500 Boylston Street, Boston, MA 02116 617-419-4700
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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.
Ages:18 and older
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
Sponsor: Southwest Oncology Group
Phase: Phase 3
Trial ID: NCT00775645
Not Accepting Healthy Volunteers