Neurotoxicity, Pain
Conditions
Keywords
neurotoxicity, pain
Brief summary
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.
Detailed description
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.
Interventions
DRUGgabapentin
OTHERplacebo
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 Life expectancy: * At least 6 months 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain and symptoms | Up to 14 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life | Up to 14 weeks |
Countries
Canada, United States
Outcome results
None listed