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