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

NCT00301080 | Terminated Phase 3 Results DMC

• 2 other identifiers: NU 05CC2504-038
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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.

Conditions

Neurotoxicity; Pain; Breast Cancer

Keywords

pain; neurotoxicity; breast cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)

Secondary Outcomes (4)

• Change in Individual Patients' Self-reported Overall 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.

  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

  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

  From the date that the first patient is registered until the last patient completes the 12 weeks of study intervention (approximately 1 year)

Study Arms (5)

Placebo (original version)

PLACEBO COMPARATOR

Placebo administered orally twice per day for 4 weeks.

Other: Placebo

D-cycloserine 200mg

ACTIVE COMPARATOR

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

Drug: D-cycloserine

D-cycloserine 50 mg

ACTIVE COMPARATOR

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

Drug: D-cycloserine

D-cycloserine 250mg

ACTIVE COMPARATOR

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.

Drug: D-cycloserine

Placebo (revised version)

PLACEBO COMPARATOR

Placebo administered orally twice per day for 12 weeks.

Other: Placebo

Interventions

D-cycloserine DRUG

Also known as: Cycloserine; Seromycin™

D-cycloserine 200mg; D-cycloserine 250mg; D-cycloserine 50 mg

Placebo OTHER

Placebo (original version); Placebo (revised version)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (2)

Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

University of Wisconsin School of Medicine

Madison, Wisconsin, United States

Location

MeSH Terms

Conditions

Neurotoxicity Syndromes; Pain; Breast Neoplasms

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

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.

Results Point of Contact

• Title: Clinical Research Office
• Organization: Northwestern University

cancertrials@northwestern.edu

312-695-1301

Study Officials

• Judith Paice, PhD, RN

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Jamie Von Roenn, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2006
• First Posted: March 10, 2006
• Study Start: February 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: May 1, 2008
• Last Updated: December 2, 2013
• Results First Posted: December 2, 2013

Record last verified: 2013-11

Locations

US (2)