Clinical trial NCT00301080: D-cycloserine in the Management of Chemotherapy-Induced Peripheral Neuropathic Pain
Official title: A Phase III Study of D-Cycloserine in the Management of Paclitaxel-Induced Peripheral Neuropathic Pain in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Neurotoxicity
Pain
Breast Cancer
Keywords: pain
neurotoxicity
breast cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2006-03-10
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

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 to 4 weeks in the absence of unacceptable toxicity.

Later, the design was changed to randomize patients to 1 of 3 arms as follows:

* D-cycloserine 50 mg twice daily for up to 12 weeks
* D-cycloserine 200 mg twice daily for up to 12 weeks
* Placebo twice daily for up to 12 weeks

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).

Primary outcomes:
measure: Difference in Patient-reported Pain Intensity Scores Between the 3 Arms After the Treatment Period Using the Brief Pain Inventory
timeFrame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
Secondary outcomes:
measure: Change in Individual Patients' Self-reported Overall Pain Relief Scores Before and After the Treatment Period
timeFrame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
measure: Change in Neuropathic Pain Scores in and Between Study Arms Using the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.
timeFrame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
measure: Differences in Pain Interference Between Study Arms Using the Brief Pain Inventory and the FACT-Taxane
timeFrame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
measure: Change in the Amount of Opioid Medication Used by Patients in Each Arm Before and After Study Treatment
timeFrame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Madison
country: United States
facility: University of Wisconsin School of Medicine
state: Wisconsin
Study officials:
affiliation: Northwestern University
name: Judith Paice, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Jamie Von Roenn, MD
role: PRINCIPAL_INVESTIGATOR
References: