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

• Status: Terminated
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Treatments: Cycloserine

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).