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

Phase 3

Terminated

• Conditions: Neurotoxicity; Pain; Breast Cancer
• Interventions: Other: Placebo; Drug: D-cycloserine

• Registration Number: NCT00301080
• Lead Sponsor: Northwestern University

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

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-03-08
• Study First Submitted QC: 2006-03-08
• Study First Posted: 2006-03-10
• Primary Completion: 2007-02
• Study Completion: 2008-05
• Status Verified: 2013-11
• Results First Submitted: 2013-11-25
• Results First Submitted QC: 2013-11-25
• Last Update Submitted: 2013-11-25
• Results First Posted: 2013-12-02
• Last Update Posted: 2013-12-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Patients will be at least 18 years of age.
• Patients will be experiencing moderate to severe peripheral neuropathic pain
• Patients may be on chronic adjuvant pain medications such as antidepressants but must be on stable doses for at least one week prior to admission.
• Patients may be taking concurrent opioids but they must be willing to allow us to monitor their opioid use while on the trial.
• Patients must have chronic peripheral neuropathic pain will be defined as pain of 3 or more months duration which began in association with chemotherapy.
• Patient's will have bilateral peripheral neuropathic pain symptoms primarily involving the feet
• Patients must have breast cancer (any stage)
• Patients must be able to read and speak English and provide informed consent.
• Patients may be receiving chemotherapy as long as the agents are not known to cause a peripheral neuropathy.
• Patients must have an ECOG Performance Status < 3 and be able to attend the physician study visits
• Patients must not concurrently use gabapentin or pregabalin or must be willing to wean off their anti-convulsant medications prior to starting the trial.
• Patients may have diabetes mellitus (type 1 or 2) as long as there is no preexisting neuropathy.

Exclusion criteria:

• Patients will not have secondary cause of neuropathic pain including: HIV/AIDS,traumatic injury, or a personal history of non chemotherapy-induced neuropathy.
• Patients will not have a history of major depression or severe anxiety.
• Women of childbearing age will agree to take measures to prevent pregnancy and will not breast-feed while on the study medication. Women who are currently pregnant will not be invited to participate in this study.
• Patients will not have a history of seizures.
• Patients cannot be currently receiving antibiotic therapy for tuberculosis (e.g. isoniazid).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (original version)	Placebo	Placebo administered orally twice per day for 4 weeks.
Placebo (revised version)	Placebo	Placebo administered orally twice per day for 12 weeks.
D-cycloserine 50 mg	D-cycloserine	D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
D-cycloserine 250mg	D-cycloserine	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.
D-cycloserine 200mg	D-cycloserine	D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Difference in Patient-reported Pain Intensity Scores Between the 3 Arms After the Treatment Period Using the Brief Pain Inventory	From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)	Compare patient-reported pain intensity scores after the treatment period (12 weeks) between the 3 arms of the trial.

Secondary Outcome Measures

Name	Time	Method
Differences in Pain Interference Between Study Arms Using the Brief Pain Inventory and the FACT-Taxane	From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)	Compare the pain interference scores after study treatment between study arms using the brief pain inventory and the FACT-Taxane.
Change in the Amount of Opioid Medication Used by Patients in Each Arm Before and After Study Treatment	From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)	Record the amount of opioid medication used by patients in each arm before and after the study treatment period.
Change in Individual Patients' Self-reported Overall Pain Relief Scores Before and After the Treatment Period	From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)	Compare individual patients' self-reported pain relief scores before and after the treatment period.
Change in Neuropathic Pain Scores in and Between Study Arms Using the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.	From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)	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.

Trial Locations

Locations (2)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of Wisconsin School of Medicine; 🇺🇸 Madison, Wisconsin, United States