- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00301080
D-cycloserine in the Management of Chemotherapy-Induced Peripheral Neuropathic Pain
A Phase III Study of D-Cycloserine in the Management of Paclitaxel-Induced Peripheral Neuropathic Pain in Breast Cancer Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611-3013
- Northwestern University
-
-
Wisconsin
-
Madison, Wisconsin, United States
- University of Wisconsin School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo (original version)
Placebo administered orally twice per day for 4 weeks.
|
|
ACTIVE_COMPARATOR: D-cycloserine 200mg
D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
|
Other Names:
|
ACTIVE_COMPARATOR: D-cycloserine 50 mg
D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
|
Other Names:
|
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.
|
Other Names:
|
PLACEBO_COMPARATOR: Placebo (revised version)
Placebo administered orally twice per day for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
|
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.
|
From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
|
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.
|
From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
|
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.
|
From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jamie Von Roenn, MD, Northwestern University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Nervous System Diseases
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Pain
- Neurologic Manifestations
- Breast Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Poisoning
- Breast Neoplasms
- Neuralgia
- Neurotoxicity Syndromes
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antimetabolites
- Anti-Bacterial Agents
- Antitubercular Agents
- Antibiotics, Antitubercular
- Anti-Infective Agents, Urinary
- Renal Agents
- Cycloserine
Other Study ID Numbers
- NU 05CC2
- 504-038 (OTHER: Northwestern University IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dr. Negrin University HospitalRecruitingPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
Cairo UniversityCompletedCervical Pain | Lumbar Pain SyndromeEgypt
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States