NCT00301080

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Neurotoxicity
• Pain
• Breast Cancer

Interventions

Type	Name	Description
DRUG	D-cycloserine
OTHER	Placebo

Timeline

• Start date: 2006-02-01
• Primary completion: 2007-02-01
• Completion: 2008-05-01
• First posted: 2006-03-10
• Last updated: 2013-12-02
• Results posted: 2013-12-02

Locations

2 sites across 1 country: United States