Vitamin E in Preventing Peripheral Neuropathy Caused by Chemotherapy in Patients Receiving Chemotherapy for Cancer
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Purpose
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 a placebo in preventing peripheral neuropathy caused by chemotherapy in patients receiving chemotherapy for cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Neurotoxicity Unspecified Adult Solid Tumor, Protocol Specific |
Dietary Supplement: vitamin E Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind 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 |
- Percentage of patients with chemotherapy-induced sensory peripheral neuropathy ≥ grade 2 as measured by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Proportion of patients requiring dose reductions of chemotherapy due to sensory peripheral neuropathy [ Designated as safety issue: Yes ]
- Proportion of patients stopping chemotherapy before treatment is complete due to sensory peripheral neuropathy [ Designated as safety issue: Yes ]
- Toxicity of vitamin E [ Designated as safety issue: Yes ]
- Time to onset of sensory peripheral neuropathy ≥ grade 2 [ Designated as safety issue: Yes ]
- Average duration of sensory peripheral neuropathy ≥ grade 2 [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | December 2006 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Given orally
|
|
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.
|
Other: placebo
Given orally
|
Detailed Description:
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.
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.
- 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.
- 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.
After completion of study treatment, patients are followed at 6 months.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Scheduled to undergo curative-intent adjuvant neurotoxic chemotherapy for cancer
Regimen must include ≥ 1 of the following neurotoxic chemotherapeutic agents:
- Taxanes (e.g., paclitaxel or docetaxel)
- Platinum compounds (e.g., cisplatin, carboplatin, or oxaliplatin*) NOTE: *Patients receiving oxaliplatin should preferentially be enrolled in protocol NCCTG-N04C7
- No preexisting or history of peripheral neuropathy due to any cause (e.g., diabetes, alcohol, toxin, or hereditary)
- Must have resected tumor with or without microscopic residual disease or residual margin involvement
- No head and neck cancers
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 6 months
- Able to complete questionnaire(s) alone or with assistance
- Not pregnant or nursing
- Fertile patients must use effective contraception
No history of coronary artery disease, including, any of the following:
- Myocardial infarction within the past 5 years
- Percutaneous transluminal coronary angioplasty within the past 5 years
- Coronary artery bypass graft within the past 5 years
- New York Heart Association class I-IV congestive heart failure
- No other medical conditions that would contraindicate study therapy
- No history of hemorrhagic stroke
- No diabetes requiring insulin or oral hypoglycemic medications
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior valve replacement surgery allowed provided patient has fully recovered from the surgery
No prior neurotoxic chemotherapy unless the following criteria are met:
- Patient has started neurotoxic chemotherapy within 4 days of starting vitamin E on this study
- Patient has not been previously treated with other neurotoxic chemotherapy agents
- No vitamin E supplementation within 7 days prior to randomization (except for 1 multivitamin per day that contains ≤ 100 mg of vitamin E)
- No concurrent neoadjuvant therapy
- No concurrent chemotherapy for palliative care
No concurrent regular opioid-containing medications
- Opioids for short-term treatment of chemotherapy-induced myalgias or arthralgias caused by taxanes allowed
- No concurrent anticonvulsants, tricyclic antidepressants, or other neuropathic pain medications (e.g., carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch, or capsaicin cream)
No concurrent anticoagulant medication (e.g., warfarin, low molecular weight heparin, or platelet-aggregation inhibitors, such as clopidgrel or acetylsalicylic acid)
- 1 mg/day of warfarin for central line maintenance is allowed
- No planned concurrent radiotherapy
- No other concurrent therapy for chemotherapy-induced peripheral neuropathy
Contacts and Locations
Show 69 Study Locations| Investigator: | Lisa Kottschade, RN, MSN, CNP | Mayo Clinic |
| Investigator: | Miroslaw A. Mazurczak, MD, MP | Sanford Cancer Center at Sanford USD Medical Center |
| Investigator: | Charles L. Loprinzi, MD | Mayo Clinic |
| Investigator: | DeAnne Smith, RN, CNP | Mayo Clinic |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00363129 History of Changes |
| Other Study ID Numbers: | CDR0000491071, NCCTG-N05C3 |
| Study First Received: | August 10, 2006 |
| Last Updated: | May 10, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
neurotoxicity unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Peripheral Nervous System Diseases Neurotoxicity Syndromes Neuromuscular Diseases Nervous System Diseases Poisoning Substance-Related Disorders Vitamin E Alpha-Tocopherol Tocopherols |
Tocotrienols Vitamins Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 23, 2013