Name of the Trial
Phase III Randomized Study of Alpha-Lipoic Acid in Preventing Platinum-Induced Peripheral Neuropathy in Cancer Patients Receiving a Cisplatin- or Oxaliplatin-Containing Chemotherapy Regimen (MDA-CCC-0327). See the protocol summary at http://cancer.gov/clinicaltrials/MDA-CCC-0327.

Principal Investigator
Dr. Ying Guo, University of Texas M.D. Anderson Cancer Center

Why This Trial Is Important
Peripheral neuropathy is characterized by sensations of pain, tingling, burning, numbness, or weakness that usually begin in the hands or feet. It can be caused by certain illnesses, for example, diabetes. It can also be a side effect of treatment with platinum-based chemotherapy drugs.

Chemotherapy-induced peripheral neuropathy can be either acute or chronic. Acute peripheral neuropathy may begin during or shortly after administration of a platinum-containing drug and usually goes away on its own after several days. Chronic peripheral neuropathy may arise weeks or months after chemotherapy treatment and may be very difficult to treat; in some patients, it may be irreversible.

In this trial, researchers are testing the ability of alpha-lipoic acid to prevent peripheral neuropathy caused by the platinum-containing drugs cisplatin and oxaliplatin. Alpha-lipoic acid is an antioxidant produced naturally by the body; it can also be found in some foods and as a nutritional supplement. In diabetes patients, it has been shown to relieve symptoms of neuropathy.

"Peripheral neuropathy is a potentially disabling condition that affects many cancer patients treated with platinum-based chemotherapy," said Dr. Guo. "We hope that alpha-lipoic acid will help prevent this condition in patients being treated with cisplatin or oxaliplatin."

Patients will be randomly assigned to receive oral alpha-lipoic acid or a placebo three times a day for at least 24 weeks.

Who Can Join This Trial
Researchers will enroll 224 patients scheduled to receive cisplatin- or oxaliplatin-based chemotherapy for cancer and who have not experienced previous peripheral neuropathy. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/MDA-CCC-0327.

Study Sites and Contact Information
Study sites in the United States are recruiting patients for this trial. See the list of study contacts at http://www.cancer.gov/clinicaltrials/MDA-CCC-0327 or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.