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

June 29, 2017 updated by: Southwest Oncology Group

S0715: Randomized Placebo-Controlled Trial of Acetyl-L-Carnitine (ALC) for the Prevention of Taxane Induced Neuropathy Phase III

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

437

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Mobile, Alabama, United States, 36608
    - Providence Cancer Center at Providence Hospital
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Providence Cancer Center
  - Anchorage, Alaska, United States, 99508
    - Alaska Regional Hospital Cancer Center
  - Fairbanks, Alaska, United States, 99701
    - Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
- California
  - Antioch, California, United States, 94531
    - Kaiser Permanente - Deer Valley
  - Berkeley, California, United States, 94704
    - Alta Bates Summit Comprehensive Cancer Center
  - Burlingame, California, United States, 94010
    - Peninsula Medical Center
  - Castro Valley, California, United States, 94546
    - East Bay Radiation Oncology Center
  - Castro Valley, California, United States, 94546
    - Eden Medical Center
  - Castro Valley, California, United States, 94546
    - Valley Medical Oncology Consultants - Castro Valley
  - Fremont, California, United States, 94538
    - Kaiser Permanente - Fremont
  - Fremont, California, United States, 94538
    - Valley Medical Oncology
  - Glendale, California, United States, 91204
    - Glendale Memorial Hospital Comprehensive Cancer Center
  - Hayward, California, United States, 94545
    - Kaiser Permanente Medical Center - Hayward
  - Los Angeles, California, United States, 90089-9181
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Martinez, California, United States, 94553-3156
    - Contra Costa Regional Medical Center
  - Marysville, California, United States, 95901
    - Tibotec Therapeutics - Division of Ortho Biotech Products, LP
  - Mountain View, California, United States, 94040
    - El Camino Hospital Cancer Center
  - Oakland, California, United States, 94609
    - Alta Bates Summit Medical Center - Summit Campus
  - Oakland, California, United States, 94602
    - Highland General Hospital
  - Oakland, California, United States, 94609
    - Larry G Strieff MD Medical Corporation
  - Oakland, California, United States, 94609
    - CCOP - Bay Area Tumor Institute
  - Oakland, California, United States, 94609
    - Bay Area Breast Surgeons, Incorporated
  - Oakland, California, United States, 94609
    - Tom K Lee, Incorporated
  - Oakland, California, United States, 94611
    - Kaiser Permanente Medical Center - Oakland
  - Pleasanton, California, United States, 94588
    - Valley Care Medical Center
  - Pleasanton, California, United States, 94588
    - Valley Medical Oncology Consultants - Pleasanton
  - Redwood City, California, United States, 94063
    - Kaiser Permanente Medical Center - Redwood City
  - Richmond, California, United States, 94801
    - Kaiser Permanente Medical Center - Richmond
  - Roseville, California, United States, 95661
    - Kaiser Permanente Medical Center - Roseville
  - Roseville, California, United States, 95661
    - Sutter Cancer Center at Roseville Medical Center
  - Sacramento, California, United States, 95816
    - Sutter Cancer Center
  - Sacramento, California, United States, 95817
    - University of California Davis Cancer Center
  - Sacramento, California, United States, 95823
    - South Sacramento Kaiser-Permanente Medical Center
  - Sacramento, California, United States, 95825
    - Kaiser Permanente Medical Center - Sacramento
  - San Francisco, California, United States, 94115
    - Kaiser Permanente Medical Center - San Francisco Geary Campus
  - San Francisco, California, United States, 94118
    - California Pacific Medical Center - California Campus
  - San Jose, California, United States, 95119
    - Kaiser Permanente Medical Center - Santa Teresa
  - San Pablo, California, United States, 94806
    - Doctors Medical Center - San Pablo Campus
  - San Rafael, California, United States, 94903
    - Sutter Health - Western Division Cancer Research Group
  - San Rafael, California, United States, 94903
    - Kaiser Foundation Hospital - San Rafael
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Medical Center - Santa Clara Kiely Campus
  - Santa Rosa, California, United States, 95403
    - Kaiser Permanente Medical Center - Santa Rosa
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente Medical Center - South San Francisco
  - Stockton, California, United States, 95210
    - Kaiser Permanente Medical Facility - Stockton
  - Truckee, California, United States, 96161
    - Tahoe Forest Cancer Center
  - Vacaville, California, United States, 95688
    - Kaiser Permanente Medical Center - Vacaville
  - Vallejo, California, United States, 94589
    - Sutter Solano Medical Center
  - Vallejo, California, United States, 94589
    - Kaiser Permanente Medical Center - Vallejo
  - Walnut Creek, California, United States, 94596
    - Kaiser Permanente Medical Center - Walnut Creek
- Colorado
  - Alamosa, Colorado, United States, 81101
    - San Luis Valley Regional Medical Center
  - Aurora, Colorado, United States, 80045
    - University of Colorado Cancer Center at UC Health Sciences Center
  - Denver, Colorado, United States, 80204
    - Denver Health Medical Center
  - Denver, Colorado, United States, 80205
    - Kaiser Permanente - Denver
  - Edwards, Colorado, United States, 81632
    - Shaw Regional Cancer Center
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Glenwood Springs, Colorado, United States, 81601
    - Valley View Hospital Cancer Center
  - Grand Junction, Colorado, United States, 81502
    - St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  - Lafayette, Colorado, United States, 80026
    - Kaiser Permanente - Lafayette
  - Montrose, Colorado, United States, 81401
    - Montrose Memorial Hospital Cancer Center
- Connecticut
  - Hartford, Connecticut, United States, 06105
    - Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Georgia
  - Atlanta, Georgia, United States, 30309
    - Piedmont Hospital
  - Atlanta, Georgia, United States, 30342-1611
    - Northside Hospital Cancer Center
  - Atlanta, Georgia, United States, 30342-1701
    - Saint Joseph's Hospital of Atlanta
  - Atlanta, Georgia, United States, 30342
    - CCOP - Atlanta Regional
  - Austell, Georgia, United States, 30106
    - WellStar Cobb Hospital
  - Columbus, Georgia, United States, 31904
    - John B. Amos Cancer Center
  - Decatur, Georgia, United States, 30033
    - Charles B. Eberhart Cancer Center at DeKalb Medical Center
  - Gainesville, Georgia, United States, 30501
    - Northeast Georgia Medical Center
  - Lawrenceville, Georgia, United States, 30045
    - Gwinnett Medical Center
  - Marietta, Georgia, United States, 30060
    - Kennestone Cancer Center at Wellstar Kennestone Hospital
  - Riverdale, Georgia, United States, 30274-2600
    - Southern Regional Medical Center
  - Rome, Georgia, United States, 30165
    - Harbin Clinic Cancer Center - Medical Oncology
  - Savannah, Georgia, United States, 31405
    - Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
  - Valdosta, Georgia, United States, 31603
    - Pearlman Comprehensive Cancer Center at South Georgia Medical Center
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Kapiolani Medical Center at Pali Momi
  - Honolulu, Hawaii, United States, 96813
    - Cancer Research Center of Hawaii
  - Honolulu, Hawaii, United States, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, United States, 96813
    - OnCare Hawaii, Incorporated - Lusitana
  - Honolulu, Hawaii, United States, 96813
    - Queen's Cancer Institute at Queen's Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital, Incorporated
  - Honolulu, Hawaii, United States, 96817
    - Hawaii Medical Center - East
  - Honolulu, Hawaii, United States, 96817
    - OnCare Hawaii, Incorporated - Kuakini
  - Honolulu, Hawaii, United States, 96859
    - Tripler Army Medical Center
  - Honolulu, Hawaii, United States, 96819
    - Kaiser Permanente - Moanalua Medical Center and Clinic
  - Wailuku, Hawaii, United States, 96793
    - Pacific Cancer Institute - Maui
- Illinois
  - Alton, Illinois, United States, 62002
    - Saint Anthony's Hospital at Saint Anthony's Health Center
  - Decatur, Illinois, United States, 62526
    - Cancer Care Center of Decatur
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital Cancer Care Institute
  - Effingham, Illinois, United States, 62401
    - Crossroads Cancer Center
  - Maywood, Illinois, United States, 60153
    - Cardinal Bernardin Cancer Center at Loyola University Medical Center
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - Naperville, Illinois, United States, 60540
    - Edward Hospital Cancer Center
  - Springfield, Illinois, United States, 62781-0001
    - Regional Cancer Center at Memorial Medical Center
- Indiana
  - Beech Grove, Indiana, United States, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Richmond, Indiana, United States, 47374
    - Reid Hospital & Health Care Services
- Iowa
  - Davenport, Iowa, United States, 52804
    - Genesis Medical Center - West Campus
  - Davenport, Iowa, United States, 52803
    - Genesis Regional Cancer Center at Genesis Medical Center
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas, PA - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas, PA - El Dorado
  - Fort Scott, Kansas, United States, 66701
    - Cancer Center of Kansas - Fort Scott
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas-Independence
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas, PA - Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, United States, 67905
    - Cancer Center of Kansas, PA - Liberal
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas, PA - Newton
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas, PA - Salina
  - Topeka, Kansas, United States, 66606
    - Cotton-O'Neil Cancer Center
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas, PA - Wichita
  - Wichita, Kansas, United States, 67214
    - CCOP - Wichita
  - Wichita, Kansas, United States, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas, PA - Winfield
- Kentucky
  - Ashland, Kentucky, United States, 41101
    - Cancer Care at Our Lady of Bellefonte Hospital
- Louisiana
  - Alexandria, Louisiana, United States, 71315-3198
    - Tulane Cancer Center Office of Clinical Research
  - Alexandria, Louisiana, United States, 71301
    - Northeast Louisiana Cancer Institute at St. Francis Medical Center
  - Baton Rouge, Louisiana, United States, 70809
    - Mary Bird Perkins Cancer Center - Baton Rouge
  - Monroe, Louisiana, United States, 71210
    - Louisiana State University Health Sciences Center - Monroe
  - New Orleans, Louisiana, United States, 70112
    - MBCCOP - LSU Health Sciences Center
  - New Orleans, Louisiana, United States, 70112
    - Medical Center of Louisiana - New Orleans
  - Shreveport, Louisiana, United States, 71130-3932
    - Feist-Weiller Cancer Center at Louisiana State University Health Sciences
- Maryland
  - Baltimore, Maryland, United States, 21215
    - Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
- Massachusetts
  - Boston, Massachusetts, United States, 02118
    - Boston University Cancer Research Center
  - Brighton, Massachusetts, United States, 02135-2997
    - Caritas St. Elizabeth's Medical Center
- Michigan
  - Ann Arbor, Michigan, United States, 48106-0995
    - Saint Joseph Mercy Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Battle Creek, Michigan, United States, 49017
    - Battle Creek Health System Cancer Care Center
  - Bay City, Michigan, United States, 48708
    - Bay Regional Medical Center
  - Big Rapids, Michigan, United States, 49307
    - Mecosta County Medical Center
  - Dearborn, Michigan, United States, 48123-2500
    - Oakwood Cancer Center at Oakwood Hospital and Medical Center
  - Detroit, Michigan, United States, 48202
    - Josephine Ford Cancer Center at Henry Ford Hospital
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Flint, Michigan, United States, 48532
    - Great Lakes Cancer Institute at McLaren Regional Medical Center
  - Grand Rapids, Michigan, United States, 49503
    - Butterworth Hospital at Spectrum Health
  - Grand Rapids, Michigan, United States, 49503
    - CCOP - Grand Rapids
  - Grand Rapids, Michigan, United States, 49503
    - Lacks Cancer Center at Saint Mary's Health Care
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Jackson, Michigan, United States, 49201
    - Foote Memorial Hospital
  - Lansing, Michigan, United States, 48912-1811
    - Sparrow Regional Cancer Center
  - Lansing, Michigan, United States, 48910
    - Breslin Cancer Center at Ingham Regional Medical Center
  - Lapeer, Michigan, United States, 48446
    - Lapeer Regional Hospital
  - Livonia, Michigan, United States, 48154
    - St. Mary Mercy Hospital
  - Midland, Michigan, United States, 48670
    - MidMichigan Medical Center - Midland
  - Muskegon, Michigan, United States, 49443
    - Mercy General Health Partners
  - Pontiac, Michigan, United States, 48341-2985
    - St. Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Mercy Regional Cancer Center at Mercy Hospital
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital - Royal Oak Campus
  - Saginaw, Michigan, United States, 48601
    - Seton Cancer Institute at Saint Mary's - Saginaw
  - Southfield, Michigan, United States, 48075
    - Providence Cancer Institute at Providence Hospital - Southfield Campus
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - Warren, Michigan, United States, 48093
    - St. John Macomb Hospital
  - Wyoming, Michigan, United States, 49519
    - Metro Health Hospital
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - University of Mississippi Cancer Clinic
  - Pascagoula, Mississippi, United States, 39581
    - Regional Cancer Center at Singing River Hospital
- Missouri
  - Branson, Missouri, United States, 65616
    - Skaggs Cancer Center at Skaggs Regional Medical Center
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Saint Louis, Missouri, United States, 63141
    - CCOP - St. Louis-Cape Girardeau
  - Saint Louis, Missouri, United States, 63109
    - Midwest Hematology Oncology Group, Incorporated
  - Saint Louis, Missouri, United States, 63141
    - David C. Pratt Cancer Center at St. John's Mercy
  - Springfield, Missouri, United States, 65802
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, United States, 65804
    - St. John's Regional Health Center
  - Springfield, Missouri, United States, 65807
    - Hulston Cancer Center at Cox Medical Center South
- Montana
  - Billings, Montana, United States, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, United States, 59101
    - Northern Rockies Radiation Oncology Center
  - Billings, Montana, United States, 59101
    - St. Vincent Healthcare Cancer Care Services
  - Billings, Montana, United States, 59107-7000
    - Billings Clinic - Downtown
  - Billings, Montana, United States, 59102
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Cancer Center
  - Butte, Montana, United States, 59701
    - St. James Healthcare Cancer Care
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic - Main Facility
  - Great Falls, Montana, United States, 59405
  - Great Falls, Montana, United States, 59405-5309
    - Big Sky Oncology
  - Great Falls, Montana, United States, 59405
    - Sletten Cancer Institute at Benefis Healthcare
  - Havre, Montana, United States, 59501
    - Northern Montana Hospital
  - Helena, Montana, United States, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, United States, 59901
    - Glacier Oncology, PLLC
  - Kalispell, Montana, United States, 59901
    - Kalispell Medical Oncology at KRMC
  - Missoula, Montana, United States, 59804
    - Guardian Oncology and Center for Wellness
  - Missoula, Montana, United States, 59807-7877
    - Montana Cancer Specialists at Montana Cancer Center
  - Missoula, Montana, United States, 59807
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89106
    - CCOP - Nevada Cancer Research Foundation
- New Mexico
  - Albuquerque, New Mexico, United States, 87131-5636
    - University of New Mexico Cancer Center
  - Albuquerque, New Mexico, United States, 87102
    - Lovelace Medical Center - Downtown
  - Albuquerque, New Mexico, United States, 87110
    - Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
  - Las Cruces, New Mexico, United States, 88011
    - University of New Mexico Cancer Center - South
- New York
  - Middletown, New York, United States, 10940-4199
    - Tucker Center for Cancer Care at Orange Regional Medical Center
  - New York, New York, United States, 10032
    - Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
- North Carolina
  - Gastonia, North Carolina, United States, 28053
    - CaroMont Cancer Center at Gaston Memorial Hospital
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital, Incorporated
  - Hendersonville, North Carolina, United States, 28791
    - Pardee Memorial Hospital
  - High Point, North Carolina, United States, 27261
    - High Point Regional Hospital
  - Rutherfordton, North Carolina, United States, 28139
    - Rutherford Hospital
  - Statesville, North Carolina, United States, 28677
    - Iredell Memorial Hospital
- Ohio
  - Akron, Ohio, United States, 44307
    - McDowell Cancer Center at Akron General Medical Center
  - Beachwood, Ohio, United States, 44122
    - Cleveland Clinic Beachwood Family Health and Surgery Center
  - Bellefontaine, Ohio, United States, 43311
    - Mary Rutan Hospital
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cincinnati, Ohio, United States, 45267
    - Charles M. Barrett Cancer Center at University Hospital
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Cleveland, Ohio, United States, 44111
    - Cleveland Clinic Cancer Center at Fairview Hospital
  - Columbus, Ohio, United States, 43214-3998
    - Riverside Methodist Hospital Cancer Care
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health - West Hospital
  - Columbus, Ohio, United States, 43215
    - CCOP - Columbus
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center Cancer Care
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital at Ohio Health
  - Dayton, Ohio, United States, 45405
    - Grandview Hospital
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, United States, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, United States, 45420
    - CCOP - Dayton
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Medical Associates
  - Franklin, Ohio, United States, 45005-1066
    - Middletown Regional Hospital
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Independence, Ohio, United States, 44131
    - Cleveland Clinic Cancer Center
  - Kettering, Ohio, United States, 45429
    - Charles F. Kettering Memorial Hospital
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Mansfield, Ohio, United States, 44903
    - MedCentral - Mansfield Hospital
  - Marietta, Ohio, United States, 45750
    - Strecker Cancer Center at Marietta Memorial Hospital
  - Mayfield Heights, Ohio, United States, 44124
    - Hillcrest Cancer Center at Hillcrest Hospital
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Cancer Care Program at Licking Memorial Hospital
  - Springfield, Ohio, United States, 45505
    - Community Hospital of Springfield and Clark County
  - Troy, Ohio, United States, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Westerville, Ohio, United States, 43081
    - Mount Carmel St. Ann's Cancer Center
  - Wilmington, Ohio, United States, 45177
    - Clinton Memorial Hospital
  - Wooster, Ohio, United States, 44691
    - Cleveland Clinic - Wooster
  - Wright-Patterson Air Force Base, Ohio, United States, 45433-5529
    - United States Air Force Medical Center - Wright-Patterson
  - Xenia, Ohio, United States, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis - Good Samaritan Hospital
- Oregon
  - Bend, Oregon, United States, 97701
    - St. Charles Medical Center - Bend
  - Coos Bay, Oregon, United States, 97420
    - Bay Area Hospital
  - Gresham, Oregon, United States, 97030
    - Legacy Mount Hood Medical Center
  - Milwaukie, Oregon, United States, 97222
    - Providence Milwaukie Hospital
  - Portland, Oregon, United States, 97216
    - Adventist Medical Center
  - Portland, Oregon, United States, 97227
    - Northwest Cancer Specialists at Rose Quarter Cancer Center
  - Portland, Oregon, United States, 97210
    - Legacy Good Samaritan Hospital & Comprehensive Cancer Center
  - Portland, Oregon, United States, 97213-2967
    - Providence Cancer Center at Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - CCOP - Columbia River Oncology Program
  - Portland, Oregon, United States, 97225
    - Providence St. Vincent Medical Center
  - Portland, Oregon, United States, 97227
    - Legacy Emanuel Hospital and Health Center and Children's Hospital
  - Portland, Oregon, United States, 97227
    - Kaiser Permanente Health Care - Portland
  - Salem, Oregon, United States, 97309-5014
    - Salem Hospital Regional Cancer Care Services
  - Tualatin, Oregon, United States, 97062
    - Legacy Meridian Park Hospital
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Cancer Center
  - Easley, South Carolina, United States, 29640
    - Cancer Centers of the Carolinas - Easley
  - Greenville, South Carolina, United States, 29615
    - CCOP - Greenville
  - Greenville, South Carolina, United States, 29605
    - Greenville Hospital Cancer Center
  - Greenville, South Carolina, United States, 29605
    - Cancer Centers of the Carolinas - Faris Road
  - Greenville, South Carolina, United States, 29605
    - Cancer Centers of the Carolinas - Grove Commons
  - Greenville, South Carolina, United States, 29601
    - Bon Secours St. Francis Health System
  - Greenwood, South Carolina, United States, 29646
    - Self Regional Cancer Center at Self Regional Medical Center
  - Greer, South Carolina, United States, 29650
    - Cancer Centers of the Carolinas - Greer Medical Oncology
  - Seneca, South Carolina, United States, 29672
    - Cancer Centers of the Carolinas - Seneca
  - Spartanburg, South Carolina, United States, 29303
    - CCOP - Upstate Carolina
  - Spartanburg, South Carolina, United States, 29303
    - Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
  - Spartanburg, South Carolina, United States, 29307
    - Cancer Centers of the Carolinas - Spartanburg
- Washington
  - Bellingham, Washington, United States, 98225
    - St. Joseph Cancer Center
  - Bremerton, Washington, United States, 98310
    - Olympic Hematology and Oncology
  - Centralia, Washington, United States, 98531-9027
    - Providence Centralia Hospital
  - Federal Way, Washington, United States, 98003
    - St. Francis Hospital
  - Kennewick, Washington, United States, 99336
    - Columbia Basin Hematology
  - Kirkland, Washington, United States, 98033
    - Cascade Cancer Center at Evergreen Hospital Medical Center
  - Mount Vernon, Washington, United States, 98273
    - Skagit Valley Hospital Cancer Care Center
  - Olympia, Washington, United States, 98506-5166
    - Providence St. Peter Hospital Regional Cancer Center
  - Poulsbo, Washington, United States, 98370
    - Harrison Poulsbo Hematology and Onocology
  - Puyallup, Washington, United States, 98372
    - Good Samaritan Cancer Center
  - Seattle, Washington, United States, 98109
    - Fred Hutchinson Cancer Research Center
  - Seattle, Washington, United States, 98104
    - Harborview Medical Center
  - Seattle, Washington, United States, 98101
    - CCOP - Virginia Mason Research Center
  - Seattle, Washington, United States, 98104
    - Minor and James Medical, PLLC
  - Seattle, Washington, United States, 98112
    - Group Health Central Hospital
  - Seattle, Washington, United States, 98122-4307
    - Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  - Seattle, Washington, United States, 98122
    - Polyclinic First Hill
  - Seattle, Washington, United States, 98195
    - University Cancer Center at University of Washington Medical Center
  - Seattle, Washington, United States, 98104
    - Pacific Medical Center
  - Spokane, Washington, United States, 99202
    - Cancer Care Northwest - Spokane South
  - Spokane, Washington, United States, 99218
    - Evergreen Hematology and Oncology, PS
  - Tacoma, Washington, United States, 98405-3004
    - Franciscan Cancer Center at St. Joseph Medical Center
  - Tacoma, Washington, United States, 98405
    - Allenmore Hospital
  - Tacoma, Washington, United States, 98405
    - CCOP - Northwest
  - Tacoma, Washington, United States, 98405
    - MultiCare Regional Cancer Center at Tacoma General Hospital
  - Tacoma, Washington, United States, 98499
    - St. Clare Hospital
  - Vancouver, Washington, United States, 98668
    - Southwest Washington Medical Center Cancer Center
  - Vancouver, Washington, United States, 98686
    - Legacy Salmon Creek Medical Center
  - Wenatchee, Washington, United States, 98801-2028
    - Wenatchee Valley Medical Center
  - Yakima, Washington, United States, 98902
    - North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Wyoming
  - Casper, Wyoming, United States, 82609
    - Rocky Mountain Oncology
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center at Sheridan Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE

Number of Arms

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12-week FACT-Taxane Neurotoxicity Model-adjusted Score in ALC and Placebo Groups Time Frame: 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	12 weeks post-registration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12-week FACT-Trial Outcome Index(TOI) Functional Status Model-adjusted Score in ALC and Placebo Groups Time Frame: 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	12 weeks post-registration
12-week FACIT-fatigue Model-adjusted Score in ALC and Placebo Groups Time Frame: 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	12 weeks post-registration

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients Experiencing Grade 3 or 4 Neuropathy Time Frame: 12 weeks post-registration	Proportion of patients experiencing grade 3 or 4 neuropathy	12 weeks post-registration
Serum Nerve Growth Factor Levels Time Frame: 12 weeks post-registration		12 weeks post-registration
Treatment and Concurrent Therapy Time Frame: 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	12 weeks post-registration
Association Between Nerve Growth Factor Levels and the Degree of Neuropathy and Functional Status Time Frame: 12 weeks post-registration	Explore the relationship between nerve growth factor levels and the degree of neuropathy and functional status in these patients.	12 weeks post-registration
Association Between Genetic Markers Responsible for Taxane Metabolism and Clearance and the Degree of Neuropathy Time Frame: 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.	12 weeks post-registration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Hershman DL, Unger JM, Crew KD, Minasian LM, Awad D, Moinpour CM, Hansen L, Lew DL, Greenlee H, Fehrenbacher L, Wade JL 3rd, Wong SF, Hortobagyi GN, Meyskens FL, Albain KS. Randomized double-blind placebo-controlled trial of acetyl-L-carnitine for the prevention of taxane-induced neuropathy in women undergoing adjuvant breast cancer therapy. J Clin Oncol. 2013 Jul 10;31(20):2627-33. doi: 10.1200/JCO.2012.44.8738. Epub 2013 Jun 3.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

October 17, 2008

First Submitted That Met QC Criteria

October 17, 2008

First Posted (ESTIMATE)

October 20, 2008

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2017

Last Update Submitted That Met QC Criteria

June 29, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000617081
U10CA037429 (U.S. NIH Grant/Contract)
S0715 (OTHER: SWOG)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (ACTUAL)

Study Completion (ACTUAL)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (ESTIMATE)

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Breast Cancer

Clinical Trials on placebo

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