Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy
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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 3 |
| 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:
- Determine whether gabapentin improves the pain and other symptoms in cancer patients with chemotherapy-induced peripheral neuropathy.
- Determine the effect of this drug on symptom distress, mood states, functional abilities, and overall quality of life in these patients.
- Determine the toxic effects of this drug in these patients.
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.
- Arm I: Patients receive titrating doses of oral gabapentin twice daily and then three times daily for 3 weeks. Patients then receive a fixed dose of oral gabapentin three times daily for 3 weeks. Patients cross-over to therapy as in arm II at week 8.
- Arm II: Patients receive titrating doses of oral placebo and then a fixed dose of oral placebo as in arm I. Patients cross-over to therapy as in arm I at week 8.
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:
- Has received or is currently receiving neurotoxic chemotherapy, including taxanes (e.g., paclitaxel or docetaxel), platinum-based compounds (e.g., carboplatin, cisplatin, or oxaliplatin), or vinca alkaloids (e.g., vincristine or vinblastine)
Pain or symptoms of peripheral neuropathy of at least 1 month duration attributed to chemotherapy-induced peripheral neuropathy
- Average daily pain rating of at least 4 out of 10 using the pain numerical rating scale (where 0 is no pain and 10 is the worst pain possible) OR
Evidence of peripheral neuropathy of at least grade 1 out of 3 by ECOG Common
- Toxicity Criteria for sensory neuropathy
No other identified causes of painful paresthesia existing prior to chemotherapy
- No radiotherapy-induced or malignant plexopathy
- No lumbar or cervical radiculopathy
No pre-existing peripheral neuropathy of another etiology, including:
- B12 deficiency
- AIDS
- Monoclonal gammopathy
- Diabetes
- Heavy metal poisoning
- Amyloidosis
- Syphilis
- Hyperthyroidism or hypothyroidism
- Inherited neuropathy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Not specified
Life expectancy:
- At least 6 months
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Creatinine no greater than 1.5 times upper limit of normal
Other:
- No prior allergic reaction or intolerance to gabapentin
- No significant psychiatric illness (e.g., mania, psychosis, or schizophrenia) that would preclude study compliance
- No extreme difficulty swallowing pills
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- Not specified
Other:
- More than 30 days since prior investigational agent for pain control
- Concurrent selective serotonin reuptake inhibitors allowed
- Concurrent nonsteroidal anti-inflammatory drugs allowed
- No concurrent tricyclic antidepressant (e.g., amitriptyline, nortriptyline, or desipramine)*
- No concurrent monoamine oxidase inhibitor*
- No concurrent opioid analgesic*
- No other concurrent adjuvant analgesic (e.g., anticonvulsant, clonazepam, or mexiletine)*
- No concurrent topical analgesics (e.g., lidocaine gel or lidocaine patch)*
- No concurrent amifostine
- No concurrent investigational agent for pain control NOTE: * For pain or symptoms due to chemotherapy-induced peripheral neuropathy
Contacts and Locations
Show 23 Study Locations| Study Chair: | Charles L. Loprinzi, MD | Mayo Clinic |
More Information
Additional Information:
Publications:
| 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 |
Keywords provided by National Cancer Institute (NCI):
|
neurotoxicity pain |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 23, 2013