S0927:Omega3-Fatty Acid Supp in Treating Muscle&Bone Pain&Stiffness in Pts W/Stg I,II,III Brst Canc Rec'v Hormone Thpy

• Sponsor: Southwest Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT01385137
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 262
• Locations: 292
• Arms: 2
• Duration (Months): 24.9
• Patients Per Site: 0.9
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: An omega-3 fatty acid-enriched nutritional supplement may help improve muscle and bone pain and stiffness caused by hormone therapy in patients with breast cancer.

PURPOSE: This randomized phase III trial is studying omega-3 fatty acid supplements in treating muscle and bone pain and stiffness in patients with stage I, stage II, or stage III breast cancer receiving hormone therapy.

Condition or Disease	Intervention/Treatment	Phase
Arthralgia; Breast Cancer; Pain	Dietary Supplement: omega-3 fatty acid; Other: placebo	Phase 3

Detailed Description

OBJECTIVES:

Primary

• To assess whether omega-3-fatty acid as compared to placebo causes a reduction in worst joint pain and/or stiffness at 12 weeks, as measured by the modified Brief Pain Inventory (BPI), in women with early-stage breast cancer and aromatase inhibitor (AI)-associated arthralgia.

Secondary

• To assess the proportion of patients who report improved versus deteriorated joint pain with omega-3-fatty acid versus placebo.

• To assess the proportion of patients who report improved versus deteriorated joint stiffness with omega-3-fatty acid versus placebo.

• To assess whether patients receiving omega-3-fatty acid compared to placebo have decreased analgesic use and increased AI adherence.

• To assess whether patients receiving omega-3-fatty acid compared to placebo have improved functioning, pain, and stiffness in the knees/hips (as measured by the Western Ontario and McMaster Universities Osteoarthritis, WOMAC) score.

• To assess whether patients receiving omega-3-fatty acid have improved functioning, pain, and stiffness in the hands (as measured by the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands, M-SACRAH).

• To assess whether patients receiving omega-3-fatty acid compared to placebo have improved functional quality of life as measured by the Functional Assessment of Cancer Therapy-Endocrine Subscale (FACT-ES) Trial Outcome Index (TOI).

• To assess whether patients receiving omega-3-fatty acid report changes for the better versus worse compared to placebo as measured by the Global Rating of Change Scale.

• To identify minimally important change in the WOMAC, M-SACRAH, and the FACT-ES Trial Outcome Index (TOI) using "a little better" or "a little worse" responses on the patient-reported global rating of change in joint pain and joint stiffness.

• To assess whether patients receiving omega-3-fatty acid compared to placebo have an improved lipid profile as measured by triglycerides, HDL, and LDL.

• To assess the toxicity of omega-3-fatty acid compared to placebo in this setting.

• To assess whether there is a difference in serum-free and total estradiol levels before and after treatment with omega-3-fatty acid compared to placebo.

• To explore whether CYP19A1 genotype correlates with severity of joint symptoms or predicts response to omega-3-fatty acid. (exploratory)

• To explore changes in hormonal and inflammatory serum biomarkers, such as IL6, TNF-α, and CRP.

• To assess whether there is a relationship between change in serum docosahexaenoic acid (DHA) and EPA and resolution of joint symptoms.

• To establish a cohort of patients (placebo group) to better characterize the natural history of the syndrome.

OUTLINE: This is a multicenter study. Patients are stratified according to prior osteoarthritis (yes vs no) and prior taxane use (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity.

• Arm II: Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection at baseline and at 12 and 24 weeks for biomarker and DNA analysis.

Patients complete the Brief Pain Inventory Short Form (BPI-SF), the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, the Modified-Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH), the FACT-ES Trial Outcome Index, and the Omega-3-fatty acid Dietary Intake questionnaires at baseline and at 6, 12, and 24 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 262 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Supportive Care
• Official Title: S0927: A Randomized Placebo-Controlled Trial of Omega-3-Fatty Acid for the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain and Stiffness In Women With Early Stage Breast Cancer, Phase III
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity.	Dietary Supplement: omega-3 fatty acid; Given orally
Placebo Comparator: Arm II Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity.	Other: placebo; Given orally

Outcome Measures

Primary Outcome Measures

1. Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score [12 weeks post-registration]

   Linear regression model-adjusted week 12 mean score by treatment group. Purpose: To assess the severity of pain Population: Patients with pain from chronic diseases or conditions such as cancer, osteoarthritis and low back pain, or with pain from acute conditions such as postoperative pain Responsiveness: Responds to both behavioral and pharmacological pain interventions Method: Self-report or interview Scoring: Higher scores indicate more pain Range: 0-10

Secondary Outcome Measures

1. Number of Patients With Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug [Up to 25 weeks]

   Only adverse events that are possibly, probably or definitely related to study drug are reported.

2. Week 12 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score [12 weeks post-registration]

   Linear regression model-adjusted week 12 mean score by treatment group The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores indicate higher symptom burden.

3. Week 12 Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) Score [12 weeks post-registration]

   Linear regression model-adjusted week 12 mean score by treatment group. Higher scores represent higher symptom burden. Range is 0 to 100.

4. Week 12 Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Score [12 weeks post-registration]

   FACT-ES measures physical, social and family, emotional, and functional well-being and endocrine symptoms. The FACT scaleshave five response levels ("not at all" to "very much"), where higher scores reflect better well-being and fewer symptoms. This scale provided a measure of the broader impact of join pain and stiffness symptoms. Score range is 0 to 220.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Histologically confirmed primary invasive adenocarcinoma of the breast

• Stage I, II, or IIIA disease

• No metastatic disease

• Must have undergone modified radical mastectomy or breast-sparing surgery and recovered

• Estrogen-receptor positive (ER+) and/or progesterone-receptor positive (PR+)

• Currently taking a third-generation aromatase inhibitor (AI) [e.g., anastrozole (Arimidex®), letrozole (Femara®), or exemestane (Aromasin®)] for ≥ 90 days prior to registration with plans to continue for ≥ 180 days after registration

• Must have completed the S092 Brief Pain Inventory (BPI)-Short Form within the past 14 days, and must have a worst pain/stiffness of ≥ 5 on the BPI (item #2) that has started or increased with AI therapy

PATIENT CHARACTERISTICS:

• Postmenopausal

• Zubrod performance status 0-2

• Willing to submit blood for serum-free estradiol, total estradiol, serum inflammatory markers (IL6, TNF-α, CRP), DHA and EPA, lipid profile (LDL, HDL, triglycerides), and DNA analysis (CYP19A1)

• Able to complete study questionnaires in English

• At least 5 years since other malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ of the breast or adequately treated stage I or II cancer from which the patient is currently in complete remission

• Patients must not have a known allergy to soy, given that the placebo is suspended in soybean oil

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 3 months since prior omega-3 fatty acid supplements and must agree to refrain from omega-3-fatty acid supplements from sources outside of this study

• More than 28 days since prior investigational agents

• No other medical therapy, alternative therapy, or physical therapy for joint pain/stiffness within the past 30 days

• Patients must not be on anticoagulation medication (i.e., heparin/warfarin) because of increased risk of bleeding within 28 days prior to registration

• Patients must not have a history of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to registration

• Patients must not be on narcotics within 14 days of registration

• Patients may have received corticosteroid treatment; however, the following criteria apply:

• Patients must not have received oral or intramuscular corticosteroids within the 28 days prior to registration

• Patients must not have received intra-articular steroids to the study, or any other, joint within 28 days prior to registration

• Patients must not have received topical analgesics (e.g., capsaicin preparations) to the study joint or any other analgesics (e.g., opiates, tramadol; with the exception of nonsteroidal antiinflammatory drugs (NSAIDs) and acetaminophen) within 14 days prior to registration

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Providence Cancer Center at Providence Hospital	Mobile	Alabama	United States	36608
2	Alaska Regional Hospital Cancer Center	Anchorage	Alaska	United States	99508
3	Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital	Fairbanks	Alaska	United States	99701
4	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
5	Highlands Oncology Group - Springdale	Rogers	Arkansas	United States	72758
6	Kaiser Permanente Medical Center - Anaheim/Orange County	Anaheim	California	United States	92807
7	Kaiser Permanente - Deer Valley	Antioch	California	United States	94531
8	Kaiser Permanente Medical Center - Baldwin Park	Baldwin Park	California	United States	91706
9	Kaiser Permanente Medical Center - Bellflower	Bellflower	California	United States	90706
10	Alta Bates Summit Comprehensive Cancer Center	Berkeley	California	United States	94704
11	Peninsula Medical Center	Burlingame	California	United States	94010
12	Kaiser Permanente Medical Center - Fontana	Fontana	California	United States	92335
13	Kaiser Permanente - Fremont	Fremont	California	United States	94538
14	Kaiser Permanente Fresno Medical Center	Fresno	California	United States	93720
15	Kaiser Permanente Medical Center - Harbor City	Harbor City	California	United States	90710
16	Kaiser Permanente Medical Center - Hayward	Hayward	California	United States	94545
17	Kaiser Permanente - Irvine	Irvine	California	United States	92618
18	Kaiser Permanente Medical Center - Los Angeles	Los Angeles	California	United States	90027
19	Kaiser Foundation Hospital - West Los Angeles	Los Angeles	California	United States	90034
20	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90089-9181
21	Contra Costa Regional Medical Center	Martinez	California	United States	94553-3156
22	Tibotec Therapeutics - Division of Ortho Biotech Products, LP	Marysville	California	United States	95901
23	Mercy Cancer Center at Mercy Medical Center	Merced	California	United States	95340
24	El Camino Hospital Cancer Center	Mountain View	California	United States	94040
25	Sutter Health - Western Division Cancer Research Group	Novato	California	United States	94945
26	Highland General Hospital	Oakland	California	United States	94602
27	Alta Bates Summit Medical Center - Summit Campus	Oakland	California	United States	94609
28	CCOP - Bay Area Tumor Institute	Oakland	California	United States	94609
29	Kaiser Permanente Medical Center - Oakland	Oakland	California	United States	94611
30	Epic Care - Oakland	Oakland	California	United States	94612
31	Kaiser Permanente Medical Group	Panorama City	California	United States	91402
32	Valley Medical Oncology Consultants - Pleasanton	Pleasanton	California	United States	94588
33	Kaiser Permanente Medical Center - Redwood City	Redwood City	California	United States	94063
34	Kaiser Permanente Medical Center - Richmond	Richmond	California	United States	94801
35	Kaiser Permanente Medical Center - Riverside	Riverside	California	United States	92505
36	Kaiser Permanente Medical Center - Roseville	Roseville	California	United States	95661
37	Sutter Cancer Center at Roseville Medical Center	Roseville	California	United States	95661
38	Sutter Cancer Center	Sacramento	California	United States	95816
39	University of California Davis Cancer Center	Sacramento	California	United States	95817
40	South Sacramento Kaiser-Permanente Medical Center	Sacramento	California	United States	95823
41	Kaiser Permanente Medical Center - Sacramento	Sacramento	California	United States	95825
42	Kaiser Permanente Medical Office -Vandever Medical Office	San Diego	California	United States	92108
43	Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego	San Diego	California	United States	92120
44	Kaiser Permanente Medical Center - San Francisco Geary Campus	San Francisco	California	United States	94115
45	California Pacific Medical Center - California Campus	San Francisco	California	United States	94118
46	Kaiser Permanente Medical Center - Santa Teresa	San Jose	California	United States	95119
47	Kaiser Permanente Health Care	San Marcos	California	United States	92078
48	Doctors Medical Center - San Pablo Campus	San Pablo	California	United States	94806
49	Kaiser Foundation Hospital - San Rafael	San Rafael	California	United States	94903
50	Kaiser Permanente Medical Center - Santa Clara Kiely Campus	Santa Clara	California	United States	95051
51	Kaiser Permanente Medical Center - Santa Rosa	Santa Rosa	California	United States	95403
52	Sutter Pacific Medical Foundation	Santa Rosa	California	United States	95403
53	Kaiser Permanente Medical Center - South San Francisco	South San Francisco	California	United States	94080
54	Kaiser Permanente Medical Facility - Stockton	Stockton	California	United States	95210
55	Tahoe Forest Cancer Center	Truckee	California	United States	96161
56	Kaiser Permanente Medical Center - Vacaville	Vacaville	California	United States	95688
57	Kaiser Permanente Medical Center - Vallejo	Vallejo	California	United States	94589
58	Sutter Solano Medical Center	Vallejo	California	United States	94589
59	Kaiser Permanente Medical Center - Walnut Creek	Walnut Creek	California	United States	94596
60	Kaiser Permanente Medical Cener - Woodland Hills	Woodland Hills	California	United States	91367
61	Kaiser Permanente - Denver	Denver	Colorado	United States	80205
62	Poudre Valley Hospital	Fort Collins	Colorado	United States	80524
63	Front Range Cancer Specialists	Fort Collins	Colorado	United States	80528
64	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut	United States	06105
65	Broward General Medical Center Cancer Center	Fort Lauderdale	Florida	United States	33316
66	Northeast Georgia Medical Center	Gainesville	Georgia	United States	30501
67	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center	Savannah	Georgia	United States	31403-3089
68	Kaiser Permanente - Moanalua Medical Center and Clinic	Honolulu	Hawaii	United States	96819
69	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center	Boise	Idaho	United States	83706
70	Mountain States Tumor Institute at St. Luke's Regional Medical Center	Boise	Idaho	United States	83712
71	Saint Luke's Mountain States Tumor Institute - Fruitland	Fruitland	Idaho	United States	83619
72	St. Joseph Regional Medical Center	Lewiston	Idaho	United States	83501
73	Mountain States Tumor Institute - Meridian	Meridian	Idaho	United States	83642
74	Saint Luke's Mountain States Tumor Institute	Nampa	Idaho	United States	83686
75	Mountain States Tumor Institute at St. Luke's	Twin Falls	Idaho	United States	83301
76	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
77	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153
78	Good Samaritan Regional Health Center	Mount Vernon	Illinois	United States	62864
79	Edward Hospital Cancer Center	Naperville	Illinois	United States	60540
80	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois	United States	62781-0001
81	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana	United States	46107
82	Reid Hospital & Health Care Services	Richmond	Indiana	United States	47374
83	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa	United States	52803
84	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas	United States	66720
85	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
86	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas	United States	66701
87	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
88	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas	United States	67068
89	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
90	Cancer Center of Kansas, PA - Liberal	Liberal	Kansas	United States	67901
91	Cancer Center of Kansas, PA - Newton	Newton	Kansas	United States	67114
92	Menorah Medical Center	Overland Park	Kansas	United States	66209
93	Saint Luke's Hospital - South	Overland Park	Kansas	United States	66213
94	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas	United States	67357
95	CCOP - Kansas City	Prairie Village	Kansas	United States	66208
96	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas	United States	67124
97	Cancer Center of Kansas, PA - Salina	Salina	Kansas	United States	67401
98	Cotton-O'Neil Cancer Center	Topeka	Kansas	United States	66606
99	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas	United States	67152
100	Associates in Womens Health, PA - North Review	Wichita	Kansas	United States	67208
101	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas	United States	67208
102	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas	United States	67214
103	CCOP - Wichita	Wichita	Kansas	United States	67214
104	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
105	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas	United States	67156
106	Central Baptist Hospital	Lexington	Kentucky	United States	40503-9985
107	CHRISTUS Cabrini Cancer Center	Alexandria	Louisiana	United States	71301
108	Louisiana State University Health Sciences Center - Monroe	Monroe	Louisiana	United States	71210
109	Highland Clinic	Shreveport	Louisiana	United States	71105
110	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana	United States	71130-3932
111	Alvin and Lois Lapidus Cancer Institute at Sinai Hospital	Baltimore	Maryland	United States	21215
112	Lahey Clinic Medical Center - Burlington	Burlington	Massachusetts	United States	01805
113	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
114	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
115	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0942
116	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan	United States	49017
117	Bay Regional Medical Center	Bay City	Michigan	United States	48708
118	Mecosta County Medical Center	Big Rapids	Michigan	United States	49307
119	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
120	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan	United States	48202
121	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
122	Hurley Medical Center	Flint	Michigan	United States	48503
123	McLaren Cancer Institute	Flint	Michigan	United States	48532
124	Singh and Arora Hematology Oncology, PC	Flint	Michigan	United States	48532
125	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan	United States	49503
126	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
127	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan	United States	49503
128	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
129	Foote Memorial Hospital	Jackson	Michigan	United States	49201
130	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
131	Great Lakes Cancer Institute - Lapeer Campus	Lapeer	Michigan	United States	48446
132	St. Mary Mercy Hospital	Livonia	Michigan	United States	48154
133	Clemens Regional Medical Center	Mount Clemens	Michigan	United States	48043
134	Mercy General Health Partners	Muskegon	Michigan	United States	49444
135	Northern Michigan Hospital	Petoskey	Michigan	United States	49770
136	St. Joseph Mercy Oakland	Pontiac	Michigan	United States	48341-2985
137	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
138	Spectrum Health Reed City Hospital	Reed City	Michigan	United States	49677
139	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
140	Providence Cancer Institute at Providence Hospital - Southfield Campus	Southfield	Michigan	United States	48075
141	Munson Medical Center	Traverse City	Michigan	United States	49684
142	St. John Macomb Hospital	Warren	Michigan	United States	48093
143	University of Mississippi Cancer Clinic	Jackson	Mississippi	United States	39216
144	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi	United States	39581
145	Central Care Cancer Center at Carrie J. Babb Cancer Center	Bolivar	Missouri	United States	65613
146	Saint Francis Medical Center	Cape Girardeau	Missouri	United States	63703
147	Saint Luke's Cancer Institute at Saint Luke's Hospital	Kansas City	Missouri	United States	64111
148	North Kansas City Hospital	Kansas City	Missouri	United States	64116
149	Heartland Hematology Oncology Associates, Incorporated	Kansas City	Missouri	United States	64118
150	Research Medical Center	Kansas City	Missouri	United States	64132
151	Saint Luke's East - Lee's Summit	Lee's Summit	Missouri	United States	64086
152	Parvin Radiation Oncology	Liberty	Missouri	United States	64068
153	Phelps County Regional Medical Center	Rolla	Missouri	United States	65401
154	Heartland Regional Medical Center	Saint Joseph	Missouri	United States	64506
155	Midwest Hematology Oncology Group, Incorporated	Saint Louis	Missouri	United States	63109
156	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri	United States	63141
157	David C. Pratt Cancer Center at St. John's Mercy	Saint Louis	Missouri	United States	63141
158	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65802
159	St. John's Regional Health Center	Springfield	Missouri	United States	65804
160	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
161	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
162	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
163	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59102
164	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
165	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
166	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
167	St. Peter's Hospital	Helena	Montana	United States	59601
168	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
169	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
170	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
171	Good Samaritan Cancer Center at Good Samaritan Hospital	Kearney	Nebraska	United States	68848-1990
172	Lovelace Medical Center - Downtown	Albuquerque	New Mexico	United States	87102
173	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87131-5636
174	Falck Cancer Center at Arnot Ogden Medical Center	Elmira	New York	United States	14905
175	Tucker Center for Cancer Care at Orange Regional Medical Center	Middletown	New York	United States	10940-4199
176	Winthrop University Hospital	Mineola	New York	United States	11501
177	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	New York	New York	United States	10032
178	Highland Hospital of Rochester	Rochester	New York	United States	14620
179	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
180	Randolph Hospital	Asheboro	North Carolina	United States	27203-5400
181	Mission Hospitals - Memorial Campus	Asheville	North Carolina	United States	28801
182	Presbyterian Cancer Center at Presbyterian Hospital	Charlotte	North Carolina	United States	28233-3549
183	CaroMont Cancer Center at Gaston Memorial Hospital	Gastonia	North Carolina	United States	28053
184	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
185	Moses Cone Regional Cancer Center at Wesley Long Community Hospital	Greensboro	North Carolina	United States	27403-1198
186	Pardee Memorial Hospital	Hendersonville	North Carolina	United States	28791
187	Iredell Memorial Hospital	Statesville	North Carolina	United States	28677
188	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio	United States	44307
189	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
190	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
191	CCOP - Columbus	Columbus	Ohio	United States	43215
192	Grant Medical Center Cancer Care	Columbus	Ohio	United States	43215
193	Mount Carmel Health - West Hospital	Columbus	Ohio	United States	43222
194	Doctors Hospital at Ohio Health	Columbus	Ohio	United States	43228
195	Grandview Hospital	Dayton	Ohio	United States	45405
196	Good Samaritan Hospital	Dayton	Ohio	United States	45406
197	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio	United States	45409
198	Samaritan North Cancer Care Center	Dayton	Ohio	United States	45415
199	CCOP - Dayton	Dayton	Ohio	United States	45420
200	Grady Memorial Hospital	Delaware	Ohio	United States	43015
201	Blanchard Valley Medical Associates	Findlay	Ohio	United States	45840
202	Middletown Regional Hospital	Franklin	Ohio	United States	45005-1066
203	Wayne Hospital	Greenville	Ohio	United States	45331
204	Charles F. Kettering Memorial Hospital	Kettering	Ohio	United States	45429
205	Fairfield Medical Center	Lancaster	Ohio	United States	43130
206	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio	United States	45750
207	Knox Community Hospital	Mount Vernon	Ohio	United States	43050
208	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio	United States	43055
209	Southern Ohio Medical Center Cancer Center	Portsmouth	Ohio	United States	45662
210	Community Hospital of Springfield and Clark County	Springfield	Ohio	United States	45505
211	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio	United States	45373-1300
212	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio	United States	43081
213	United States Air Force Medical Center - Wright-Patterson	Wright-Patterson Afb	Ohio	United States	45433-5529
214	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio	United States	45385
215	Genesis - Good Samaritan Hospital	Zanesville	Ohio	United States	43701
216	St. Charles Medical Center - Bend	Bend	Oregon	United States	97701
217	Clackamas Radiation Oncology Center	Clackamas	Oregon	United States	97015
218	Legacy Mount Hood Medical Center	Gresham	Oregon	United States	97030
219	Providence Milwaukie Hospital	Milwaukie	Oregon	United States	97222
220	Providence Newberg Medical Center	Newberg	Oregon	United States	97132
221	Willamette Falls Hospital	Oregon City	Oregon	United States	97045
222	Legacy Good Samaritan Hospital & Comprehensive Cancer Center	Portland	Oregon	United States	97210
223	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon	United States	97213-2967
224	CCOP - Columbia River Oncology Program	Portland	Oregon	United States	97225
225	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
226	Legacy Emanuel Hospital and Health Center and Children's Hospital	Portland	Oregon	United States	97227
227	Salem Hospital Regional Cancer Care Services	Salem	Oregon	United States	97309-5014
228	Legacy Meridian Park Hospital	Tualatin	Oregon	United States	97062
229	AnMed Cancer Center	Anderson	South Carolina	United States	29621
230	McLeod Regional Medical Center	Florence	South Carolina	United States	29501
231	Bon Secours St. Francis Health System	Greenville	South Carolina	United States	29601
232	Cancer Centers of the Carolinas - Faris Road	Greenville	South Carolina	United States	29605
233	Cancer Centers of the Carolinas - Grove Commons	Greenville	South Carolina	United States	29605
234	CCOP - Greenville	Greenville	South Carolina	United States	29615
235	Self Regional Cancer Center at Self Regional Medical Center	Greenwood	South Carolina	United States	29646
236	Cancer Centers of the Carolinas - Greer Medical Oncology	Greer	South Carolina	United States	29650
237	Carolina Blood and Cancer Care Associates, PA	Lancaster	South Carolina	United States	29720
238	Carolina Blood and Cancer Care	Rock Hill	South Carolina	United States	29732
239	Cancer Centers of the Carolinas - Seneca	Seneca	South Carolina	United States	29672
240	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
241	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
242	Cancer Centers of the Carolinas - Spartanburg	Spartanburg	South Carolina	United States	29307
243	Thompson Cancer Survival Center	Knoxville	Tennessee	United States	37916
244	Baylor University Medical Center - Dallas	Dallas	Texas	United States	75246
245	Methodist Hospital	Houston	Texas	United States	77030
246	Baylor Medical Center at Irving	Irving	Texas	United States	75061
247	American Fork Hospital	American Fork	Utah	United States	84003
248	Sandra L. Maxwell Cancer Center	Cedar City	Utah	United States	84720
249	Logan Regional Hospital	Logan	Utah	United States	84321
250	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center	Murray	Utah	United States	84157
251	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center	Ogden	Utah	United States	84403
252	Utah Valley Regional Medical Center - Provo	Provo	Utah	United States	84604
253	Dixie Regional Medical Center - East Campus	Saint George	Utah	United States	84770
254	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah	United States	84112
255	LDS Hospital	Salt Lake City	Utah	United States	84143
256	Danville Regional Medical Center	Danville	Virginia	United States	24541
257	Island Hospital Cancer Care Center at Island Hospital	Anacortes	Washington	United States	98221
258	St. Joseph Cancer Center	Bellingham	Washington	United States	98225
259	Olympic Hematology and Oncology	Bremerton	Washington	United States	98310
260	Highline Medical Center Cancer Center	Burien	Washington	United States	98166
261	Providence Centralia Hospital	Centralia	Washington	United States	98531-9027
262	Providence Regional Cancer Partnership	Everett	Washington	United States	98201
263	St. Francis Hospital	Federal Way	Washington	United States	98003
264	Swedish Medical Center - Issaquah Campus	Issaquah	Washington	United States	98029
265	Columbia Basin Hematology	Kennewick	Washington	United States	99336
266	Cascade Cancer Center at Evergreen Hospital Medical Center	Kirkland	Washington	United States	98033
267	Skagit Valley Hospital Cancer Care Center	Mount Vernon	Washington	United States	98274
268	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington	United States	98506-5166
269	Harrison Poulsbo Hematology and Onocology	Poulsbo	Washington	United States	98370
270	Good Samaritan Cancer Center	Puyallup	Washington	United States	98372
271	CCOP - Virginia Mason Research Center	Seattle	Washington	United States	98101
272	Harborview Medical Center	Seattle	Washington	United States	98104
273	Minor and James Medical, PLLC	Seattle	Washington	United States	98104
274	Pacific Medical Center	Seattle	Washington	United States	98104
275	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109
276	Group Health Central Hospital	Seattle	Washington	United States	98112
277	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98122-4307
278	Polyclinic First Hill	Seattle	Washington	United States	98122
279	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195
280	North Puget Oncology at United General Hospital	Sedro-Woolley	Washington	United States	98284
281	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
282	Evergreen Hematology and Oncology, PS	Spokane	Washington	United States	99218
283	Franciscan Cancer Center at St. Joseph Medical Center	Tacoma	Washington	United States	98405-3004
284	Allenmore Hospital	Tacoma	Washington	United States	98405
285	CCOP - Northwest	Tacoma	Washington	United States	98405
286	MultiCare Regional Cancer Center at Tacoma General Hospital	Tacoma	Washington	United States	98405
287	St. Clare Hospital	Tacoma	Washington	United States	98499
288	Southwest Washington Medical Center Cancer Center	Vancouver	Washington	United States	98664
289	Legacy Salmon Creek Medical Center	Vancouver	Washington	United States	98686
290	Wenatchee Valley Medical Center	Wenatchee	Washington	United States	98801-2028
291	North Star Lodge Cancer Center at Yakima Valley Memorial Hospital	Yakima	Washington	United States	98902
292	Rocky Mountain Oncology	Casper	Wyoming	United States	82609

Sponsors and Collaborators

• Southwest Oncology Group
• National Cancer Institute (NCI)

Investigators

• Study Chair: Dawn Hershman, MD, Herbert Irving Comprehensive Cancer Center
• Principal Investigator: Laurence H. Baker, DO, FACOI, University of Michigan Rogel Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Southwest Oncology Group
• ClinicalTrials.gov Identifier: NCT01385137
• Other Study ID Numbers: S0927; S0927; U10CA037429
• First Posted: Jun 29, 2011
• Last Update Posted: Apr 7, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Southwest Oncology Group: estrogen receptor-positive breast cancer; progesterone receptor-positive breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; pain; arthralgia
• Additional relevant MeSH terms: Breast Neoplasms; Arthralgia

Study Results

Participant Flow

Arm/Group Title	Arm I (Omega-3-fatty Acid)	Arm II (Placebo)
Arm/Group Description	Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity	Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
Period Title: Evaluable at Baseline
STARTED	131	131
COMPLETED	122	127
NOT COMPLETED	9	4
Period Title: Evaluable at Baseline
STARTED	131	131
COMPLETED	102	107
NOT COMPLETED	29	24

Baseline Characteristics

Arm/Group Title	Arm I (Omega-3-fatty Acid)	Arm II (Placebo)	Total
Arm/Group Description	Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity	Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity	Total of all reporting groups
Overall Participants	122	127	249
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	59.5	59.1	59.2
Sex: Female, Male (Count of Participants)
Female	122 100%	127 100%	249 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 5.7%	9 7.1%	16 6.4%
Not Hispanic or Latino	112 91.8%	113 89%	225 90.4%
Unknown or Not Reported	3 2.5%	5 3.9%	8 3.2%
Race/Ethnicity, Customized (Count of Participants)
White	113 92.6%	104 81.9%	217 87.1%
Black	5 4.1%	15 11.8%	20 8%
Asian	1 0.8%	3 2.4%	4 1.6%
Native American	0 0%	1 0.8%	1 0.4%
Multiracial	1 0.8%	1 0.8%	2 0.8%
Unknown	2 1.6%	3 2.4%	5 2%
Osteoarthritis (Count of Participants)
Yes	28 23%	29 22.8%	57 22.9%
No	94 77%	98 77.2%	192 77.1%

Outcome Measures

1. Primary Outcome

Title	Week 12 Brief Pain Inventory (BPI) Worst Pain/Stiffness Score
Description	Linear regression model-adjusted week 12 mean score by treatment group. Purpose: To assess the severity of pain Population: Patients with pain from chronic diseases or conditions such as cancer, osteoarthritis and low back pain, or with pain from acute conditions such as postoperative pain Responsiveness: Responds to both behavioral and pharmacological pain interventions Method: Self-report or interview Scoring: Higher scores indicate more pain Range: 0-10
Time Frame	12 weeks post-registration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Omega-3-fatty Acid)	Arm II (Placebo)
Arm/Group Description	Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity	Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
Measure Participants	102	107
Mean (95% Confidence Interval) [BPI score]	5.3	5.47

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Omega-3-fatty Acid), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.58
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 95%; -0.79 to 0.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Number of Patients With Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
Description	Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time Frame	Up to 25 weeks

Outcome Measure Data

Analysis Population Description

All participants receiving at least some protocol treatment

Arm/Group Title	Arm I (Omega-3-fatty Acid)	Arm II (Placebo)
Arm/Group Description	Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity	Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
Measure Participants	117	124
Arthralgia	0 0%	1 0.8%
Diarrhea	1 0.8%	0 0%
Dyspepsia	1 0.8%	0 0%
Pain	0 0%	1 0.8%
Pain in extremity	1 0.8%	0 0%
Peripheral motor neuropathy	0 0%	1 0.8%
Rash maculo-papular	0 0%	1 0.8%

3. Secondary Outcome

Title	Week 12 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Description	Linear regression model-adjusted week 12 mean score by treatment group The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores indicate higher symptom burden.
Time Frame	12 weeks post-registration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Omega-3-fatty Acid)	Arm II (Placebo)
Arm/Group Description	Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity	Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
Measure Participants	102	107
Mean (95% Confidence Interval) [WOMAC score]	34.5	36.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Omega-3-fatty Acid), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.42
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.13
	Confidence Interval	(2-Sided) 95%; -7.30 to 3.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Week 12 Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) Score
Description	Linear regression model-adjusted week 12 mean score by treatment group. Higher scores represent higher symptom burden. Range is 0 to 100.
Time Frame	12 weeks post-registration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Omega-3-fatty Acid)	Arm II (Placebo)
Arm/Group Description	Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity	Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
Measure Participants	100	107
Mean (95% Confidence Interval) [M-SACRAH score]	28.8	28.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Omega-3-fatty Acid), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.77
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 95%; -4.17 to 5.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Week 12 Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) Score
Description	FACT-ES measures physical, social and family, emotional, and functional well-being and endocrine symptoms. The FACT scaleshave five response levels ("not at all" to "very much"), where higher scores reflect better well-being and fewer symptoms. This scale provided a measure of the broader impact of join pain and stiffness symptoms. Score range is 0 to 220.
Time Frame	12 weeks post-registration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Omega-3-fatty Acid)	Arm II (Placebo)
Arm/Group Description	Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity	Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
Measure Participants	100	107
Mean (95% Confidence Interval) [FACT-ES score]	95	92.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Omega-3-fatty Acid), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.21
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.14
	Confidence Interval	(2-Sided) 95%; -1.16 to 5.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Up to 25 weeks
Arm/Group Title	Arm I (Omega-3-fatty Acid)		Arm II (Placebo)
Arm/Group Description	Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity		Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
All Cause Mortality
	Arm I (Omega-3-fatty Acid)		Arm II (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm I (Omega-3-fatty Acid)		Arm II (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/117 (0%)		0/124 (0%)
Other (Not Including Serious) Adverse Events
	Arm I (Omega-3-fatty Acid)		Arm II (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	70/117 (59.8%)		74/124 (59.7%)
Gastrointestinal disorders
Bloating	7/117 (6%)		2/124 (1.6%)
Diarrhea	18/117 (15.4%)		11/124 (8.9%)
Dyspepsia	23/117 (19.7%)		16/124 (12.9%)
Nausea	12/117 (10.3%)		17/124 (13.7%)
General disorders
Fatigue	6/117 (5.1%)		8/124 (6.5%)
Musculoskeletal and connective tissue disorders
Arthralgia	55/117 (47%)		63/124 (50.8%)
Joint range of motion decreased	11/117 (9.4%)		15/124 (12.1%)
Nervous system disorders
Headache	3/117 (2.6%)		7/124 (5.6%)
Vascular disorders
Hot flashes	4/117 (3.4%)		8/124 (6.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.