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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Neurotoxicity, Pain, Breast Cancer

In brief

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.

Key facts

Study ID

NCT00301080

Run by

Northwestern University

People needed

7

Starts

2006-02-01

Expected to finish

2008-05-01

Last updated by the study team

2013-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Northwestern University — Chicago, Illinois, United States
• University of Wisconsin School of Medicine — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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