A Phase III Study of D-Cycloserine in the Management of Paclitaxel-Induced Peripheral Neuropathic Pain in Breast Cancer Patients
This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive oral D-cycloserine twice daily.
- Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues
for up to 4 weeks in the absence of unacceptable toxicity. Patients may continue to
receive medication off-study at the discretion of their regular oncologist or primary
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Compare self reported pain intensity score between the control and placebo groups by brief pain inventory
Compare the self-reported pain intensity in cancer patients receiving chemotherapy or anticancer drugs treated with D-cycloserine vs placebo.
twice weekly during treatment (12 weeks)
Judith Paice, PhD, RN
United States: Food and Drug Administration
|Northwestern University||Chicago, Illinois 60611|
|University of Wisconsin School of Medicine||Madison, Wisconsin|