Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
The Use of Vitamin E for Prevention of Chemotherapy Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study
RATIONALE: Vitamin E may prevent peripheral neuropathy caused by chemotherapy in patients
with cancer. It is not yet known whether vitamin E is more effective than a placebo in
preventing peripheral neuropathy caused by chemotherapy in patients receiving chemotherapy
for cancer.
PURPOSE: This randomized phase III trial is studying vitamin E to see how well it works
compared with placebo in preventing peripheral neuropathy caused by chemotherapy in patients
receiving chemotherapy for cancer.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to type of chemotherapy (taxane vs cisplatin vs carboplatin vs
oxaliplatin vs combination), age (≤ 50 years vs > 50 years), and gender. Patients are
randomized to 1 of 2 treatment arms.
OBJECTIVES:
Primary
- Compare the incidence of chemotherapy-induced sensory peripheral neuropathy ≥ grade 2
in patients undergoing curative neurotoxic chemotherapy for cancer treated with vitamin
E vs placebo.
Secondary
- Compare the proportion of patients requiring dose reductions of chemotherapy secondary
to sensory peripheral neuropathy.
- Compare the proportion of patients stopping chemotherapy before treatment is complete
secondary to sensory peripheral neuropathy.
- Assess the toxicity of vitamin E in these patients.
After completion of study treatment, patients are followed at 6 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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