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

This study has been terminated.
(Funding for the study fell through.)
Sponsor:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00301080
First received: March 8, 2006
Last updated: November 25, 2013
Last verified: November 2013
  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, 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.


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:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Difference in Patient-reported Pain Intensity Scores Between the 3 Arms After the Treatment Period Using the Brief Pain Inventory [ Time Frame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year) ] [ Designated as safety issue: No ]
    Compare patient-reported pain intensity scores after the treatment period (12 weeks) between the 3 arms of the trial.


Secondary Outcome Measures:
  • Change in Individual Patients' Self-reported Overall Pain Relief Scores Before and After the Treatment Period [ Time Frame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year) ] [ Designated as safety issue: No ]
    Compare individual patients' self-reported pain relief scores before and after the treatment period.

  • Change in Neuropathic Pain Scores in and Between Study Arms Using the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale. [ Time Frame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year) ] [ Designated as safety issue: No ]
    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.

  • Differences in Pain Interference Between Study Arms Using the Brief Pain Inventory and the FACT-Taxane [ Time Frame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year) ] [ Designated as safety issue: No ]
    Compare the pain interference scores after study treatment between study arms using the brief pain inventory and the FACT-Taxane.

  • Change in the Amount of Opioid Medication Used by Patients in Each Arm Before and After Study Treatment [ Time Frame: From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year) ] [ Designated as safety issue: No ]
    Record the amount of opioid medication used by patients in each arm before and after the study treatment period.


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 (original version)
Placebo administered orally twice per day for 4 weeks.
Other: Placebo
Active Comparator: D-cycloserine 200mg
D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
Drug: D-cycloserine
Other Name: Cycloserine; Seromycin™
Active Comparator: D-cycloserine 50 mg
D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
Drug: D-cycloserine
Other Name: Cycloserine; Seromycin™
Active Comparator: D-cycloserine 250mg
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.
Drug: D-cycloserine
Other Name: Cycloserine; Seromycin™
Placebo Comparator: Placebo (revised version)
Placebo administered orally twice per day for 12 weeks.
Other: Placebo

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

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

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00301080     History of Changes
Other Study ID Numbers: NU 05CC2, 504-038
Study First Received: March 8, 2006
Results First Received: November 25, 2013
Last Updated: November 25, 2013
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 April 20, 2014