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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00301080
Recruitment Status : Terminated (Funding for the study fell through.)
First Posted : March 10, 2006
Results First Posted : December 2, 2013
Last Update Posted : December 2, 2013
Sponsor:
Information provided by (Responsible Party):
Northwestern University

Tracking Information
First Submitted Date  ICMJE March 8, 2006
First Posted Date  ICMJE March 10, 2006
Results First Submitted Date  ICMJE November 25, 2013
Results First Posted Date  ICMJE December 2, 2013
Last Update Posted Date December 2, 2013
Study Start Date  ICMJE February 2006
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
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) ]
Compare patient-reported pain intensity scores after the treatment period (12 weeks) between the 3 arms of the trial.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00301080 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
  • 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) ]
    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) ]
    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) ]
    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) ]
    Record the amount of opioid medication used by patients in each arm before and after the study treatment period.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE D-cycloserine in the Management of Chemotherapy-Induced Peripheral Neuropathic Pain
Official Title  ICMJE A Phase III Study of D-Cycloserine in the Management of Paclitaxel-Induced Peripheral Neuropathic Pain in Breast Cancer Patients
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Neurotoxicity
  • Pain
  • Breast Cancer
Intervention  ICMJE
  • Drug: D-cycloserine
    Other Name: Cycloserine; Seromycin™
  • Other: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo (original version)
    Placebo administered orally twice per day for 4 weeks.
    Intervention: Other: Placebo
  • Active Comparator: D-cycloserine 200mg
    D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
    Intervention: Drug: D-cycloserine
  • Active Comparator: D-cycloserine 50 mg
    D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
    Intervention: Drug: D-cycloserine
  • 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.
    Intervention: Drug: D-cycloserine
  • Placebo Comparator: Placebo (revised version)
    Placebo administered orally twice per day for 12 weeks.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 24, 2010)
7
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00301080
Other Study ID Numbers  ICMJE NU 05CC2
504-038 ( Other Identifier: Northwestern University IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Judith Paice, PhD, RN Northwestern University
Principal Investigator: Jamie Von Roenn, MD Northwestern University
PRS Account Northwestern University
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP