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

Breast Cancer Clinical Trial

Official title:

A Phase III Study of D-Cycloserine in the Management of Paclitaxel-Induced Peripheral Neuropathic Pain in Breast Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00301080
• Other study ID #: NU 05CC2
• Secondary ID: 504-038
• Status: Terminated
• Phase: Phase 3
• First received: March 8, 2006
• Last updated: November 25, 2013
• Start date: February 2006
• Est. completion date: May 2008

Study information

• Verified date: November 2013
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: May 2008
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neuralgia
• Neurotoxicity
• Neurotoxicity Syndromes
• Pain

Intervention

Drug:
• D-cycloserine

Other:
• Placebo

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	University of Wisconsin School of Medicine	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Patient-reported Pain Intensity Scores Between the 3 Arms After the Treatment Period Using the Brief Pain Inventory	Compare patient-reported pain intensity scores after the treatment period (12 weeks) between the 3 arms of the trial.	From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)	No
Secondary	Change in Individual Patients' Self-reported Overall Pain Relief Scores Before and After the Treatment Period	Compare individual patients' self-reported pain relief scores before and after the treatment period.	From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)	No
Secondary	Change in Neuropathic Pain Scores in and Between Study Arms Using the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.	Compare changes in neuropathic pain scores within each arm, as well as between the 3 arms of the study. Neuropathic pain will be assessed using 3 tools: the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.	From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)	No
Secondary	Differences in Pain Interference Between Study Arms Using the Brief Pain Inventory and the FACT-Taxane	Compare the pain interference scores after study treatment between study arms using the brief pain inventory and the FACT-Taxane.	From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)	No
Secondary	Change in the Amount of Opioid Medication Used by Patients in Each Arm Before and After Study Treatment	Record the amount of opioid medication used by patients in each arm before and after the study treatment period.	From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)	No