Vitamin E in Preventing Peripheral Neuropathy Caused by Chemotherapy in Patients Receiving Chemotherapy for Cancer
Condition: Neurotoxicity; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Peripheral Nervous System Diseases; Neurotoxicity Syndromes
Intervention: vitamin E; placebo
Intervention description: Given orally; Given orally
Intervention MeSH terms: Vitamin E
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 207.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neurotoxicity; unspecified adult solid tumor, protocol specific

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.
    

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