Clinical trial · Interventional
D-cycloserine in the Management of Chemotherapy-Induced Peripheral Neuropathic Pain
A Phase III Study of D-Cycloserine in the Management of Paclitaxel-Induced Peripheral Neuropathic Pain in Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding for the study fell through.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Neurotoxicity | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| D-cycloserine | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- PLACEBO_COMPARATOR
- label
- Placebo (original version)
- description
- Placebo administered orally twice per day for 4 weeks.
- interventionNames
- Other: Placebo
- type
- ACTIVE_COMPARATOR
- label
- D-cycloserine 200mg
- description
- D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
- interventionNames
- Drug: D-cycloserine
- type
- ACTIVE_COMPARATOR
- label
- D-cycloserine 50 mg
- description
- D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available