The Use of Vitamin E for Prevention of Chemotherapy Induced Peripheral Neuropathy: A Phase III Double-Blind Placebo Controlled Study

Inclusion Criteria

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