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| Sponsor: | North Central Cancer Treatment Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00027963 |
Purpose
RATIONALE: Gabapentin may be effective in relieving pain and other symptoms of peripheral neuropathy. It is not yet known if gabapentin is effective in treating peripheral neuropathy in cancer patients undergoing chemotherapy.
PURPOSE: Randomized phase III trial to determine the effectiveness of gabapentin in treating pain and other symptoms of peripheral neuropathy in cancer patients undergoing chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Neurotoxicity Pain |
Drug: gabapentin Procedure: quality-of-life assessment |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | The Efficacy Of Gabapentin In The Management Of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind, Placebo-Controlled, Crossover Trial |
| Study Start Date: | February 2002 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to neurotoxic chemotherapy (active vs nonactive and discontinued vs completed) and neurotoxic chemotherapeutic agents (vinca alkaloids vs taxanes vs platinum-based compounds vs combination of two or more of the above agents). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline and then at the end of weeks 6, 8, and 14.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pain or symptoms of peripheral neuropathy of at least 1 month duration attributed to chemotherapy-induced peripheral neuropathy
Evidence of peripheral neuropathy of at least grade 1 out of 3 by ECOG Common
No other identified causes of painful paresthesia existing prior to chemotherapy
No pre-existing peripheral neuropathy of another etiology, including:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 23 Study Locations| Study Chair: | Charles L. Loprinzi, MD | Mayo Clinic |
More Information
| ClinicalTrials.gov Identifier: | NCT00027963 History of Changes |
| Other Study ID Numbers: | CDR0000069098, NCCTG-N00C3, NCCTG-CCC-0020, NCI-P01-0196 |
| Study First Received: | December 7, 2001 |
| Last Updated: | August 19, 2009 |
| Health Authority: | United States: Federal Government |
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neurotoxicity pain |
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Peripheral Nervous System Diseases Neurotoxicity Syndromes Neuromuscular Diseases Nervous System Diseases Poisoning Substance-Related Disorders Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents |