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

Launched by ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY · Aug 10, 2006

Keywords

ClinConnect Summary

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 c...

Gender

ALL

Eligibility criteria

• Required Characteristics:
• • 1. 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).
• • 2. ≥ 18 years of age
• • 3. Ability to sign informed consent and understand the nature of a placebo-controlled trial
• • 4. ECOG Performance Status (PS) of 0, 1, or 2 e.g.
• • 5. Ability to complete questionnaire(s) by themselves or with assistance
• • 6. Life expectancy ≥ 6 months
• Contraindications:
• • 1. Undergoing chemotherapy for palliative care
• • 2. Pre-existing history of peripheral neuropathy due to any cause (diabetes, alcohol, toxin, hereditary, etc).
• • 3. 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).
• • 4. Taking regular opioid-containing medications. (Exception: opioids, given for the short term treatment of chemotherapy-induced myalgias or arthralgias caused by taxanes are permitted.)
• • 5. 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.
• • 6. 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.
• • 7. Other medical conditions, which in the opinion of the treating physician/allied health professional would make this protocol unreasonably hazardous for the patient.
• 8. 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.)
• • 9. Any of the following: pregnant women, nursing women and men or women of childbearing potential who are unwilling to employ adequate contraception
• • 10. 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.
• • 11. Diagnosed diabetes requiring insulin or oral hypoglycemic medications
• • 12. Head or neck cancers
• • 13. Scheduled to undergo radiation therapy while on study
• • 14. History of hemorrhagic stroke
• • 15. Patients receiving neo-adjuvant therapy