Prevention of Cisplatin- or Oxaliplatin-Induced Peripheral Neuropathy With Alpha-Lipoic Acid: A Placebo-Controlled Phase III Trial
- Compare whether treatment with alpha-lipoic acid vs placebo decreases the severity and
frequency of peripheral neuropathy in cancer patients receiving a cisplatin- or
oxaliplatin-containing chemotherapy regimen.
- Compare the protective effect duration of these drugs in these patients.
- Determine large sensory fiber integrity associated with platinum-induced peripheral
neuropathy, as measured by three timed functional tests comprising fastening 6-buttons,
walking 50 feet, and placing coins in a cup, in patients treated with these drugs.
- Compare the number of chemotherapy courses and doses received by patients treated with
- Compare the optimal tumor response (disease progression, stable disease, partial
response, or complete response) to chemotherapy in patients treated with these drugs.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to prior platinum-containing treatment (yes vs no). Patients who
received prior treatment are further stratified according to prior cumulative platinum
exposure (cisplatin < 200 mg/m^2 or oxaliplatin < 750 mg/m^2 vs cisplatin 200-399 mg/m^2 or
oxaliplatin 750-999 mg/m^2 vs cisplatin >400 mg/m^2 or oxaliplatin > 1,000 mg/m^2). Patients
are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral alpha-lipoic acid* three times daily for at least 24 weeks
in the absence of unacceptable toxicity.
- Arm II: Patients receive oral placebo* three times daily for at least 24 weeks in the
absence of unacceptable toxicity.
NOTE: *In both arms, patients begin taking study drug 4 days after completion of each
chemotherapy treatment and continue taking study drug until 2 days before their next
scheduled chemotherapy treatment.
Patients' symptoms of peripheral neuropathy, pain, and functional tests are assessed at
baseline and then at weeks 6-8, 12, 24, 36, and 48.
PROJECTED ACCRUAL: A total of 244 patients (122 per treatment arm) will be accrued for this
study within 2 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Severity of neuropathy
Severity of neuropathy as measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity Questionnaire total score at baseline and at 6-8, 12, 24, 36, and 48 weeks
Up to 48 weeks
Ying Guo, MD, MS
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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