Status:
COMPLETED
Vitamin E in Preventing Peripheral Neuropathy Caused by Chemotherapy in Patients Receiving Chemotherapy for Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Neurotoxicity
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 n...
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 comb...
Eligibility Criteria
Inclusion
- Required Characteristics:
- Scheduled to undergo curative-intent adjuvant treatment with neurotoxic chemotherapy. Patients must have had his/her tumor removed, but may have microscopic residual disease, or residual margin involvement and still be eligible.
- The patient's chemotherapy regimen must include one or more of the following neurotoxic chemotherapeutic agents: taxanes (paclitaxel, docetaxel); platinum compounds (cisplatin, carboplatin, oxaliplatin)-(oxaliplatin patients should preferentially be enrolled in protocol N04C7 while it is available).
- ≥ 18 years of age
- Ability to sign informed consent and understand the nature of a placebo-controlled trial
- ECOG Performance Status (PS) of 0, 1, or 2 e.g.
- Ability to complete questionnaire(s) by themselves or with assistance
- Life expectancy ≥ 6 months
- Contraindications:
- Undergoing chemotherapy for palliative care
- Pre-existing history of peripheral neuropathy due to any cause (diabetes, alcohol, toxin, hereditary, etc).
- Prior treatment with neurotoxic chemotherapy (exception: Patient started neurotoxic chemotherapy ≤ 4 days of starting vitamin E on this study and has not been treated previously with other neurotoxic chemotherapy agents).
- Taking regular opioid-containing medications. (Exception: opioids, given for the short term treatment of chemotherapy-induced myalgias or arthralgias caused by taxanes are permitted.)
- Concurrent treatment with anticonvulsants, tricyclic antidepressants, or other neuropathic pain medications agents such as carbamazepine, phenytoin, valproic acid, gabapentin, lamotrigine, topical lidocaine patch, capsaicin cream, etc.
- History of coronary artery disease (i.e. MI, PTCA, or CABG ≤ 5 years or diagnosis of congestive heart failure of any NY heart class I-IV) Valve replacements are permitted as long as patient has fully recovered from the surgery.
- Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient.
- Vitamin E supplementation for any reason ≤ 7 days prior to randomization. (Exception:
- one multivitamin per day that contains ≤ 100 IU \[mg\] of Vitamin E, will be permitted.)
- Any of the following: pregnant women, nursing women and men or women of childbearing potential who are unwilling to employ adequate contraception
- Taking anticoagulant medication (i.e. coumadin, low molecular weight heparin (LMWH), or platelet aggregation inhibitors such as clopidgrel or aspirin) with the exception that 1 mg/day of coumadin for central line maintenance is allowed.
- Diagnosed diabetes requiring insulin or oral hypoglycemic medications
- Head or neck cancers
- Scheduled to undergo radiation therapy while on study
- History of hemorrhagic stroke
- Patients receiving neo-adjuvant therapy
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT00363129
Start Date
December 1 2006
End Date
August 1 2014
Last Update
July 6 2016
Active Locations (69)
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1
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
2
Graham Hospital
Canton, Illinois, United States, 61520
3
Memorial Hospital
Carthage, Illinois, United States, 62321
4
Eureka Community Hospital
Eureka, Illinois, United States, 61530