Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
M.D. Anderson Cancer Center
With
OBJECTIVES: Primary * 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. Secondary * 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 these drugs. Tertiary * 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.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
