Alpha-Lipoic Acid in Preventing Peripheral Neuropathy in Patients Receiving Chemotherapy for Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Neurology |
| Therapuetic Areas: | Neurology, Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | January 2007 |
| Contact: | Robert Wieder, MD, PhD |
| Email: | wiederro@umdnj.edu |
| Phone: | 9739724871 |
Prevention of Cisplatin- or Oxaliplatin-Induced Peripheral Neuropathy With Alpha-Lipoic Acid: A Placebo-Controlled Phase III Trial
The purpose of this study is to find out the effects (good and bad) Alpha-Lipoic Acid (ALA)
has on preventing a side effect of platinum-containing chemotherapy called peripheral
neuropathy. In this study, one group of subjects will receive Alpha-Lipoic Acid (ALA) and
another group will receive a placebo control pill. A placebo control pill is a
"look-a-like" pill but does not have any medication in it. Another name for placebo pill is
"sugar pill." Peripheral neuropathy is an abnormal, uncomfortable, often painful, sensations
and feelings in hands or feet. The sensations and feelings in the hands and feet can effect
the normal use of the hands and feet, such as in buttoning, writing, typing, sewing, picking
up small objects, and walking.
Currently there is no standard or reliable therapy to prevent this type of neuropathy.
Alpha-Lipoic Acid (ALA) is a dietary supplement that is supposed to prevent or reduce the
symptoms.
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
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