D-Cycloserine in Treating Cancer Patients With Peripheral Neuropathy Caused by Chemotherapy - Full Text View

Sponsors and Collaborators:	Robert H. Lurie Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00301080

Purpose

RATIONALE: 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.

PURPOSE: This randomized clinical trial is studying D-cycloserine to see how well it works compared to a placebo in treating cancer patients with peripheral neuropathy caused by chemotherapy.

Condition	Intervention
Cancer-Related Problem/Condition Pain Unspecified Adult Solid Tumor, Protocol Specific	Drug: D-cycloserine

MedlinePlus related topics: Cancer Peripheral Nerve Disorders

Drug Information available for: Cycloserine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title:	D-Cycloserine in the Management of Chemotherapy-Induced Peripheral Neuropathic Pain

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Compare self reported pain intensity score between the control and placebo groups by brief pain inventory twice weekly

Secondary Outcome Measures:

Self reported pain relief score by brief pain inventory twice weekly
Neuropathic pain scale differences in and between groups by neuropathic pain index twice weekly
Compare pain interference between groups by interference scale of the brief pain inventory twice weekly
Compare the reduction of opioid medication use between groups by opioid equivalents

Estimated Enrollment:	60
Study Start Date:	February 2006
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Compare the self-reported pain intensity in cancer patients receiving chemotherapy or anticancer drugs treated with D-cycloserine vs placebo.
Compare the efficacy of these regimens, in terms of reducing pain of chronic chemotherapy-induced peripheral neuropathy.

Secondary

Compare the self-reported pain relief score in patients treated with these drugs.
Compare the change in neuropathic pain scales in patients treated with these drugs.
Compare the pain interference in patients treated with these drugs.
Compare the reduction of opioid medication in patients treated with these drugs.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral D-cycloserine twice daily.
Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for up to 4 weeks in the absence of unacceptable toxicity. Patients may continue to receive medication off-study at the discretion of their regular oncologist or primary physician.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Moderate to severe chronic peripheral neuropathic pain*, meeting the following criteria:
- Primarily involving the feet
- Worst daily pain severity level ≥ 5 on a 0-10 pain scale (self-reported)
- Secondary to chemotherapy or anticancer drug treatments NOTE: *Chronic peripheral neuropathic pain defined as bilateral pain ≥ 1 month in duration which began in association with chemotherapy
Diagnosis of any malignant cancer at any stage
No secondary cause of neuropathic pain, including any of the following:
- HIV/AIDS
- Traumatic injury
- Personal history of non-chemotherapy-induced neuropathy

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Creatinine clearance ≥ 80 mL/min
Not pregnant or nursing
Fertile patients must use effective contraception
No history of seizures
No history of psychosis, major depression, or severe anxiety based on the Edmonton Symptom Assessment Scale
Diabetes mellitus (type 1 or 2) allowed if no pre-existing neuropathy
Ability to read and speak English

PRIOR CONCURRENT THERAPY:

Concurrent chronic adjuvant pain medication (e.g., antidepressant) allowed if dose is stable for at least 1 week prior to study entry
Concurrent chemotherapy allowed if agents are not known to cause a peripheral neuropathy
Concurrent opioids allowed if properly monitored during study treatment
No concurrent antibiotic therapy for tuberculosis (e.g., isoniazid)
No concurrent anticonvulsant medication (e.g., gabapentin or carbamazepine)
- Must taper off medication prior to study entry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301080

Locations

United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013

Sponsors and Collaborators

Robert H. Lurie Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:	Jamie Hayden Von Roenn, MD	Robert H. Lurie Cancer Center
Investigator:	Toby C. Campbell, MD	University of Wisconsin, Madison

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000456775, NU-05CC2, NU-0504-038
Study First Received:	March 8, 2006
Last Updated:	December 20, 2008
ClinicalTrials.gov Identifier:	NCT00301080
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

pain
neurotoxicity
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Cycloserine
Neuromuscular Diseases
Neurotoxicity Syndromes

Peripheral Nervous System Diseases
Neurotoxicity syndromes
Pain

Additional relevant MeSH terms:

Antimetabolites
Anti-Bacterial Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Nervous System Diseases

Anti-Infective Agents, Urinary
Antitubercular Agents
Renal Agents
Pharmacologic Actions
Antibiotics, Antitubercular

ClinicalTrials.gov processed this record on January 15, 2009