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

Primary Purpose

Neurotoxicity, Pain, Breast Cancer

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
D-cycloserine
Placebo
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neurotoxicity focused on measuring pain, neurotoxicity, breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Northwestern University
  • University of Wisconsin School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Placebo (original version)

D-cycloserine 200mg

D-cycloserine 50 mg

D-cycloserine 250mg

Placebo (revised version)

Arm Description

Placebo administered orally twice per day for 4 weeks.

D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.

D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.

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.

Placebo administered orally twice per day for 12 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 8, 2006
Last Updated
November 25, 2013
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT00301080
Brief Title
D-cycloserine in the Management of Chemotherapy-Induced Peripheral Neuropathic Pain
Official Title
A Phase III Study of D-Cycloserine in the Management of Paclitaxel-Induced Peripheral Neuropathic Pain in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
Funding for the study fell through.
Study Start Date
February 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurotoxicity, Pain, Breast Cancer
Keywords
pain, neurotoxicity, breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo (original version)
Arm Type
Placebo Comparator
Arm Description
Placebo administered orally twice per day for 4 weeks.
Arm Title
D-cycloserine 200mg
Arm Type
Active Comparator
Arm Description
D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
Arm Title
D-cycloserine 50 mg
Arm Type
Active Comparator
Arm Description
D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
Arm Title
D-cycloserine 250mg
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo (revised version)
Arm Type
Placebo Comparator
Arm Description
Placebo administered orally twice per day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
D-cycloserine
Other Intervention Name(s)
Cycloserine; Seromycin™
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Difference in Patient-reported Pain Intensity Scores Between the 3 Arms After the Treatment Period Using the Brief Pain Inventory
Description
Compare patient-reported pain intensity scores after the treatment period (12 weeks) between the 3 arms of the trial.
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)
Secondary Outcome Measure Information:
Title
Change in Individual Patients' Self-reported Overall Pain Relief Scores Before and After the Treatment Period
Description
Compare individual patients' self-reported 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)
Title
Change in Neuropathic Pain Scores in and Between Study Arms Using the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.
Description
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.
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)
Title
Differences in Pain Interference Between Study Arms Using the Brief Pain Inventory and the FACT-Taxane
Description
Compare the pain interference scores after study treatment 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)
Title
Change in the Amount of Opioid Medication Used by Patients in Each Arm Before and After Study Treatment
Description
Record the amount of opioid medication used by patients in each arm before and after the study 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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Paice, PhD, RN
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jamie Von Roenn, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
University of Wisconsin School of Medicine
City
Madison
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

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

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