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

NCT ID: NCT00301080

Last Updated: 2013-12-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-05-31

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

Conditions

Neurotoxicity; Pain; Breast Cancer

Keywords

pain; neurotoxicity; breast cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Placebo (original version)

Placebo administered orally twice per day for 4 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

D-cycloserine 200mg

D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.

Group Type: ACTIVE_COMPARATOR

D-cycloserine

Intervention Type: DRUG

D-cycloserine 50 mg

D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.

Group Type: ACTIVE_COMPARATOR

D-cycloserine

Intervention Type: DRUG

D-cycloserine 250mg

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.

Group Type: ACTIVE_COMPARATOR

D-cycloserine

Intervention Type: DRUG

Placebo (revised version)

Placebo administered orally twice per day for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

D-cycloserine

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Other Intervention Names

Cycloserine; Seromycin™

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judith Paice, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Jamie Von Roenn, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

University of Wisconsin School of Medicine

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

504-038

Identifier Type: OTHER

Identifier Source: secondary_id

NU 05CC2

Identifier Type: -

Identifier Source: org_study_id