Clinical trial · Interventional
Gabapentin in Treating Peripheral Neuropathy in Cancer Patients Undergoing Chemotherapy
The Efficacy Of Gabapentin In The Management Of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind, Placebo-Controlled, Crossover Trial
NCT00027963CI-TRIAL-00022827completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neurotoxicity | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gabapentin | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- gabapentin
- description
- 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. Quality of life is assessed at baseline and then at the end of weeks 6, 8, and 14.
- interventionNames
- Drug: gabapentin
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- 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.
- interventionNames
- Other: placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 neuropathyReferences
Publications (1)
- RESULTRao RD, Michalak JC, Sloan JA, Loprinzi CL, Soori GS, Nikcevich DA, Warner DO, Novotny P, Kutteh LA, Wong GY; North Central Cancer Treatment Group. Efficacy of gabapentin in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled, crossover trial (N00C3). Cancer. 2007 Nov 1;110(9):2110-8. doi: 10.1002/cncr.23008. PMID 17853395