Phase 3 N=231 Randomized Double-blind Supportive Care

Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

Neurotoxicity · Pain · Peripheral Neuropathy · Unspecified Adult Solid Tumor, Protocol Specific

Bottom Line

View on ClinicalTrials.gov: NCT00489411 ↗

Enrolled (actual)

231

Serious AEs

1.9%

Results posted

Apr 2017

Primary outcome: 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 units on a scale — p=0.003

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: duloxetine hydrochloride (Drug); placebo (Other)
Age: Adult, Older Adult · 25+ yrs
Sex: All
Sponsor: Alliance for Clinical Trials in Oncology
Primary completion: Jan 2012

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00489411). 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.