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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00775645
First received: October 17, 2008
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Breast Cancer
Chemotherapeutic Agent Toxicity
Fatigue
Neuropathy
Neurotoxicity
Dietary Supplement: acetyl-L-carnitine hydrochloride
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Neurotoxicity as measured by the 11-item neurotoxicity component of the FACT-Taxane Questionnaire at baseline and at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Functional status as measured by the FACT-Taxane Trial Outcome Index at baseline and at 12, 24, and 36 weeks [ Time Frame: 12, 24 and 36 weeks ] [ Designated as safety issue: No ]
  • Fatigue as measured by the FACIT-Fatigue Symptom Module at baseline and at 12, 24, and 36 weeks [ Time Frame: 12, 24, and 36 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients experiencing grade 2 or 3 neuropathy as measured by NCI CTCAE v3.0 criteria at 12, 24, and 36 weeks [ Time Frame: 12, 24, and 36 weeks ] [ Designated as safety issue: Yes ]
  • Nerve growth factor levels at baseline and 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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, 24 and 36 weeks ] [ Designated as safety issue: No ]
  • Relationship between nerve growth factor levels and the degree of neuropathy and functional status [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • Relationship between genetic markers responsible for taxane metabolism and clearance and degree of neuropathy [ Time Frame: end of study ] [ Designated as safety issue: No ]

Enrollment: 437
Study Start Date: September 2009
Study Completion Date: June 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 FACT-Taxane Questionnaire.
  • Compare fatigue in these patients using the FACIT-Fatigue Symptom Module.
  • Compare the proportion of patients experiencing grade 2 or 3 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00775645

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

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00775645     History of Changes
Other Study ID Numbers: CDR0000617081, S0715, U10CA037429
Study First Received: October 17, 2008
Last Updated: January 13, 2014
Health Authority: United States: Food and Drug Administration

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
Fatigue
Neurotoxicity Syndromes
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms
Nervous System Diseases
Poisoning
Substance-Related Disorders
Peripheral Nervous System Diseases
Neuromuscular Diseases
Acetylcarnitine
Carnitine
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014