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

Phase 3
18 Years
Open (Enrolling)
Breast Cancer, Chemotherapeutic Agent Toxicity, Fatigue, Neuropathy, Neurotoxicity

Thank you

Trial Information

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



- 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.


- 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

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

- 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.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Neurotoxicity as measured by the 11-item neurotoxicity component of the FACT-Taxane Questionnaire at baseline and at 12 weeks

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Laurence H. Baker, DO, FACOI

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2009

Completion Date:

August 2013

Related Keywords:

  • Breast Cancer
  • Chemotherapeutic Agent Toxicity
  • Fatigue
  • Neuropathy
  • Neurotoxicity
  • 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
  • Breast Neoplasms
  • Fatigue
  • Neurotoxicity Syndromes
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations



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