Spots Global Cancer Trial Database for D-cycloserine in the Management of Chemotherapy-Induced Peripheral Neuropathic Pain

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Trial Identification

Brief Title: D-cycloserine in the Management of Chemotherapy-Induced Peripheral Neuropathic Pain

Official Title: A Phase III Study of D-Cycloserine in the Management of Paclitaxel-Induced Peripheral Neuropathic Pain in Breast Cancer Patients

Study ID: NCT00301080

Conditions

Neurotoxicity

Pain

Breast Cancer

Interventions

D-cycloserine

Placebo

Study Description

Brief Summary: D-cycloserine may help lessen pain and other symptoms of peripheral neuropathy caused by chemotherapy. It is not yet known whether D-cycloserine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy. This randomized, double-blind, placebo-controlled clinical trial was designed to study D-cycloserine at 2 different doses to see how well each works compared to the other and to a placebo in treating cancer patients with peripheral neuropathy caused by chemotherapy.

Detailed Description: This is a randomized, double-blind, placebo-controlled study. Initially, patients were randomized to 1 of 2 treatment arms (D-cycloserine 250 mg twice daily or placebo twice daily), and treated for up to 4 weeks in the absence of unacceptable toxicity. Later, the design was changed to randomize patients to 1 of 3 arms as follows: * D-cycloserine 50 mg twice daily for up to 12 weeks * D-cycloserine 200 mg twice daily for up to 12 weeks * Placebo twice daily for up to 12 weeks