Clinical trial · Interventional
Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
A Phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
NCT00489411CI-TRIAL-00027199completedPhase 3Results postedClinicalTrials.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: Duloxetine may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether duloxetine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy. PURPOSE: This randomized phase III trial is studying duloxetine to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.
Conditions
Conditions (4)
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 | — |
| Peripheral Neuropathy | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| duloxetine hydrochloride | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I/Group A (Duloxetine then Placebo)
- description
- Patients receive oral duloxetine hydrochloride once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive an oral placebo once or twice daily in weeks 8-13.
- interventionNames
- Drug: duloxetine hydrochloride
- Other: placebo
- type
- EXPERIMENTAL
- label
- Arm II/Group B (Placebo then Duloxetine)
- description
- Patients receive an oral placebo once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive oral duloxetine hydrochloride once or twice daily in weeks 8-13.
- interventionNames
- Drug: duloxetine hydrochloride
- Other: placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of cancer * CNS malignancy allowed with the exception of leptomeningeal carcinomatosis * Must have painful sensory chemotherapy-induced peripheral neuropathy (CIPN) resulting from prior treatment with single-agent taxane or platinum agents (paclitaxel, docetaxel, nab-paclitaxel, oxaliplatin, cisplatin) (may not have received drugs from both classes) * CIPN \> grade 1 as measured by NCI-CTCAE v 4.0 * Average neuropathic pain score ≥ 4 * Patients with the following illnesses known to cause peripheral neuropathy are eligible, provided they have no evidence of neuropathy from these illnesses: * Diabetes mellitus * Peripheral vascular disease * HIV infection * Significant degenerative or familial neurologic disorder known to cause peripheral neuropathy * No clinical or subclinical neuropathy from nerve compression injuries (i.e., carpal tunnel syndrome, brachial plexopathy, spinal stenosis, or spinal nerve root compression) PATIENT CHARACTERISTICS: * AST ≤ 3 times upper limit of normal * Total bilirubin ≤ normal * Creatinine clearance \> 30 mL/min * Not pregnant or nursing * Able to take oral or enteral medication * No history of seizure disorder * No diagnosis of ethanol addiction or dependence within the past 10 years * No history of narrow-angle glaucoma * None of the following: * History of suicidal thoughts * Symptoms of or history of schizophrenia, bipolar disease, or a major depression * Serious eating disorder such as bulimia or anorexia where electrolyte imbalance is likely PRIOR CONCURRENT THERAPY: * At least 3 months since prior and no concurrent taxane or platinum agent * At least 14 days since prior and no concurrent monoamine oxidase inhibitors or other antidepressants * No other prior or concurrent neurotoxic drugs (e.g., vincristine, vinblastine, cytarabine, thalidomide, bortezomib, carboplatin, or procarbazine) * No concurrent anticonvulsants * No concurrent B or E vitamin supplementation in doses greater than the recommended daily allowance (RDA) * Centrum (standard formula) and One-A-Day "essential" formula which contain 100% RDA for vitamins B6, E, and B12 allowed * Other multivitamins allowed provided they contain no more than 100% RDA of B vitamins and vitamin E * No concurrent treatment (pharmacologic) for depression
References
Publications (3)
- RESULTLavoie Smith EM, Pang H, Cirrincione C, et al.: CALGB 170601: A phase III double blind trial of duloxetine to treat painful chemotherapy-induced peripheral neuropathy (CIPN). [Abstract] J Clin Oncol 30 (Suppl 15): A-CRA9013, 2012.
- DERIVEDSmith EM, Pang H, Ye C, Cirrincione C, Fleishman S, Paskett ED, Ahles T, Bressler LR, Le-Lindqwister N, Fadul CE, Loprinzi C, Shapiro CL; Alliance for Clinical Trials in Oncology. Predictors of duloxetine response in patients with oxaliplatin-induced painful chemotherapy-induced peripheral neuropathy (CIPN): a secondary analysis of randomised controlled trial - CALGB/alliance 170601. Eur J Cancer Care (Engl). 2017 Mar;26(2):10.1111/ecc.12421. doi: 10.1111/ecc.12421. Epub 2015 Nov 25. PMID 26603828
- DERIVEDSmith EM, Pang H, Cirrincione C, Fleishman S, Paskett ED, Ahles T, Bressler LR, Fadul CE, Knox C, Le-Lindqwister N, Gilman PB, Shapiro CL; Alliance for Clinical Trials in Oncology. Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial. JAMA. 2013 Apr 3;309(13):1359-67. doi: 10.1001/jama.2013.2813. PMID 23549581