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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Breast Diseases
Chemically-Induced Disorders
Neoplasms
Neoplasms by Site
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Poisoning
Signs and Symptoms
Skin Diseases
Cycloserine
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antibiotics, Antitubercular
Antimetabolites
Antitubercular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014