Phase 3
Completed N=231
Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
Neurotoxicity · Postoperative Pain · peripheral neuropathy · Unspecified Adult Solid Tumor, Protocol Specific
Source: ClinicalTrials.gov NCT00489411 ↗
Enrolled (actual)
231
Serious AEs
1.9%
Results posted
Apr 2017
Primary outcomePrimary: Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item — 1.06; 0.34 units on a scale — p=0.003
◆ Published Evidence
Highly cited
994citations · ~76 / year
Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial.
Summary
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.
Linked Publications (2)
-
Effect of duloxetine on pain, function, and quality of life among patients with chemotherapy-induced painful peripheral neuropathy: a randomized clinical trial.
-
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item |
1.06; 0.34 | 0.003 sig |
| SECONDARY Change in Pain-related Functional Interference Score From Week 1 to Week 5, as Measured by the BPI-SF Interference Score |
7.9; 3.5 | — |
| SECONDARY Change in the Total Score of the FACT/COG-NTX From Week 1 to Week 5 |
2.44; 0.87 | 0.03 sig |
| SECONDARY Change in Average Pain From Week 8 to Week 12, as Measured by the BPI-SF Average Pain Severity Item |
0.41; 1.42 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00489411) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.