NCT00363129

Vitamin E in Preventing Peripheral Neuropathy Caused by Chemotherapy in Patients Receiving Chemotherapy for Cancer

The Use of Vitamin E for Prevention of Chemotherapy Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Neurotoxicity
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	vitamin E	Given orally
OTHER	placebo	Given orally

Timeline

• Start date: 2006-12-01
• Primary completion: 2010-12-01
• Completion: 2014-08-01
• First posted: 2006-08-15
• Last updated: 2016-07-06
• Results posted: 2014-08-08

Locations

69 sites across 1 country: United States