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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 ².

Principal Investigator

Dr. Ying Guo 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.

For More Information

See the lists of entry criteria and trial contact information ² or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.

Glossary Terms

A substance that is being studied for its ability to protect normal cells from the side effects of chemotherapy and prevent peripheral neuropathy (numbness, tingling, burning, and weakness in the hands or feet). Alpha-lipoic acid is made by the body and can be found in foods such as organ meats, spinach, broccoli, peas, brussel sprouts, and rice bran. It can also be made in the laboratory. Alpha-lipoic acid is a type of antioxidant and chemoprotective agent.

A substance that protects cells from the damage caused by free radicals (unstable molecules made by the process of oxidation during normal metabolism). Free radicals may play a part in cancer, heart disease, stroke, and other diseases of aging. Antioxidants include beta-carotene, lycopene, vitamins A, C, and E, and other natural and manufactured substances.

A drug used to treat many types of cancer. Cisplatin contains the metal platinum. It kills cancer cells by damaging their DNA and stopping them from dividing. Cisplatin is a type of alkylating agent. Also called Platinol.

By or having to do with the mouth.

A drug used together with other drugs to treat colorectal cancer that is advanced or has come back. It is also being studied in the treatment of other types of cancer. Oxaliplatin attaches to DNA in cells and may kill cancer cells. It is a type of platinum compound. Also called Eloxatin.

A metal that is an important component of some anticancer drugs, such as cisplatin and carboplatin.

A problem that occurs when treatment affects healthy tissues or organs. Some common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.