S0715: Acetyl-L-Carnitine in Preventing Neuropathy in Women With Stage I, II, or IIIA Breast Cancer Undergoing Chemo

• Sponsor: Southwest Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00775645
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 437
• Locations: 295
• Arms: 2
• Duration (Months): 45
• Patients Per Site: 1.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Acetyl-L-carnitine may prevent or lessen neuropathy caused by chemotherapy. It is not yet known whether acetyl-L-carnitine is more effective than a placebo in preventing neuropathy caused by chemotherapy.

PURPOSE: This randomized phase III trial is studying acetyl-L-carnitine to see how well it works compared with a placebo in preventing neuropathy in women with stage I, stage II, or stage III breast cancer undergoing chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Chemotherapeutic Agent Toxicity; Fatigue; Neuropathy; Neurotoxicity	Dietary Supplement: acetyl-L-carnitine hydrochloride; Other: placebo	Phase 3

Detailed Description

OBJECTIVES:

Primary

• Compare whether treatment with acetyl-L-carnitine hydrochloride vs placebo prevents symptoms of neuropathy as measured by the 11-item neurotoxicity component of the FACT-Taxane Questionnaire at 12 weeks after study registration in women with stage I, II, or IIIA breast cancer undergoing adjuvant taxane-based chemotherapy.

Secondary

• Compare the functional status of these patients using the Trial Outcome Index from the Functional Assessment of Cancer Therapy (FACT)-Taxane Questionnaire.

• Compare fatigue in these patients using the Function Assessment of Chronic Illness Therapy (FACIT)-Fatigue Symptom Module.

Other

• Compare the proportion of patients experiencing grade 3 or 4 neuropathy.

• Compare serum nerve growth factor levels in these patients.

• Describe the total dose of taxane received and treatment delays, compliance with therapy, and use of concurrent medications, dietary supplements (e.g., glutamine), vitamin E, and complementary and alternative medicines in these patients.

• Explore the relationship between nerve growth factor levels and the degree of neuropathy and functional status in these patients.

• Explore the relationship between genetic markers responsible for taxane metabolism and clearance (e.g., CYP2C8, CYP3A4, CYP3A5, GSTM1, and GSTP1) and the degree of neuropathy in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to planned adjuvant chemotherapy regimen for breast cancer (paclitaxel weekly for 12 weeks vs paclitaxel biweekly for 4 courses [8 weeks] vs paclitaxel biweekly for 6 courses [12 weeks] vs docetaxel every 3 weeks for 4 courses [12 weeks] vs docetaxel every 3 weeks for 6 courses [18 weeks]) and age (< 60 years vs ≥ 60 years). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks.

• Arm II: Patients receive oral placebo 3 times daily for 24 weeks. Patients complete the FACT-Taxane Trial Outcome Index and the FACIT-Fatigue Symptom Module questionnaires at baseline, at 12, 24, and 36 weeks, and at 1 and 2 years.

Blood samples are collected at baseline and at week 12 for biomarker analysis (nerve growth factor levels) by ELISA, DNA extraction, and genotyping analysis.

Study Design

• Study Type: Interventional
• Actual Enrollment: 437 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: S0715: Randomized Placebo-Controlled Trial of Acetyl-L-Carnitine (ALC) for the Prevention of Taxane Induced Neuropathy Phase III
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks.	Dietary Supplement: acetyl-L-carnitine hydrochloride; Given orally
Placebo Comparator: Arm II Patients receive oral placebo 3 times daily for 24 weeks.	Other: placebo; Given orally

Outcome Measures

Primary Outcome Measures

1. 12-week FACT-Taxane Neurotoxicity Model-adjusted Score in ALC and Placebo Groups [12 weeks post-registration]

   Compare whether treatment with acetyl-L-carnitine hydrochloride vs placebo prevents symptoms of neuropathy as measured by the 11-item neurotoxicity (NTX) component of the Functional Assesment of Cancer Therapy (FACT)-Taxane Questionnaire at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate worse CIPN. Total possible range is 0 to 64. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires

Secondary Outcome Measures

1. 12-week FACT-Trial Outcome Index(TOI) Functional Status Model-adjusted Score in ALC and Placebo Groups [12 weeks post-registration]

   Compare FACT-TOI outcome in treatment vs placebo groups at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate worse functional status. Total possible range is 0 to 120. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires

2. 12-week FACIT-fatigue Model-adjusted Score in ALC and Placebo Groups [12 weeks post-registration]

   Compare fatigue outcome between treatment and placebo groups as measured by the 13-item Functional Assessment of Chronic Illness Therapy FACIT-fatigue questionnaire at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate more fatigue. Total possible range is 0 to 52. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires

Other Outcome Measures

1. Proportion of Patients Experiencing Grade 3 or 4 Neuropathy [12 weeks post-registration]

   Proportion of patients experiencing grade 3 or 4 neuropathy

2. Serum Nerve Growth Factor Levels [12 weeks post-registration]

3. Treatment and Concurrent Therapy [12 weeks post-registration]

   total dose of taxane received and treatment delays, compliance with therapy, and use of concurrent medications, dietary supplements (e.g., glutamine), vitamin E, and complementary and alternative medicines

4. Association Between Nerve Growth Factor Levels and the Degree of Neuropathy and Functional Status [12 weeks post-registration]

   Explore the relationship between nerve growth factor levels and the degree of neuropathy and functional status in these patients.

5. Association Between Genetic Markers Responsible for Taxane Metabolism and Clearance and the Degree of Neuropathy [12 weeks post-registration]

   Explore the relationship between genetic markers responsible for taxane metabolism and clearance (e.g., CYP2C8, CYP3A4, CYP3A5, GSTM1, and GSTP1) and the degree of neuropathy in these patients.

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-III disease

• No metastatic disease

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

• Planning to receive one of the following standard taxane-based systemic chemotherapy regimens as adjuvant therapy for breast cancer:

• Paclitaxel 80 mg/m² weekly for 12 weeks

• Paclitaxel 175 mg/m² every other week for 4 courses (8 weeks)

• Paclitaxel 175 mg/m² every other week for 6 courses (12 weeks)

• Docetaxel 75 mg/m² every 3 weeks for 4 courses (12 weeks)

• Docetaxel 75 mg/m² every 3 weeks for 6 courses (18 weeks)

• No history of neuropathy

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified

• Zubrod performance status 0-2

• Serum creatinine ≤ 2.5 times upper limit of normal

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Able to complete questionnaires in English or Spanish

• Willing to submit blood samples for DNA extraction, genotyping analysis, and nerve growth factor studies

• No history of diabetes

• No history of seizure disorder

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, ductal carcinoma in situ, or adequately treated stage I or stage II malignancy from which the patient is currently in complete remission

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Recovered from prior breast surgery

• Prior neoadjuvant or adjuvant chemotherapy allowed

• No prior taxane therapy

• No prior biologic therapy for treatment of breast cancer

• No concurrent vitamin E, glutamine, gabapentin, nortriptyline, amitriptyline, or duloxetine hydrochloride

• Multivitamins containing vitamin E allowed provided vitamin E dose is < 1,000 IU

• No concurrent anti-seizure medications

• Concurrent hormonal therapy allowed

• Concurrent biologic therapy allowed (e.g., Herceptin)

• Concurrent participation in another therapeutic clinical trial allowed

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	Providence Cancer Center	Anchorage	Alaska	United States	99508
4	Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital	Fairbanks	Alaska	United States	99701
5	Kaiser Permanente - Deer Valley	Antioch	California	United States	94531
6	Alta Bates Summit Comprehensive Cancer Center	Berkeley	California	United States	94704
7	Peninsula Medical Center	Burlingame	California	United States	94010
8	East Bay Radiation Oncology Center	Castro Valley	California	United States	94546
9	Eden Medical Center	Castro Valley	California	United States	94546
10	Valley Medical Oncology Consultants - Castro Valley	Castro Valley	California	United States	94546
11	Kaiser Permanente - Fremont	Fremont	California	United States	94538
12	Valley Medical Oncology	Fremont	California	United States	94538
13	Glendale Memorial Hospital Comprehensive Cancer Center	Glendale	California	United States	91204
14	Kaiser Permanente Medical Center - Hayward	Hayward	California	United States	94545
15	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90089-9181
16	Contra Costa Regional Medical Center	Martinez	California	United States	94553-3156
17	Tibotec Therapeutics - Division of Ortho Biotech Products, LP	Marysville	California	United States	95901
18	El Camino Hospital Cancer Center	Mountain View	California	United States	94040
19	Highland General Hospital	Oakland	California	United States	94602
20	Alta Bates Summit Medical Center - Summit Campus	Oakland	California	United States	94609
21	Bay Area Breast Surgeons, Incorporated	Oakland	California	United States	94609
22	CCOP - Bay Area Tumor Institute	Oakland	California	United States	94609
23	Larry G Strieff MD Medical Corporation	Oakland	California	United States	94609
24	Tom K Lee, Incorporated	Oakland	California	United States	94609
25	Kaiser Permanente Medical Center - Oakland	Oakland	California	United States	94611
26	Valley Care Medical Center	Pleasanton	California	United States	94588
27	Valley Medical Oncology Consultants - Pleasanton	Pleasanton	California	United States	94588
28	Kaiser Permanente Medical Center - Redwood City	Redwood City	California	United States	94063
29	Kaiser Permanente Medical Center - Richmond	Richmond	California	United States	94801
30	Kaiser Permanente Medical Center - Roseville	Roseville	California	United States	95661
31	Sutter Cancer Center at Roseville Medical Center	Roseville	California	United States	95661
32	Sutter Cancer Center	Sacramento	California	United States	95816
33	University of California Davis Cancer Center	Sacramento	California	United States	95817
34	South Sacramento Kaiser-Permanente Medical Center	Sacramento	California	United States	95823
35	Kaiser Permanente Medical Center - Sacramento	Sacramento	California	United States	95825
36	Kaiser Permanente Medical Center - San Francisco Geary Campus	San Francisco	California	United States	94115
37	California Pacific Medical Center - California Campus	San Francisco	California	United States	94118
38	Kaiser Permanente Medical Center - Santa Teresa	San Jose	California	United States	95119
39	Doctors Medical Center - San Pablo Campus	San Pablo	California	United States	94806
40	Kaiser Foundation Hospital - San Rafael	San Rafael	California	United States	94903
41	Sutter Health - Western Division Cancer Research Group	San Rafael	California	United States	94903
42	Kaiser Permanente Medical Center - Santa Clara Kiely Campus	Santa Clara	California	United States	95051
43	Kaiser Permanente Medical Center - Santa Rosa	Santa Rosa	California	United States	95403
44	Kaiser Permanente Medical Center - South San Francisco	South San Francisco	California	United States	94080
45	Kaiser Permanente Medical Facility - Stockton	Stockton	California	United States	95210
46	Tahoe Forest Cancer Center	Truckee	California	United States	96161
47	Kaiser Permanente Medical Center - Vacaville	Vacaville	California	United States	95688
48	Kaiser Permanente Medical Center - Vallejo	Vallejo	California	United States	94589
49	Sutter Solano Medical Center	Vallejo	California	United States	94589
50	Kaiser Permanente Medical Center - Walnut Creek	Walnut Creek	California	United States	94596
51	San Luis Valley Regional Medical Center	Alamosa	Colorado	United States	81101
52	University of Colorado Cancer Center at UC Health Sciences Center	Aurora	Colorado	United States	80045
53	Denver Health Medical Center	Denver	Colorado	United States	80204
54	Kaiser Permanente - Denver	Denver	Colorado	United States	80205
55	Shaw Regional Cancer Center	Edwards	Colorado	United States	81632
56	Poudre Valley Hospital	Fort Collins	Colorado	United States	80524
57	Valley View Hospital Cancer Center	Glenwood Springs	Colorado	United States	81601
58	St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center	Grand Junction	Colorado	United States	81502
59	Kaiser Permanente - Lafayette	Lafayette	Colorado	United States	80026
60	Montrose Memorial Hospital Cancer Center	Montrose	Colorado	United States	81401
61	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut	United States	06105
62	Piedmont Hospital	Atlanta	Georgia	United States	30309
63	Northside Hospital Cancer Center	Atlanta	Georgia	United States	30342-1611
64	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia	United States	30342-1701
65	CCOP - Atlanta Regional	Atlanta	Georgia	United States	30342
66	WellStar Cobb Hospital	Austell	Georgia	United States	30106
67	John B. Amos Cancer Center	Columbus	Georgia	United States	31904
68	Charles B. Eberhart Cancer Center at DeKalb Medical Center	Decatur	Georgia	United States	30033
69	Northeast Georgia Medical Center	Gainesville	Georgia	United States	30501
70	Gwinnett Medical Center	Lawrenceville	Georgia	United States	30045
71	Kennestone Cancer Center at Wellstar Kennestone Hospital	Marietta	Georgia	United States	30060
72	Southern Regional Medical Center	Riverdale	Georgia	United States	30274-2600
73	Harbin Clinic Cancer Center - Medical Oncology	Rome	Georgia	United States	30165
74	Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler	Savannah	Georgia	United States	31405
75	Pearlman Comprehensive Cancer Center at South Georgia Medical Center	Valdosta	Georgia	United States	31603
76	Kapiolani Medical Center at Pali Momi	'Aiea	Hawaii	United States	96701
77	Cancer Research Center of Hawaii	Honolulu	Hawaii	United States	96813
78	OnCare Hawaii, Incorporated - Lusitana	Honolulu	Hawaii	United States	96813
79	Queen's Cancer Institute at Queen's Medical Center	Honolulu	Hawaii	United States	96813
80	Straub Clinic and Hospital, Incorporated	Honolulu	Hawaii	United States	96813
81	Hawaii Medical Center - East	Honolulu	Hawaii	United States	96817
82	OnCare Hawaii, Incorporated - Kuakini	Honolulu	Hawaii	United States	96817
83	Kaiser Permanente - Moanalua Medical Center and Clinic	Honolulu	Hawaii	United States	96819
84	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	United States	96826
85	Tripler Army Medical Center	Honolulu	Hawaii	United States	96859
86	Pacific Cancer Institute - Maui	Wailuku	Hawaii	United States	96793
87	Saint Anthony's Hospital at Saint Anthony's Health Center	Alton	Illinois	United States	62002
88	Cancer Care Center of Decatur	Decatur	Illinois	United States	62526
89	Decatur Memorial Hospital Cancer Care Institute	Decatur	Illinois	United States	62526
90	Crossroads Cancer Center	Effingham	Illinois	United States	62401
91	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois	United States	60153
92	Good Samaritan Regional Health Center	Mount Vernon	Illinois	United States	62864
93	Edward Hospital Cancer Center	Naperville	Illinois	United States	60540
94	Regional Cancer Center at Memorial Medical Center	Springfield	Illinois	United States	62781-0001
95	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana	United States	46107
96	Reid Hospital & Health Care Services	Richmond	Indiana	United States	47374
97	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa	United States	52803
98	Genesis Medical Center - West Campus	Davenport	Iowa	United States	52804
99	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas	United States	66720
100	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
101	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas	United States	67042
102	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas	United States	66701
103	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
104	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas	United States	67068
105	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
106	Cancer Center of Kansas, PA - Liberal	Liberal	Kansas	United States	67905
107	Cancer Center of Kansas, PA - Newton	Newton	Kansas	United States	67114
108	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas	United States	67357
109	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas	United States	67124
110	Cancer Center of Kansas, PA - Salina	Salina	Kansas	United States	67401
111	Cotton-O'Neil Cancer Center	Topeka	Kansas	United States	66606
112	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas	United States	67152
113	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas	United States	67208
114	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas	United States	67214
115	CCOP - Wichita	Wichita	Kansas	United States	67214
116	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
117	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas	United States	67156
118	Cancer Care at Our Lady of Bellefonte Hospital	Ashland	Kentucky	United States	41101
119	Northeast Louisiana Cancer Institute at St. Francis Medical Center	Alexandria	Louisiana	United States	71301
120	Tulane Cancer Center Office of Clinical Research	Alexandria	Louisiana	United States	71315-3198
121	Mary Bird Perkins Cancer Center - Baton Rouge	Baton Rouge	Louisiana	United States	70809
122	Louisiana State University Health Sciences Center - Monroe	Monroe	Louisiana	United States	71210
123	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
124	Medical Center of Louisiana - New Orleans	New Orleans	Louisiana	United States	70112
125	Feist-Weiller Cancer Center at Louisiana State University Health Sciences	Shreveport	Louisiana	United States	71130-3932
126	Alvin and Lois Lapidus Cancer Institute at Sinai Hospital	Baltimore	Maryland	United States	21215
127	Boston University Cancer Research Center	Boston	Massachusetts	United States	02118
128	Caritas St. Elizabeth's Medical Center	Brighton	Massachusetts	United States	02135-2997
129	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
130	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
131	Battle Creek Health System Cancer Care Center	Battle Creek	Michigan	United States	49017
132	Bay Regional Medical Center	Bay City	Michigan	United States	48708
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	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan	United States	48202
136	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
137	Hurley Medical Center	Flint	Michigan	United States	48503
138	Great Lakes Cancer Institute at McLaren Regional Medical Center	Flint	Michigan	United States	48532
139	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan	United States	49503
140	CCOP - Grand Rapids	Grand Rapids	Michigan	United States	49503
141	Lacks Cancer Center at Saint Mary's Health Care	Grand Rapids	Michigan	United States	49503
142	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
143	Foote Memorial Hospital	Jackson	Michigan	United States	49201
144	Breslin Cancer Center at Ingham Regional Medical Center	Lansing	Michigan	United States	48910
145	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
146	Lapeer Regional Hospital	Lapeer	Michigan	United States	48446
147	St. Mary Mercy Hospital	Livonia	Michigan	United States	48154
148	MidMichigan Medical Center - Midland	Midland	Michigan	United States	48670
149	Mercy General Health Partners	Muskegon	Michigan	United States	49443
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	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan	United States	48073
153	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
154	Providence Cancer Institute at Providence Hospital - Southfield Campus	Southfield	Michigan	United States	48075
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	University of Mississippi Cancer Clinic	Jackson	Mississippi	United States	39216
159	Regional Cancer Center at Singing River Hospital	Pascagoula	Mississippi	United States	39581
160	Skaggs Cancer Center at Skaggs Regional Medical Center	Branson	Missouri	United States	65616
161	Saint Francis Medical Center	Cape Girardeau	Missouri	United States	63703
162	Midwest Hematology Oncology Group, Incorporated	Saint Louis	Missouri	United States	63109
163	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri	United States	63141
164	David C. Pratt Cancer Center at St. John's Mercy	Saint Louis	Missouri	United States	63141
165	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65802
166	St. John's Regional Health Center	Springfield	Missouri	United States	65804
167	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
168	CCOP - Montana Cancer Consortium	Billings	Montana	United States	59101
169	Northern Rockies Radiation Oncology Center	Billings	Montana	United States	59101
170	St. Vincent Healthcare Cancer Care Services	Billings	Montana	United States	59101
171	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana	United States	59102
172	Billings Clinic - Downtown	Billings	Montana	United States	59107-7000
173	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
174	St. James Healthcare Cancer Care	Butte	Montana	United States	59701
175	Big Sky Oncology	Great Falls	Montana	United States	59405-5309
176	Great Falls Clinic - Main Facility	Great Falls	Montana	United States	59405
177	Sletten Cancer Institute at Benefis Healthcare	Great Falls	Montana	United States	59405
178		Great Falls	Montana	United States	59405
179	Northern Montana Hospital	Havre	Montana	United States	59501
180	St. Peter's Hospital	Helena	Montana	United States	59601
181	Glacier Oncology, PLLC	Kalispell	Montana	United States	59901
182	Kalispell Medical Oncology at KRMC	Kalispell	Montana	United States	59901
183	Guardian Oncology and Center for Wellness	Missoula	Montana	United States	59804
184	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana	United States	59807-7877
185	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana	United States	59807
186	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
187	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
188	Lovelace Medical Center - Downtown	Albuquerque	New Mexico	United States	87102
189	Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital	Albuquerque	New Mexico	United States	87110
190	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87131-5636
191	University of New Mexico Cancer Center - South	Las Cruces	New Mexico	United States	88011
192	Tucker Center for Cancer Care at Orange Regional Medical Center	Middletown	New York	United States	10940-4199
193	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	New York	New York	United States	10032
194	CaroMont Cancer Center at Gaston Memorial Hospital	Gastonia	North Carolina	United States	28053
195	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
196	Pardee Memorial Hospital	Hendersonville	North Carolina	United States	28791
197	High Point Regional Hospital	High Point	North Carolina	United States	27261
198	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
199	Iredell Memorial Hospital	Statesville	North Carolina	United States	28677
200	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio	United States	44307
201	Cleveland Clinic Beachwood Family Health and Surgery Center	Beachwood	Ohio	United States	44122
202	Mary Rutan Hospital	Bellefontaine	Ohio	United States	43311
203	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
204	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio	United States	45267
205	Cleveland Clinic Cancer Center at Fairview Hospital	Cleveland	Ohio	United States	44111
206	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
207	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
208	CCOP - Columbus	Columbus	Ohio	United States	43215
209	Grant Medical Center Cancer Care	Columbus	Ohio	United States	43215
210	Mount Carmel Health - West Hospital	Columbus	Ohio	United States	43222
211	Doctors Hospital at Ohio Health	Columbus	Ohio	United States	43228
212	Grandview Hospital	Dayton	Ohio	United States	45405
213	Good Samaritan Hospital	Dayton	Ohio	United States	45406
214	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio	United States	45409
215	Samaritan North Cancer Care Center	Dayton	Ohio	United States	45415
216	CCOP - Dayton	Dayton	Ohio	United States	45420
217	Grady Memorial Hospital	Delaware	Ohio	United States	43015
218	Blanchard Valley Medical Associates	Findlay	Ohio	United States	45840
219	Middletown Regional Hospital	Franklin	Ohio	United States	45005-1066
220	Wayne Hospital	Greenville	Ohio	United States	45331
221	Cleveland Clinic Cancer Center	Independence	Ohio	United States	44131
222	Charles F. Kettering Memorial Hospital	Kettering	Ohio	United States	45429
223	Fairfield Medical Center	Lancaster	Ohio	United States	43130
224	MedCentral - Mansfield Hospital	Mansfield	Ohio	United States	44903
225	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio	United States	45750
226	Hillcrest Cancer Center at Hillcrest Hospital	Mayfield Heights	Ohio	United States	44124
227	Knox Community Hospital	Mount Vernon	Ohio	United States	43050
228	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio	United States	43055
229	Community Hospital of Springfield and Clark County	Springfield	Ohio	United States	45505
230	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio	United States	45373-1300
231	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio	United States	43081
232	Clinton Memorial Hospital	Wilmington	Ohio	United States	45177
233	Cleveland Clinic - Wooster	Wooster	Ohio	United States	44691
234	United States Air Force Medical Center - Wright-Patterson	Wright-Patterson Air Force Base	Ohio	United States	45433-5529
235	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio	United States	45385
236	Genesis - Good Samaritan Hospital	Zanesville	Ohio	United States	43701
237	St. Charles Medical Center - Bend	Bend	Oregon	United States	97701
238	Bay Area Hospital	Coos Bay	Oregon	United States	97420
239	Legacy Mount Hood Medical Center	Gresham	Oregon	United States	97030
240	Providence Milwaukie Hospital	Milwaukie	Oregon	United States	97222
241	Legacy Good Samaritan Hospital & Comprehensive Cancer Center	Portland	Oregon	United States	97210
242	Providence Cancer Center at Providence Portland Medical Center	Portland	Oregon	United States	97213-2967
243	Adventist Medical Center	Portland	Oregon	United States	97216
244	CCOP - Columbia River Oncology Program	Portland	Oregon	United States	97225
245	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
246	Kaiser Permanente Health Care - Portland	Portland	Oregon	United States	97227
247	Legacy Emanuel Hospital and Health Center and Children's Hospital	Portland	Oregon	United States	97227
248	Northwest Cancer Specialists at Rose Quarter Cancer Center	Portland	Oregon	United States	97227
249	Salem Hospital Regional Cancer Care Services	Salem	Oregon	United States	97309-5014
250	Legacy Meridian Park Hospital	Tualatin	Oregon	United States	97062
251	AnMed Cancer Center	Anderson	South Carolina	United States	29621
252	Cancer Centers of the Carolinas - Easley	Easley	South Carolina	United States	29640
253	Bon Secours St. Francis Health System	Greenville	South Carolina	United States	29601
254	Cancer Centers of the Carolinas - Faris Road	Greenville	South Carolina	United States	29605
255	Cancer Centers of the Carolinas - Grove Commons	Greenville	South Carolina	United States	29605
256	Greenville Hospital Cancer Center	Greenville	South Carolina	United States	29605
257	CCOP - Greenville	Greenville	South Carolina	United States	29615
258	Self Regional Cancer Center at Self Regional Medical Center	Greenwood	South Carolina	United States	29646
259	Cancer Centers of the Carolinas - Greer Medical Oncology	Greer	South Carolina	United States	29650
260	Cancer Centers of the Carolinas - Seneca	Seneca	South Carolina	United States	29672
261	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
262	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
263	Cancer Centers of the Carolinas - Spartanburg	Spartanburg	South Carolina	United States	29307
264	St. Joseph Cancer Center	Bellingham	Washington	United States	98225
265	Olympic Hematology and Oncology	Bremerton	Washington	United States	98310
266	Providence Centralia Hospital	Centralia	Washington	United States	98531-9027
267	St. Francis Hospital	Federal Way	Washington	United States	98003
268	Columbia Basin Hematology	Kennewick	Washington	United States	99336
269	Cascade Cancer Center at Evergreen Hospital Medical Center	Kirkland	Washington	United States	98033
270	Skagit Valley Hospital Cancer Care Center	Mount Vernon	Washington	United States	98273
271	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington	United States	98506-5166
272	Harrison Poulsbo Hematology and Onocology	Poulsbo	Washington	United States	98370
273	Good Samaritan Cancer Center	Puyallup	Washington	United States	98372
274	CCOP - Virginia Mason Research Center	Seattle	Washington	United States	98101
275	Harborview Medical Center	Seattle	Washington	United States	98104
276	Minor and James Medical, PLLC	Seattle	Washington	United States	98104
277	Pacific Medical Center	Seattle	Washington	United States	98104
278	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109
279	Group Health Central Hospital	Seattle	Washington	United States	98112
280	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	Seattle	Washington	United States	98122-4307
281	Polyclinic First Hill	Seattle	Washington	United States	98122
282	University Cancer Center at University of Washington Medical Center	Seattle	Washington	United States	98195
283	Cancer Care Northwest - Spokane South	Spokane	Washington	United States	99202
284	Evergreen Hematology and Oncology, PS	Spokane	Washington	United States	99218
285	Franciscan Cancer Center at St. Joseph Medical Center	Tacoma	Washington	United States	98405-3004
286	Allenmore Hospital	Tacoma	Washington	United States	98405
287	CCOP - Northwest	Tacoma	Washington	United States	98405
288	MultiCare Regional Cancer Center at Tacoma General Hospital	Tacoma	Washington	United States	98405
289	St. Clare Hospital	Tacoma	Washington	United States	98499
290	Southwest Washington Medical Center Cancer Center	Vancouver	Washington	United States	98668
291	Legacy Salmon Creek Medical Center	Vancouver	Washington	United States	98686
292	Wenatchee Valley Medical Center	Wenatchee	Washington	United States	98801-2028
293	North Star Lodge Cancer Center at Yakima Valley Memorial Hospital	Yakima	Washington	United States	98902
294	Rocky Mountain Oncology	Casper	Wyoming	United States	82609
295	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming	United States	82801

Sponsors and Collaborators

• Southwest Oncology Group
• National Cancer Institute (NCI)

Investigators

• 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: NCT00775645
• Other Study ID Numbers: CDR0000617081; S0715; U10CA037429
• First Posted: Oct 20, 2008
• Last Update Posted: Aug 14, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Southwest Oncology Group: neurotoxicity; chemotherapeutic agent toxicity; fatigue; neuropathy; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer
• Additional relevant MeSH terms: Breast Neoplasms; Peripheral Nervous System Diseases; Neurotoxicity Syndromes; Fatigue; Acetylcarnitine

Study Results

Participant Flow

Pre-assignment Detail	Of the 437 accrued patients, 27 were ineligible and 1 withdrew consent.

Arm/Group Title	Arm I (Acetyl-L-carnitine Hydrochloride))	Arm II (Placebo)
Arm/Group Description	Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks	Patients receive oral placebo 3 times daily for 24 weeks
Period Title: Overall Study
STARTED	208	201
COMPLETED	191	181
NOT COMPLETED	17	20

Baseline Characteristics

Arm/Group Title	Arm I (Acetyl-L-carnitine Hydrochloride))	Arm II (Placebo)	Total
Arm/Group Description	Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks	Patients receive oral placebo 3 times daily for 24 weeks	Total of all reporting groups
Overall Participants	208	201	409
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	52	50	52
Sex: Female, Male (Count of Participants)
Female	208 100%	201 100%	409 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	21 10.1%	15 7.5%	36 8.8%
Not Hispanic or Latino	181 87%	177 88.1%	358 87.5%
Unknown or Not Reported	6 2.9%	9 4.5%	15 3.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.5%	0 0%	1 0.2%
Asian	12 5.8%	8 4%	20 4.9%
Native Hawaiian or Other Pacific Islander	4 1.9%	2 1%	6 1.5%
Black or African American	17 8.2%	20 10%	37 9%
White	160 76.9%	165 82.1%	325 79.5%
More than one race	2 1%	1 0.5%	3 0.7%
Unknown or Not Reported	12 5.8%	5 2.5%	17 4.2%
Zubrod Performance Status (Count of Participants)
0	156 75%	146 72.6%	302 73.8%
1	51 24.5%	54 26.9%	105 25.7%
2	1 0.5%	1 0.5%	2 0.5%
Breast cancer stage (Count of Participants)
I	57 27.4%	50 24.9%	107 26.2%
II	110 52.9%	107 53.2%	217 53.1%
III	41 19.7%	43 21.4%	84 20.5%
Not measurable/measured	0 0%	1 0.5%	1 0.2%
Taxane regiment (Count of Participants)
Paclitaxel	124 59.6%	123 61.2%	247 60.4%
Docetaxel	84 40.4%	77 38.3%	161 39.4%
Not measurable/measured	0 0%	1 0.5%	1 0.2%

Outcome Measures

1. Primary Outcome

Title	12-week FACT-Taxane Neurotoxicity Model-adjusted Score in ALC and Placebo Groups
Description	Compare whether treatment with acetyl-L-carnitine hydrochloride vs placebo prevents symptoms of neuropathy as measured by the 11-item neurotoxicity (NTX) component of the Functional Assesment of Cancer Therapy (FACT)-Taxane Questionnaire at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate worse CIPN. Total possible range is 0 to 64. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires
Time Frame	12 weeks post-registration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Acetyl-L-carnitine Hydrochloride))	Arm II (Placebo)
Arm/Group Description	Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks	Patients receive oral placebo 3 times daily for 24 weeks
Measure Participants	191	181
Mean (Full Range) [units on a scale]	35.4	36.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Acetyl-L-carnitine Hydrochloride)), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.17
	Comments
	Method	Regression, Linear
	Comments	Linear regression model adjusted for baseline score, taxane regiment, and age.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.9
	Confidence Interval	(2-Sided) 95%; -2.2 to 0.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	12-week FACT-Trial Outcome Index(TOI) Functional Status Model-adjusted Score in ALC and Placebo Groups
Description	Compare FACT-TOI outcome in treatment vs placebo groups at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate worse functional status. Total possible range is 0 to 120. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires
Time Frame	12 weeks post-registration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Acetyl-L-carnitine Hydrochloride))	Arm II (Placebo)
Arm/Group Description	Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks	Patients receive oral placebo 3 times daily for 24 weeks
Measure Participants	191	181
Mean (Full Range) [units on a scale]	92.1	92.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Acetyl-L-carnitine Hydrochloride)), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.92
	Comments
	Method	Regression, Linear
	Comments	Linear regression model adjusted for baseline score, taxane regiment, and age.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95%; -3 to 2.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	12-week FACIT-fatigue Model-adjusted Score in ALC and Placebo Groups
Description	Compare fatigue outcome between treatment and placebo groups as measured by the 13-item Functional Assessment of Chronic Illness Therapy FACIT-fatigue questionnaire at 12 weeks after study registration in women with breast cancer undergoing adjuvant taxane-based chemotherapy. Linear regression model adjusted for baseline score, taxane regiment, and age. Lower scores indicate more fatigue. Total possible range is 0 to 52. For more information on this subscale, please see http://www.facit.org/FACITOrg/Questionnaires
Time Frame	12 weeks post-registration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Acetyl-L-carnitine Hydrochloride))	Arm II (Placebo)
Arm/Group Description	Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks	Patients receive oral placebo 3 times daily for 24 weeks
Measure Participants	191	181
Mean (Full Range) [FACIT-fatigue score]	36.6	35.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Acetyl-L-carnitine Hydrochloride)), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.20
	Comments
	Method	Regression, Linear
	Comments	Linear regression model adjusted for baseline score, taxane regiment, and age.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -0.7 to 3.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Other Pre-specified Outcome

Title	Proportion of Patients Experiencing Grade 3 or 4 Neuropathy
Description	Proportion of patients experiencing grade 3 or 4 neuropathy
Time Frame	12 weeks post-registration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm I (Acetyl-L-carnitine Hydrochloride))	Arm II (Placebo)
Arm/Group Description	Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks	Patients receive oral placebo 3 times daily for 24 weeks
Measure Participants	202	194
Count of Participants [Participants]	8 3.8%	1 0.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Acetyl-L-carnitine Hydrochloride)), Arm II (Placebo)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.46
	Comments
	Method	Regression, Linear
	Comments	Adjusted for randomization stratification factors.

5. Other Pre-specified Outcome

Title	Serum Nerve Growth Factor Levels
Time Frame	12 weeks post-registration

Outcome Measure Data

Analysis Population Description

Data still in process; Analysis to be performed in future.

Arm/Group Title	Arm I (Acetyl-L-carnitine Hydrochloride))	Arm II (Placebo)
Arm/Group Description	Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks	Patients receive oral placebo 3 times daily for 24 weeks
Measure Participants	0	0

6. Other Pre-specified Outcome

Title	Treatment and Concurrent Therapy
Description	total dose of taxane received and treatment delays, compliance with therapy, and use of concurrent medications, dietary supplements (e.g., glutamine), vitamin E, and complementary and alternative medicines
Time Frame	12 weeks post-registration

Outcome Measure Data

Analysis Population Description

Data still in process; Analysis to be performed in future.

Arm/Group Title	Arm I (Acetyl-L-carnitine Hydrochloride))	Arm II (Placebo)
Arm/Group Description	Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks	Patients receive oral placebo 3 times daily for 24 weeks
Measure Participants	0	0

7. Other Pre-specified Outcome

Title	Association Between Nerve Growth Factor Levels and the Degree of Neuropathy and Functional Status
Description	Explore the relationship between nerve growth factor levels and the degree of neuropathy and functional status in these patients.
Time Frame	12 weeks post-registration

Outcome Measure Data

Analysis Population Description

Data still in process; Analysis to be performed in future.

Arm/Group Title	Arm I (Acetyl-L-carnitine Hydrochloride))	Arm II (Placebo)
Arm/Group Description	Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks	Patients receive oral placebo 3 times daily for 24 weeks
Measure Participants	0	0

8. Other Pre-specified Outcome

Title	Association Between Genetic Markers Responsible for Taxane Metabolism and Clearance and the Degree of Neuropathy
Description	Explore the relationship between genetic markers responsible for taxane metabolism and clearance (e.g., CYP2C8, CYP3A4, CYP3A5, GSTM1, and GSTP1) and the degree of neuropathy in these patients.
Time Frame	12 weeks post-registration

Outcome Measure Data

Analysis Population Description

Data still in process; Analysis to be performed in future.

Arm/Group Title	Arm I (Acetyl-L-carnitine Hydrochloride))	Arm II (Placebo)
Arm/Group Description	Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks	Patients receive oral placebo 3 times daily for 24 weeks
Measure Participants	0	0

Adverse Events

Time Frame	Up to 25 weeks
Arm/Group Title	Arm I (Acetyl-L-carnitine Hydrochloride))		Arm II (Placebo)
Arm/Group Description	Patients receive oral acetyl-L-carnitine hydrochloride 3 times daily for 24 weeks		Patients receive oral placebo 3 times daily for 24 weeks
All Cause Mortality
	Arm I (Acetyl-L-carnitine Hydrochloride))		Arm II (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm I (Acetyl-L-carnitine Hydrochloride))		Arm II (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/208 (0.5%)		0/201 (0%)
Investigations
Neutrophils/granulocytes (ANC/AGC)	1/208 (0.5%)		0/201 (0%)
Other (Not Including Serious) Adverse Events
	Arm I (Acetyl-L-carnitine Hydrochloride))		Arm II (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	156/208 (75%)		153/201 (76.1%)
Gastrointestinal disorders
Diarrhea	13/208 (6.3%)		10/201 (5%)
Nausea	46/208 (22.1%)		51/201 (25.4%)
Vomiting	17/208 (8.2%)		14/201 (7%)
General disorders
Fatigue (asthenia, lethargy, malaise)	38/208 (18.3%)		32/201 (15.9%)
Musculoskeletal and connective tissue disorders
Pain - Joint	13/208 (6.3%)		12/201 (6%)
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness	12/208 (5.8%)		9/201 (4.5%)
Neuropathy: motor	18/208 (8.7%)		16/201 (8%)
Neuropathy: sensory	127/208 (61.1%)		127/201 (63.2%)
Psychiatric disorders
Insomnia	51/208 (24.5%)		45/201 (22.4%)
Vascular disorders
Hot flashes/flushes	21/208 (10.1%)		14/201 (7%)

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.