Conditions: Neurotoxicity Pain Breast Cancer
Keywords: pain neurotoxicity breast cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 7
Healthy volunteers: no

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

Arms:
arm 1: Placebo administered orally twice per day for 4 weeks. arm 2: D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks. arm 3: D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks. arm 4: This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks. arm 5: Placebo administered orally twice per day for 12 weeks.

Interventions: intervention 1: D-cycloserine intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: