Vitamin E in Preventing Peripheral Neuropathy Caused by Chemotherapy in Patients Receiving Chemotherapy for Cancer
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|ClinicalTrials.gov Identifier: NCT00363129|
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : August 8, 2014
Last Update Posted : July 6, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Neurotoxicity Unspecified Adult Solid Tumor, Protocol Specific||Dietary Supplement: vitamin E Other: placebo||Phase 3|
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.
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||207 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Use of Vitamin E for Prevention of Chemotherapy Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||August 2014|
Experimental: Arm I
Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
Dietary Supplement: vitamin E
Placebo Comparator: Arm II
Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
- Percentage of Patients With Chemotherapy-induced Sensory Peripheral Neuropathy ≥ Grade 2 [ Time Frame: 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.
- Percentage of Patients Requiring Dose Reductions of Chemotherapy Due to Sensory Peripheral Neuropathy [ Time Frame: 6 months post completion of chemotherapy treatment ]
- Percentage of Patients Stopping Chemotherapy Before Treatment is Complete Due to Sensory Peripheral Neuropathy [ Time Frame: 6 months post completion of chemotherapy treatment ]
- Time to Onset of Sensory Peripheral Neuropathy ≥ Grade 2 [ Time Frame: 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.
- Duration of Sensory Peripheral Neuropathy ≥ Grade 2 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363129
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|Study Chair:||Lisa Kottschade, RN, MSN, CNP||Mayo Clinic|