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

Breast Cancer Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neuralgia
• Neurotoxicity
• Neurotoxicity Syndromes
• Pain

• NCT number: NCT00301080
• Study type: Interventional
• Source: Northwestern University
• Status: Terminated
• Phase: Phase 3
• Start date: February 2006
• Completion date: May 2008