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Trial record 55 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

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

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Neurotoxicity
Pain
Breast Cancer
Interventions Drug: D-cycloserine
Other: Placebo
Enrollment 7
Recruitment Details Opened in 02/2006 (2-arm design with a 4 week treatment period). The 1st patient enrolled in 05/2006; 7 patients enrolled before it was suspended in 04/2007 pending revision (new 3-arm design & 12 week treatment period). Re-opened in 09/2007, but drug manufacturing & funding issues forced it to terminate with no further accrual in 05/2008.
Pre-assignment Details  
Arm/Group Title D-cycloserine 250mg Placebo (Original Version) D-cycloserine 200mg D-cycloserine 50 mg Placebo (Revised Version)
Hide Arm/Group 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. Placebo administered orally at a dose of 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. Placebo administered orally at a dose of twice per day for 12 weeks.
Period Title: Original Version (2 Arms & 4 Weeks)
Started 4 3 0 [1] 0 [1] 0 [1]
Received an Intervention 3 3 0 0 0
Completed 4 Week Intervention 3 3 0 0 0
Completed 3 3 0 0 0
Not Completed 1 0 0 0 0
Reason Not Completed
Never received drug             1             0             0             0             0
[1]
This arm not part of the original version.
Period Title: Revised Version (3 Arms & 12 Weeks)
Started 0 [1] 0 [1] 0 0 0
Completed 0 0 0 0 0
Not Completed 0 0 0 0 0
[1]
This arm was not a part of the revised study design.
Arm/Group Title All Participants (Original Version)
Hide Arm/Group Description All 7 patients enrolled were during the original version of the study design (2 arms: d-cycloserine 250mg vs. placebo - twice daily for 4 weeks). Since the study went on to change design and then terminate prior to completing accrual, it is not useful to report baseline measures by the original arms/groups.
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 7 participants
40-50 years 1
51-60 years 2
61-70 years 4
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
3
  42.9%
Male
4
  57.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
1.Primary Outcome
Title Difference in Patient-reported Pain Intensity Scores Between the 3 Arms After the Treatment Period Using the Brief Pain Inventory
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.
Arm/Group Title D-cycloserine 250mg Placebo (Original Version) D-cycloserine 200mg D-cycloserine 50 mg Placebo (Revised Version)
Hide Arm/Group 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.
Placebo administered orally at a dose of 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.
Placebo administered orally at a dose of twice per day for 4 weeks.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change in Individual Patients' Self-reported Overall Pain Relief Scores Before and After the Treatment Period
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.
Arm/Group Title D-cycloserine 250mg Placebo (Original Version) D-cycloserine 200mg D-cycloserine 50 mg Placebo (Revised Version)
Hide Arm/Group 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.
Placebo administered orally at a dose of 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.
Placebo administered orally at a dose of twice per day for 4 weeks.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change in Neuropathic Pain Scores in and Between Study Arms Using the Neuropathic Pain Inventory, the FACT-Taxane, and the Leonard Scale.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.
Arm/Group Title D-cycloserine 250mg Placebo (Original Version) D-cycloserine 200mg D-cycloserine 50 mg Placebo (Revised Version)
Hide Arm/Group 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.
Placebo administered orally at a dose of 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.
Placebo administered orally at a dose of twice per day for 4 weeks.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Differences in Pain Interference Between Study Arms Using the Brief Pain Inventory and the FACT-Taxane
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.
Arm/Group Title D-cycloserine 250mg Placebo (Original Version) D-cycloserine 200mg D-cycloserine 50 mg Placebo (Revised Version)
Hide Arm/Group 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.
Placebo administered orally at a dose of 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.
Placebo administered orally at a dose of twice per day for 4 weeks.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change in the Amount of Opioid Medication Used by Patients in Each Arm Before and After Study Treatment
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
No patients were analyzed for this outcome measure due to a change in study design followed by early termination of the study.
Arm/Group Title D-cycloserine 250mg Placebo (Original Version) D-cycloserine 200mg D-cycloserine 50 mg Placebo (Revised Version)
Hide Arm/Group 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.
Placebo administered orally at a dose of 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.
Placebo administered orally at a dose of twice per day for 4 weeks.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo (Original Version) D-cycloserine 250mg
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Placebo (Original Version) D-cycloserine 250mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Original Version) D-cycloserine 250mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo (Original Version) D-cycloserine 250mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
Early termination resulted from a change in funding source (which ultimately fell through) along with drug manufacturing delays. Data could not be analyzed based on only 7 patients, all of whom were enrolled under the original design version.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Research Office
Organization: Northwestern University
Phone: 312-695-1301
EMail: cancertrials@northwestern.edu
Layout table for additonal information
Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00301080     History of Changes
Other Study ID Numbers: NU 05CC2
504-038 ( Other Identifier: Northwestern University IRB )
First Submitted: March 8, 2006
First Posted: March 10, 2006
Results First Submitted: November 25, 2013
Results First Posted: December 2, 2013
Last Update Posted: December 2, 2013