Status:
TERMINATED
D-cycloserine in the Management of Chemotherapy-Induced Peripheral Neuropathic Pain
Lead Sponsor:
Northwestern University
Conditions:
Neurotoxicity
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00301080
Start Date
February 1 2006
End Date
May 1 2008
Last Update
December 2 2013
Active Locations (2)
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1
Northwestern University
Chicago, Illinois, United States, 60611-3013
2
University of Wisconsin School of Medicine
Madison, Wisconsin, United States