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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
7
Northwestern University
Chicago, Illinois, United States
University of Wisconsin School of Medicine
Madison, Wisconsin, United States
Difference in Patient-reported Pain Intensity Scores Between the 3 Arms After the Treatment Period Using the Brief Pain Inventory
Compare patient-reported pain intensity scores after the treatment period (12 weeks) between the 3 arms of the trial.
Time frame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
Change in Individual Patients' Self-reported Overall Pain Relief Scores Before and After the Treatment Period
Compare individual patients' self-reported pain relief scores before and after the treatment period.
Time frame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
Change in Neuropathic Pain Scores in and Between Study Arms Using the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.
Compare changes in neuropathic pain scores within each arm, as well as between the 3 arms of the study. Neuropathic pain will be assessed using 3 tools: the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.
Time frame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
Differences in Pain Interference Between Study Arms Using the Brief Pain Inventory and the FACT-Taxane
Compare the pain interference scores after study treatment between study arms using the brief pain inventory and the FACT-Taxane.
Time frame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
Change in the Amount of Opioid Medication Used by Patients in Each Arm Before and After Study Treatment
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Record the amount of opioid medication used by patients in each arm before and after the study treatment period.
Time frame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)