D-cycloserine in the Management of Chemotherapy-Induced Peripheral Neuropathic Pain
Neurotoxicity, Pain, Breast Cancer
About this trial
This is an interventional supportive care trial for Neurotoxicity focused on measuring pain, neurotoxicity, breast cancer
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).
Sites / Locations
- Northwestern University
- University of Wisconsin School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Placebo (original version)
D-cycloserine 200mg
D-cycloserine 50 mg
D-cycloserine 250mg
Placebo (revised version)
Placebo administered orally twice per day for 4 weeks.
D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
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.
Placebo administered orally twice per day for 12 weeks.