Prevention of Cisplatin- or Oxaliplatin-Induced Peripheral Neuropathy With Alpha-Lipoic Acid: A Placebo-Controlled Phase III Trial

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Scheduled to receive a cisplatin- or oxaliplatin-containing chemotherapy regimen for
cancer

- No established clinical neuropathy

- No clinically evident CNS metastases, including leptomeningeal metastases

PATIENT CHARACTERISTICS:

AGE

- Not specified PERFORMANCE STATUS

- Not specified LIFE EXPECTANCY

- Not specified HEMATOPOIETIC

- Not specified HEPATIC

- Bilirubin < 2 mg/dL RENAL

- Creatinine < 2 mg/dL OR

- Creatinine clearance > 45 mL/min OTHER

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Must have a normal state of arousal

- No confusion or memory or concentration deficit

- No history of diabetes mellitus requiring oral medication or insulin treatment

- No chronic alcoholism

- No other active CNS disease (e.g., dementia or encephalopathy)

PRIOR CONCURRENT THERAPY:

BIOLOGIC THERAPY

- Not specified CHEMOTHERAPY

- See Disease Characteristics

- No carboplatin, vincristine, vinblastine, paclitaxel, or docetaxel for 6 months
prior, during, and 6 months after study treatment ENDOCRINE THERAPY

- Not specified RADIOTHERAPY

- Not specified SURGERY

- Not specified OTHER

- Concurrent medications that can modify peripheral neuropathy (e.g., gabapentin,
lamotrigine, carbamazepine, phenytoin, or tricyclic antidepressants) are allowed
provided there is no dose adjustment within 2 weeks before study entry and during
study participation

- No concurrent vitamin E (including multivitamins that contain vitamin E) ≥ 100 IU per
day

- No concurrent physical modality (e.g., annodyne [monochromatic near-infrared
photoenergy, 890 nm], microcurrent, or transcutaneous electrical neural stimulation)
for peripheral neuropathy related symptoms unless physical or occupational therapy
for functional training