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

Purpose

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 clinical trial is studying D-cycloserine to see how well it works compared to a placebo in treating cancer patients with peripheral neuropathy caused by chemotherapy.

Condition	Intervention	Phase
Neurotoxicity Pain Breast Cancer	Drug: D-cycloserine Other: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care
Official Title:	A Phase III Study of D-Cycloserine in the Management of Paclitaxel-Induced Peripheral Neuropathic Pain in Breast Cancer Patients

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Peripheral Nerve Disorders

Drug Information available for: Cycloserine

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Compare self reported pain intensity score between the control and placebo groups by brief pain inventory [ Time Frame: twice weekly during treatment (12 weeks) ] [ Designated as safety issue: No ]
Compare the self-reported pain intensity in cancer patients receiving chemotherapy or anticancer drugs treated with D-cycloserine vs placebo.
efficacy of regimens for reducing pain [ Time Frame: twice weekly during treatment (12 weeks) ] [ Designated as safety issue: No ]
Compare the efficacy of these regimens, in terms of reducing pain of chronic chemotherapy-induced peripheral neuropathy.

Secondary Outcome Measures:

Self reported pain relief score by brief pain inventory the self-reported pain relief score in patients treated with these drugs. [ Time Frame: twice weekly during treatment (12 weeks) ] [ Designated as safety issue: No ]
the self-reported pain relief score in patients treated with these drugs.
Neuropathic pain scale differences in and between groups by neuropathic pain index [ Time Frame: twice weekly during treatment (12 weeks) ] [ Designated as safety issue: No ]
Compare the change in neuropathic pain scales in patients treated with these drugs.
Compare pain interference between groups by interference scale of the brief pain inventory [ Time Frame: twice weekly during treatment (12 weeks) ] [ Designated as safety issue: No ]
Compare the pain interference in patients treated with these drugs.
Compare the reduction of opioid medication use between groups by opioid equivalents [ Time Frame: twice weekly during treatment (12 weeks) ] [ Designated as safety issue: No ]
Compare the reduction of opioid medication in patients treated with these drugs.

Enrollment:	7
Study Start Date:	February 2006
Study Completion Date:	May 2008
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo will be administered in study-prepared capsules identical to the agent. Patient will take the study drug twice daily in the morning and in the evening every day through the duration of the study. Total duration of treatment is 12 weeks.	Other: Placebo twice daily in the morning and in the evening every day for 12 weeks.
Active Comparator: D-cycloserine D-cycloserine is an oral drug which will be administered in study-prepared capsules. The manufacturer will supply the necessary capsules and identical placebos. Patients in both groups will receive identical capsules. Patients will take the study drug twice daily in the morning and in the evening every day through the duration of the study. Total duration of treatment is 12 weeks.	Drug: D-cycloserine 200 mg dose, twice daily in the morning and in the evening every day for 12 weeks. Other Name: cycloserine; Seromycin™

Arms

Assigned Interventions

Placebo Comparator: Placebo

Placebo will be administered in study-prepared capsules identical to the agent. Patient will take the study drug twice daily in the morning and in the evening every day through the duration of the study. Total duration of treatment is 12 weeks.

Other: Placebo

twice daily in the morning and in the evening every day for 12 weeks.

Active Comparator: D-cycloserine

D-cycloserine is an oral drug which will be administered in study-prepared capsules. The manufacturer will supply the necessary capsules and identical placebos. Patients in both groups will receive identical capsules. Patients will take the study drug twice daily in the morning and in the evening every day through the duration of the study. Total duration of treatment is 12 weeks.

Drug: D-cycloserine

200 mg dose, twice daily in the morning and in the evening every day for 12 weeks.

Other Name: cycloserine; Seromycin™

Detailed Description:

This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral D-cycloserine twice daily.
Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for up to 4 weeks in the absence of unacceptable toxicity. Patients may continue to receive medication off-study at the discretion of their regular oncologist or primary physician.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Selection of Patients - Eligibility 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.
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 may have breast cancer at any stage and no disease specific evaluations will be taken or measured.
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.
Will not concurrently use gabapentin or pregabalin or must be willing to wean offtheir 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. This will be evaluated at the initial visit
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301080

Locations

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Wisconsin
University of Wisconsin School of Medicine
Madison, Wisconsin, United States

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator:	Judith Paice, PhD, RN	Northwestern University
Principal Investigator:	Jamie Von Roenn, MD	Northwestern University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Dr. Jamie Von Roenn, Northwestern University
ClinicalTrials.gov Identifier:	NCT00301080 History of Changes
Other Study ID Numbers:	NU 05CC2, 504-038
Study First Received:	March 8, 2006
Last Updated:	April 8, 2011
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by Northwestern University:

pain
neurotoxicity
breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neuralgia
Neurotoxicity Syndromes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

Poisoning
Substance-Related Disorders
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013