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

Phase 3

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Neurotoxicity

• Registration Number: NCT00363129
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

Study Timeline

• Study First Submitted: 2006-08-10
• Study First Submitted QC: 2006-08-10
• Study First Posted: 2006-08-15
• Study Start: 2006-12
• Primary Completion: 2010-12
• Results First Submitted: 2014-07-17
• Results First Submitted QC: 2014-07-17
• Study Completion: 2014-08
• Results First Posted: 2014-08-08
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-01
• Last Update Posted: 2016-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Chemotherapy-induced Sensory Peripheral Neuropathy ≥ Grade 2	6 months post completion of chemotherapy treatment	The chemotherapy-induced sensory peripheral neuropathy utilized the sensory neuropathy item from the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 0=none; grade 1=loss of deep tendon reflexes or paresthesia, including tingling, but not interfering with function; grade 2=objective sensory alteration or paresthesia, including tingling, interfering with function, but not with activities of daily living; grade 3=sensory alteration or paresthesia interfering with activities of daily living; grade 4=permanent sensory losses that are disabling; and grade 5=death.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Requiring Dose Reductions of Chemotherapy Due to Sensory Peripheral Neuropathy	6 months post completion of chemotherapy treatment
Time to Onset of Sensory Peripheral Neuropathy ≥ Grade 2	6 months post completion of chemotherapy treatment	Time to onset of sensory peripheral neuropathy was calculated using incidences of the adverse event while the patient was receiving chemotherapy.
Percentage of Patients Stopping Chemotherapy Before Treatment is Complete Due to Sensory Peripheral Neuropathy	6 months post completion of chemotherapy treatment
Duration of Sensory Peripheral Neuropathy ≥ Grade 2	6 months post completion of chemotherapy treatment	Duration of sensory peripheral neuropathy is the time from onset of grade 2+ neuropathy until the neuropathy is resolved to grade 1 or less during chemotherapy treatment.

Trial Locations

Locations (69)

St. Joseph Medical Center; 🇺🇸 Bloomington, Illinois, United States

Graham Hospital; 🇺🇸 Canton, Illinois, United States

Memorial Hospital; 🇺🇸 Carthage, Illinois, United States

Eureka Community Hospital; 🇺🇸 Eureka, Illinois, United States

Galesburg Clinic, PC; 🇺🇸 Galesburg, Illinois, United States

Galesburg Cottage Hospital; 🇺🇸 Galesburg, Illinois, United States

Mason District Hospital; 🇺🇸 Havana, Illinois, United States

Hopedale Medical Complex; 🇺🇸 Hopedale, Illinois, United States

Joliet Oncology-Hematology Associates, Limited - West; 🇺🇸 Joliet, Illinois, United States

Kewanee Hospital; 🇺🇸 Kewanee, Illinois, United States

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