58502
224	CCOP - MeritCare Hospital	Fargo	North Dakota	United States	58122
225	MeritCare Broadway	Fargo	North Dakota	United States	58122
226	Altru Cancer Center at Altru Hospital	Grand Forks	North Dakota	United States	58201
227	Mary Rutan Hospital	Bellefontaine	Ohio	United States	43311
228	Wood County Oncology Center	Bowling Green	Ohio	United States	43402
229	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
230	North Coast Cancer Care - Clyde	Clyde	Ohio	United States	43410
231	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
232	CCOP - Columbus	Columbus	Ohio	United States	43215
233	Grant Medical Center Cancer Care	Columbus	Ohio	United States	43215
234	Mount Carmel Health - West Hospital	Columbus	Ohio	United States	43222
235	Doctors Hospital at Ohio Health	Columbus	Ohio	United States	43228
236	Grandview Hospital	Dayton	Ohio	United States	45405
237	Good Samaritan Hospital	Dayton	Ohio	United States	45406
238	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio	United States	45409
239	Samaritan North Cancer Care Center	Dayton	Ohio	United States	45415
240	CCOP - Dayton	Dayton	Ohio	United States	45420
241	Grady Memorial Hospital	Delaware	Ohio	United States	43015
242	Community Cancer Center	Elyria	Ohio	United States	44035
243	Hematology Oncology Center	Elyria	Ohio	United States	44035
244	Blanchard Valley Medical Associates	Findlay	Ohio	United States	45840
245	Middletown Regional Hospital	Franklin	Ohio	United States	45005-1066
246	Wayne Hospital	Greenville	Ohio	United States	45331
247	Charles F. Kettering Memorial Hospital	Kettering	Ohio	United States	45429
248	Fairfield Medical Center	Lancaster	Ohio	United States	43130
249	Lima Memorial Hospital	Lima	Ohio	United States	45804
250	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio	United States	45750
251	Northwest Ohio Oncology Center	Maumee	Ohio	United States	43537-1839
252	St. Luke's Hospital	Maumee	Ohio	United States	43537
253	Knox Community Hospital	Mount Vernon	Ohio	United States	43050
254	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio	United States	43055
255	Fisher-Titus Medical Center	Norwalk	Ohio	United States	44857
256	St. Charles Mercy Hospital	Oregon	Ohio	United States	43616
257	Toledo Clinic - Oregon	Oregon	Ohio	United States	43616
258	North Coast Cancer Care, Incorporated	Sandusky	Ohio	United States	44870
259	Community Hospital of Springfield and Clark County	Springfield	Ohio	United States	45505
260	Flower Hospital Cancer Center	Sylvania	Ohio	United States	43560
261	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
262	Toledo Hospital	Toledo	Ohio	United States	43606
263	St. Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
264	Medical University of Ohio Cancer Center	Toledo	Ohio	United States	43614
265	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43617
266	St. Anne Mercy Hospital	Toledo	Ohio	United States	43623
267	Toledo Clinic, Incorporated - Main Clinic	Toledo	Ohio	United States	43623
268	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio	United States	45373-1300
269	Fulton County Health Center	Wauseon	Ohio	United States	43567
270	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio	United States	43081
271	Clinton Memorial Hospital	Wilmington	Ohio	United States	45177
272	United States Air Force Medical Center - Wright-Patterson	Wright-Patterson Afb	Ohio	United States	45433-5529
273	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio	United States	45385
274	Genesis - Good Samaritan Hospital	Zanesville	Ohio	United States	43701
275	Natalie Warren Bryant Cancer Center at St. Francis Hospital	Tulsa	Oklahoma	United States	74136
276	Clackamas Radiation Oncology Center	Clackamas	Oregon	United States	97015
277	Providence Milwaukie Hospital	Milwaukie	Oregon	United States	97222
278	Providence Newberg Medical Center	Newberg	Oregon	United States	97132
279	Willamette Falls Hospital	Oregon City	Oregon	United States	97045
280	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon	United States	97213-2967
281	Adventist Medical Center	Portland	Oregon	United States	97216
282	CCOP - Columbia River Oncology Program	Portland	Oregon	United States	97225
283	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
284	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania	United States	18105
285	Geisinger Cancer Institute at Geisinger Health	Danville	Pennsylvania	United States	17822-0001
286	Geisinger Hazleton Cancer Center	Hazleton	Pennsylvania	United States	18201
287	Geisinger Medical Group - Scenery Park	State College	Pennsylvania	United States	16801
288	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania	United States	18711
289	AnMed Cancer Center	Anderson	South Carolina	United States	29621
290	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
291	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
292	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57701
293	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
294	Fredericksburg Oncology, Incorporated	Fredericksburg	Virginia	United States	22401
295	St. Joseph Cancer Center	Bellingham	Washington	United States	98225
296	Cascade Cancer Center at Evergreen Hospital Medical Center	Kirkland	Washington	United States	98033
297	Valley Medical Center	Renton	Washington	United States	98055
298	CCOP - Virginia Mason Research Center	Seattle	Washington	United States	98101
299	Pacific Medical Center	Seattle	Washington	United States	98104
300	Southwest Washington Medical Center Cancer Center	Vancouver	Washington	United States	98668
301	Edwards Comprehensive Cancer Center at Cabell Huntington Hospital	Huntington	West Virginia	United States	25701
302	Marshfield Clinic - Chippewa Center	Chippewa Falls	Wisconsin	United States	54729
303	Marshfield Clinic Cancer Care at Regional Cancer Center	Eau Claire	Wisconsin	United States	54701
304	Luther Midlelfort Hospital	Eau Claire	Wisconsin	United States	54702
305	Midelfort Clinic - Luther	Eau Claire	Wisconsin	United States	54703-1510
306	Central Wisconsin Cancer Program at Agnesian HealthCare	Fond du Lac	Wisconsin	United States	54935
307	Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54301-3526
308	Green Bay Oncology, Limited at St. Mary's Hospital	Green Bay	Wisconsin	United States	54303
309	St. Mary's Hospital Medical Center - Green Bay	Green Bay	Wisconsin	United States	54303
310	St. Vincent Hospital Regional Cancer Center	Green Bay	Wisconsin	United States	54307-3508
311	Franciscan Skemp Healthcare - La Crosse Campus	La Crosse	Wisconsin	United States	54601
312	Holy Family Memorial Medical Center Cancer Care Center	Manitowoc	Wisconsin	United States	54221-1450
313	Bay Area Cancer Care Center at Bay Area Medical Center	Marinette	Wisconsin	United States	54143
314	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin	United States	54449
315	Marshfield Clinic - Lakeland Center	Minocqua	Wisconsin	United States	54548
316	Green Bay Oncology, Limited - Oconto Falls	Oconto Falls	Wisconsin	United States	54154
317	Ministry Medical Group at Saint Mary's Hospital	Rhinelander	Wisconsin	United States	54501
318	Marshfield Clinic - Indianhead Center	Rice Lake	Wisconsin	United States	54868
319	St. Nicholas Hospital	Sheboygan	Wisconsin	United States	53081
320	Marshfield Clinic at Saint Michael's Hospital	Stevens Point	Wisconsin	United States	54481
321	Door County Cancer Center at Door County Memorial Hospital	Sturgeon Bay	Wisconsin	United States	54235-1495
322	Green Bay Oncology, Limited - Sturgeon Bay	Sturgeon Bay	Wisconsin	United States	54235
323	Marshfield Clinic - Weston Center	Weston	Wisconsin	United States	54476
324	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin	United States	54494
325	Rocky Mountain Oncology	Casper	Wyoming	United States	82609
326	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• Alliance for Clinical Trials in Oncology
• National Cancer Institute (NCI)

Investigators

• Study Chair: Debra Barton, RN, PhD, AOCN, FAAN, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT00719563
• Other Study ID Numbers: NCCTG-N07C2; NCI-2009-00872; CDR0000597665
• First Posted: Jul 21, 2008
• Last Update Posted: Feb 9, 2017
• Last Verified: Dec 1, 2016

• Keywords provided by Alliance for Clinical Trials in Oncology: fatigue; unspecified adult solid tumor, protocol specific; accelerated phase chronic myelogenous leukemia; acute undifferentiated leukemia; adult acute lymphoblastic leukemia in remission; adult acute myeloid leukemia in remission; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); atypical chronic myeloid leukemia, BCR-ABL1 negative; blastic phase chronic myelogenous leukemia; chronic myelomonocytic leukemia; chronic phase chronic myelogenous leukemia; mast cell leukemia; progressive hairy cell leukemia, initial treatment; prolymphocytic leukemia; recurrent adult acute lymphoblastic leukemia; recurrent adult acute myeloid leukemia; recurrent adult T-cell leukemia/lymphoma; refractory chronic lymphocytic leukemia; refractory hairy cell leukemia; relapsing chronic myelogenous leukemia; secondary acute myeloid leukemia; stage 0 chronic lymphocytic leukemia; stage I adult T-cell leukemia/lymphoma; stage I chronic lymphocytic leukemia; stage II adult T-cell leukemia/lymphoma; stage II chronic lymphocytic leukemia; stage III adult T-cell leukemia/lymphoma; stage III chronic lymphocytic leukemia; stage IV adult T-cell leukemia/lymphoma; stage IV chronic lymphocytic leukemia; T-cell large granular lymphocyte leukemia; untreated adult acute lymphoblastic leukemia; recurrent adult Hodgkin lymphoma; stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; anaplastic large cell lymphoma; angioimmunoblastic T-cell lymphoma; cutaneous B-cell non-Hodgkin lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma; stage I cutaneous T-cell non-Hodgkin lymphoma; stage II cutaneous T-cell non-Hodgkin lymphoma; stage III cutaneous T-cell non-Hodgkin lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma; recurrent mycosis fungoides/Sezary syndrome; stage I mycosis fungoides/Sezary syndrome; stage II mycosis fungoides/Sezary syndrome; stage III mycosis fungoides/Sezary syndrome; stage IV mycosis fungoides/Sezary syndrome; adult grade III lymphomatoid granulomatosis; adult nasal type extranodal NK/T-cell lymphoma; Waldenström macroglobulinemia; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma; contiguous stage II adult Burkitt lymphoma; contiguous stage II adult diffuse large cell lymphoma; contiguous stage II adult diffuse mixed cell lymphoma; contiguous stage II adult diffuse small cleaved cell lymphoma; contiguous stage II adult immunoblastic large cell lymphoma; contiguous stage II adult lymphoblastic lymphoma; contiguous stage II grade 1 follicular lymphoma; contiguous stage II grade 2 follicular lymphoma; contiguous stage II grade 3 follicular lymphoma; contiguous stage II mantle cell lymphoma; contiguous stage II marginal zone lymphoma; contiguous stage II small lymphocytic lymphoma; stage I adult Burkitt lymphoma; stage I adult diffuse large cell lymphoma; stage I adult diffuse mixed cell lymphoma; stage I adult diffuse small cleaved cell lymphoma; stage I adult immunoblastic large cell lymphoma; stage I adult lymphoblastic lymphoma; stage I grade 1 follicular lymphoma; stage I grade 2 follicular lymphoma; stage I grade 3 follicular lymphoma; stage I mantle cell lymphoma; stage I marginal zone lymphoma; stage I small lymphocytic lymphoma; noncontiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult diffuse small cleaved cell lymphoma; noncontiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II adult lymphoblastic lymphoma; noncontiguous stage II grade 1 follicular lymphoma; noncontiguous stage II grade 2 follicular lymphoma; noncontiguous stage II grade 3 follicular lymphoma; noncontiguous stage II mantle cell lymphoma; noncontiguous stage II marginal zone lymphoma; noncontiguous stage II small lymphocytic lymphoma; stage III adult Burkitt lymphoma; stage III adult diffuse large cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage III adult lymphoblastic lymphoma; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage III mantle cell lymphoma; stage III marginal zone lymphoma; stage III small lymphocytic lymphoma; stage IV adult Burkitt lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse small cleaved cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV adult lymphoblastic lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; stage IV mantle cell lymphoma; stage IV marginal zone lymphoma; stage IV small lymphocytic lymphoma; recurrent adult Burkitt lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult grade III lymphomatoid granulomatosis; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent mantle cell lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; intraocular lymphoma; post-transplant lymphoproliferative disorder; chronic eosinophilic leukemia; chronic neutrophilic leukemia; primary myelofibrosis; essential thrombocythemia; polycythemia vera; extramedullary plasmacytoma; isolated plasmacytoma of bone; monoclonal gammopathy of undetermined significance; stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; primary systemic amyloidosis; refractory multiple myeloma; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; myelodysplastic/myeloproliferative neoplasm, unclassifiable
• Additional relevant MeSH terms: Lymphoma; Leukemia; Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell; Preleukemia; Plasmacytoma; Precancerous Conditions; Myelodysplastic Syndromes; Myeloproliferative Disorders; Lymphoproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Disease; Syndrome; Fatigue

Study Results

Participant Flow

Recruitment Details	Three-hundred and sixty-four participants were recruited between October 2008 and July 2011 from 40 North Central Cancer Treatment Group (NCCTG) member sites.
Pre-assignment Detail	There were a total of 23 cancellations (12 Ginseng, 11 Placebo) and these 23 patients were excluded from all analysis.

Arm/Group Title	Ginseng	Placebo
Arm/Group Description	Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.	Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
Period Title: Overall Study
STARTED	171	170
COMPLETED	133	128
NOT COMPLETED	38	42

Baseline Characteristics

Arm/Group Title	Ginseng	Placebo	Total
Arm/Group Description	Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.	Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.	Total of all reporting groups
Overall Participants	171	170	341
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.3 (12.7)	55.9 (11.8)	55.6 (12.2)
Gender (Count of Participants)
Female	138 80.7%	128 75.3%	266 78%
Male	33 19.3%	42 24.7%	75 22%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 1.8%	1 0.6%	4 1.2%
Not Hispanic or Latino	164 95.9%	166 97.6%	330 96.8%
Unknown or Not Reported	4 2.3%	3 1.8%	7 2.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.6%	2 1.2%	3 0.9%
Asian	1 0.6%	3 1.8%	4 1.2%
Native Hawaiian or Other Pacific Islander	2 1.2%	0 0%	2 0.6%
Black or African American	10 5.8%	8 4.7%	18 5.3%
White	155 90.6%	157 92.4%	312 91.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 1.2%	0 0%	2 0.6%
Region of Enrollment (participants) [Number]
United States	171 100%	170 100%	341 100%
Menopausal status (participants) [Number]
Pre	37 21.6%	31 18.2%	68 19.9%
Post/natural-surgical	95 55.6%	90 52.9%	185 54.3%
Not applicable (Male)	33 19.3%	42 24.7%	75 22%
Unknown	6 3.5%	7 4.1%	13 3.8%
Time since current cancer diagnosis (participants) [Number]
<180 days	63 36.8%	64 37.6%	127 37.2%
180-360 days	47 27.5%	42 24.7%	89 26.1%
>360 days	61 35.7%	64 37.6%	125 36.7%
More than one primary cancer (participants) [Number]
Yes	40 23.4%	36 21.2%	76 22.3%
No	131 76.6%	134 78.8%	265 77.7%
Type of cancer (participants) [Number]
Breast	110 64.3%	96 56.5%	206 60.4%
Colon	20 11.7%	17 10%	37 10.9%
Prostate	6 3.5%	8 4.7%	14 4.1%
Hematologic	8 4.7%	9 5.3%	17 5%
Gynecologic	5 2.9%	7 4.1%	12 3.5%
Combination/unknown/other	22 12.9%	33 19.4%	55 16.1%
Currently receiving treatment (participants) [Number]
Yes	83 48.5%	83 48.8%	166 48.7%
No	88 51.5%	87 51.2%	175 51.3%
Current endocrine therapy (participants) [Number]
Tamoxifen	23 13.5%	22 12.9%	45 13.2%
Aromatase inhibitor	27 15.8%	33 19.4%	60 17.6%
Antiandrogen	2 1.2%	5 2.9%	7 2.1%
Other	7 4.1%	3 1.8%	10 2.9%
None	112 65.5%	107 62.9%	219 64.2%
Sleep aids (participants) [Number]
Yes	43 25.1%	29 17.1%	72 21.1%
No	128 74.9%	141 82.9%	269 78.9%
If taking sleep aids, how frequent? (participants) [Number]
Daily	18 10.5%	16 9.4%	34 10%
Intermittent	25 14.6%	13 7.6%	38 11.1%
Not taking sleep aids	128 74.9%	141 82.9%	269 78.9%
Exercising regularly (participants) [Number]
Yes	71 41.5%	68 40%	139 40.8%
No	98 57.3%	98 57.6%	196 57.5%
Missing	2 1.2%	4 2.4%	6 1.8%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline to Week 4 in the General Subscale of the MFSI-SF
Description	Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling "pooped, worn out, fatigued, sluggish, run down and tired". Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.
Time Frame	Baseline and week 4

Outcome Measure Data

Analysis Population Description

Includes all participants who completed both baseline and week 4 assessments.

Arm/Group Title	Ginseng	Placebo
Arm/Group Description	Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.	Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
Measure Participants	147	153
Mean (Standard Deviation) [units on a scale]	14.4 (27.1)	8.2 (24.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ginseng, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0737
	Comments
	Method	Wilcoxon Rank Sum
	Comments

2. Secondary Outcome

Title	Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence
Description	Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.
Time Frame	Week 1 to Week 8

Outcome Measure Data

Analysis Population Description

Includes all participants that reported at least one value after baseline.

Arm/Group Title	Ginseng	Placebo
Arm/Group Description	Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.	Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment..
Measure Participants	168	169
Grade 2 Nausea	5 2.9%	3 1.8%
Grade 2 Vomiting	2 1.2%	2 1.2%
Grade 2 Insomnia	9 5.3%	10 5.9%
Grade 3 Insomnia	1 0.6%	1 0.6%
Grade 2 Anxiety	4 2.3%	5 2.9%
Grade 2 Agitation	2 1.2%	4 2.4%

3. Secondary Outcome

Title	Change From Baseline to Week 4 in the Impact on Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF
Description	Each MFSI-SF subscale consist of 6 items on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were then converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description

Includes all participants who completed both baseline and week 4 assessments.

Arm/Group Title	Ginseng	Placebo
Arm/Group Description	Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.	Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
Measure Participants	147	152
Physical	1.6 (15.9)	-0.4 (14.7)
Mental	2.0 (15.2)	0.6 (16.1)
Emotional	0.5 (16.1)	0.5 (16.7)
Vigor	1.8 (19.0)	0.4 (15.5)

4. Secondary Outcome

Title	Change From Baseline to Week 4 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue
Description	Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description

Includes all participants who completed both baseline and week 4 assessments.

Arm/Group Title	Ginseng	Placebo
Arm/Group Description	Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.	Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
Measure Participants	150	150
Fatigue Usual	11.9 (25.7)	9.9 (23.4)
Fatigue Now	11.8 (26.4)	7.9 (24.1)
Fatigue Worst	11.8 (25.6)	9.7 (25.3)
BFT Total Interference	9.2 (22.0)	5.8 (21.1)

5. Secondary Outcome

Title	Change From Baseline to Week 4 Vigor/Activity and Fatigue-inertia as Measured by POMS
Description	Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The scores were then transformed into a 100-point scale with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description

Includes all participants who completed both baseline and week 4 assessments.

Arm/Group Title	Ginseng	Placebo
Arm/Group Description	Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.	Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
Measure Participants	139	142
Vigor/Activity	5.0 (18.7)	3.9 (17.3)
Fatigue/Inertial	14.5 (25.0)	7.7 (23.6)

6. Secondary Outcome

Title	Change From Baseline to Week 4 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)
Description	PSS consist of 14 items that assess the impact on stress in a 5-points scale (0=never, 1=almost never, 2=sometimes, 3=fairly often and 4=very often). The total scores were the sum of all 14 items. The scores were then transformed into a 100-point scale with higher numbers indication less stress. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description

Includes all participants who completed both baseline and week 4 assessments.

Arm/Group Title	Ginseng	Placebo
Arm/Group Description	Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.	Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
Measure Participants	148	148
Mean (Standard Deviation) [units on a scale]	-3.1 (11.1)	-3.2 (10.5)

7. Secondary Outcome

Title	Change From Baseline to Week 8 in the Impact on General, Physical, Mental, and Emotional States and Vigor as Measured by Other Subscales of the MFSI-SF
Description	Each MFSI-SF subscale consist of 6 items on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were then converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.
Time Frame	Baseline and week 8

Outcome Measure Data

Analysis Population Description

Includes all participants who completed both baseline and week 8 assessments.

Arm/Group Title	Ginseng	Placebo
Arm/Group Description	Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.	Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
Measure Participants	138	133
General	20 (27.0)	10.3 (26.1)
Physical	3.0 (17.9)	-1.7 (18.2)
Mental	2.8 (16.5)	3.4 (15.2)
Emotional	3.0 (17.4)	2.3 (17.4)
Vigor	4.6 (20.5)	2.5 (17.6)

8. Secondary Outcome

Title	Change From Baseline to Week 8 Fatigue as Measured by the BFI and Linear Analogue Scale of Fatigue
Description	Brief Fatigue Inventory (BFI) consist of 3 items that assess the severity of fatigue and 6 items that assess the impact of fatigue on daily functioning in a 10-points scale with 0 as no fatigue or does not interfere with daily functioning and 10 as bad fatigue or completely interferes. The scores for the six items were summed up to form a total interference score. The linear analogue scale of fatigue was a 10-points scale with 0 as no fatigue and 10 as bad fatigue. All scores were then transformed into 0 to 100 scale, with 100 as less fatigue/less interference. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.
Time Frame	Baseline and Week 8

Outcome Measure Data

Analysis Population Description

Includes all participants who completed both baseline and week 8 assessments.

Arm/Group Title	Ginseng	Placebo
Arm/Group Description	Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.	Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
Measure Participants	138	136
Fatigue Usual	16.4 (23.9)	11.5 (23.8)
Fatigue Now	17.6 (27.1)	8.1 (26.7)
Fatigue Worst	16.6 (27.2)	10.0 (26.9)
BFI Total Interference	12.9 (25.6)	9.0 (23.0)

9. Secondary Outcome

Title	Change From Baseline to Week 8 Vigor/Activity and Fatigue-inertia as Measured by POMS
Description	Profile of Mood States (POMS) measures a variety of mood states including tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia and confusion/bewilderment. Each subscale consist of 5 items with a 5 points-scale (0=not at all, 1=a little, 2=moderately, 3=quite a bit and 4=extremely). The subscale scores were the sum of all five items. The scores were then transformed into a 100-point scale with higher numbers indicating less fatigue. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.
Time Frame	Baseline and week 8

Outcome Measure Data

Analysis Population Description

Includes all participants who completed both baseline and week 8 assessments.

Arm/Group Title	Ginseng	Placebo
Arm/Group Description	Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.	Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
Measure Participants	132	128
Vigor/Activity	8.2 (19.8)	6.4 (19.8)
Fatigue/Inertia	18.6 (24.8)	10.2 (26.1)

10. Secondary Outcome

Title	Change From Baseline to Week 8 for the Impact on Stress as Measured by Perceived Stress Scale (PSS)
Description	PSS consist of 14 items that assess the impact on stress in a 5-points scale (0=never, 1=almost never, 2=sometimes, 3=fairly often and 4=very often). The total scores were the sum of all 14 items. The scores were then transformed into a 100-point scale with higher numbers indication less stress. Change from baseline to week 8 was calculated by subtracting the baseline scores from the scores at week 8.
Time Frame	Baseline and Week 8

Outcome Measure Data

Analysis Population Description

Includes all participants who completed both baseline and week 8 assessments.

Arm/Group Title	Ginseng	Placebo
Arm/Group Description	Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.	Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
Measure Participants	138	131
Mean (Standard Deviation) [units on a scale]	-5.2 (11.7)	-4.7 (10.8)

11. Secondary Outcome

Title	Average Change From Baseline to Week 4 in Fatigue for Those Who Perceive a Change of +2 and +3
Description	Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale (LASA) fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description

Includes all participants who completed both baseline and week 4 assessments with a perceived change in fatigue via the global impression score of a +2 and +3 at week 4.

Arm/Group Title	Ginseng	Placebo
Arm/Group Description	Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.	Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
Measure Participants	25	24
MFSI-SF General	38.8 (23.3)	29.2 (21.5)
MFSI-SF Physical	12.2 (18.3)	5.7 (15.1)
MFSI-SF Mental	8.9 (18.8)	2.6 (14.9)
MFSI-SF Emotional	8.0 (14.4)	8.7 (16.8)
MFSI-SF Vigor	13.4 (22.6)	12.0 (13.8)
BFI Total Interference	27.3 (23.7)	22.3 (15.2)
LASA Fatigue	40.9 (27.0)	37.0 (19.0)

12. Secondary Outcome

Title	Average Change From Baseline to Week 8 in Fatigue for Those Who Perceive a Change of +2 and +3
Description	Changes in fatigue as measured using subscales of MFSI-SF, the interference scale of the BFI and the linear analogue scale fatigue question were compared between arms for those participants who express a perceived change in fatigue via the global impression score of a +2 (moderately better) and +3 (very much better).
Time Frame	Baseline and Week 8

Outcome Measure Data

Analysis Population Description

Includes all participants who completed both baseline and week 8 assessments with a perceived change in fatigue via the global impression score of a +2 and +3 at week 8.

Arm/Group Title	Ginseng	Placebo
Arm/Group Description	Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.	Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
Measure Participants	34	35
MFSI-SF General	35.7 (24.7)	30.6 (22.5)
MFSI-SF Physical	7.6 (17.5)	3.8 (20.8)
MFSI-SF Mental	5.3 (19.0)	5.3 (16.1)
MFSI-SF Emotional	9.8 (14.8)	9.8 (15.9)
MFSI-SF Vigor	18.0 (18.5)	12.6 (13.2)
BFI Total Interference	30.6 (23.5)	20.9 (20.5)
LASA Fatigue	41.8 (19.5)	38.1 (18.3)

13. Secondary Outcome

Title	Change From Baseline to Week 4 in the General Subscale of the MFSI-SF for Minority Populations
Description	Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) general subscale is a six-item subscale to measure the subjective experience of fatigue. The items include feeling "pooped, worn out, fatigued, sluggish, run down and tired". Answers are on a 5-point scale, ranging from 0 (not at all) to 4 (extremely). The subscale scores were the sum of all six items. The scores were converted to a 100-point scale, with higher numbers indicating less fatigue. Change from baseline to week 4 was calculated by subtracting the baseline scores from the scores at week 4.
Time Frame	Baseline and Week 4

Outcome Measure Data

Analysis Population Description

The analysis was not able to be done due to the low numbers of minorities accrued.

Arm/Group Title	Ginseng	Placebo
Arm/Group Description	Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.	Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
Measure Participants	0	0

Adverse Events

Arm/Group Title	Ginseng		Placebo
Arm/Group Description	Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.		Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
All Cause Mortality
	Ginseng		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ginseng		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/168 (0.6%)		5/169 (3%)
Blood and lymphatic system disorders
Febrile neutropenia	1/168 (0.6%)	1	0/169 (0%)	0
Gastrointestinal disorders
Diarrhea	0/168 (0%)	0	1/169 (0.6%)	1
Investigations
Neutrophil count decreased	0/168 (0%)	0	1/169 (0.6%)	1
Psychiatric disorders
Agitation	0/168 (0%)	0	1/169 (0.6%)	1
Anxiety	0/168 (0%)	0	1/169 (0.6%)	1
Insomnia	0/168 (0%)	0	2/169 (1.2%)	3
Other (Not Including Serious) Adverse Events
	Ginseng		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	115/168 (68.5%)		112/169 (66.3%)
Blood and lymphatic system disorders
Hemoglobin decreased	2/168 (1.2%)	3	0/169 (0%)	0
Cardiac disorders
Left ventricular failure	0/168 (0%)	0	1/169 (0.6%)	1
Palpitations	1/168 (0.6%)	1	0/169 (0%)	0
Sinus tachycardia	1/168 (0.6%)	1	0/169 (0%)	0
Ear and labyrinth disorders
Tinnitus	1/168 (0.6%)	4	0/169 (0%)	0
Eye disorders
Dry eye syndrome	1/168 (0.6%)	1	0/169 (0%)	0
Gastrointestinal disorders
Abdominal pain	1/168 (0.6%)	1	1/169 (0.6%)	1
Colonic obstruction	1/168 (0.6%)	1	0/169 (0%)	0
Diarrhea	2/168 (1.2%)	2	0/169 (0%)	0
Dyspepsia	0/168 (0%)	0	1/169 (0.6%)	2
Flatulence	0/168 (0%)	0	1/169 (0.6%)	2
Mucositis oral	0/168 (0%)	0	1/169 (0.6%)	1
Nausea	55/168 (32.7%)	119	51/169 (30.2%)	101
Tooth disorder	1/168 (0.6%)	1	0/169 (0%)	0
Vomiting	12/168 (7.1%)	18	22/169 (13%)	33
General disorders
Fatigue	3/168 (1.8%)	4	4/169 (2.4%)	6
Fever	0/168 (0%)	0	1/169 (0.6%)	1
Immune system disorders
Hypersensitivity	1/168 (0.6%)	1	0/169 (0%)	0
Infections and infestations
Abdominal infection	0/168 (0%)	0	1/169 (0.6%)	1
Tooth infection	1/168 (0.6%)	1	0/169 (0%)	0
Injury, poisoning and procedural complications
Vascular access complication	1/168 (0.6%)	1	0/169 (0%)	0
Investigations
Leukocyte count decreased	4/168 (2.4%)	6	1/169 (0.6%)	1
Lymphocyte count decreased	0/168 (0%)	0	1/169 (0.6%)	1
Neutrophil count decreased	6/168 (3.6%)	9	0/169 (0%)	0
Metabolism and nutrition disorders
Anorexia	0/168 (0%)	0	2/169 (1.2%)	2
Dehydration	1/168 (0.6%)	1	0/169 (0%)	0
Serum sodium decreased	1/168 (0.6%)	1	0/169 (0%)	0
Musculoskeletal and connective tissue disorders
Bone pain	0/168 (0%)	0	1/169 (0.6%)	1
Muscle weakness	1/168 (0.6%)	1	0/169 (0%)	0
Muscle weakness lower limb	0/168 (0%)	0	1/169 (0.6%)	1
Nervous system disorders
Dizziness	0/168 (0%)	0	1/169 (0.6%)	2
Headache	1/168 (0.6%)	1	1/169 (0.6%)	1
Neuralgia	1/168 (0.6%)	1	0/169 (0%)	0
Peripheral sensory neuropathy	1/168 (0.6%)	1	0/169 (0%)	0
Tremor	0/168 (0%)	0	1/169 (0.6%)	1
Psychiatric disorders
Agitation	28/168 (16.7%)	54	37/169 (21.9%)	96
Anxiety	40/168 (23.8%)	84	45/169 (26.6%)	110
Insomnia	80/168 (47.6%)	205	82/169 (48.5%)	218
Renal and urinary disorders
Urinary frequency	1/168 (0.6%)	1	0/169 (0%)	0
Respiratory, thoracic and mediastinal disorders
Hypoxia	1/168 (0.6%)	2	0/169 (0%)	0
Skin and subcutaneous tissue disorders
Alopecia	0/168 (0%)	0	2/169 (1.2%)	5
Dry skin	0/168 (0%)	0	1/169 (0.6%)	2
Vascular disorders
Flushing	1/168 (0.6%)	1	0/169 (0%)	0
Hot flashes	1/168 (0.6%)	1	3/169 (1.8%)	7
Hypertension	1/168 (0.6%)	1	1/169 (0.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.