S0715: Acetyl-L-Carnitine in Preventing Neuropathy in Women With Stage I, II, or IIIA Breast Cancer Undergoing Chemo
Condition: Breast Cancer; Chemotherapeutic Agent Toxicity; Fatigue; Neuropathy; Neurotoxicity
MeSH terms: Breast Neoplasms; Peripheral Nervous System Diseases; Neurotoxicity Syndromes; Fatigue
Intervention: acetyl-L-carnitine hydrochloride; placebo
Intervention description: Given orally; Given orally
Intervention MeSH terms: Acetylcarnitine
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 437.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: 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

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.
    

Eligibility 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