Pain Clinical Trial
Official title:
A Phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
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.
OBJECTIVES:
Primary
- Determine the efficacy of duloxetine hydrochloride in cancer patients with painful
chemotherapy-induced (taxane or platinum agent) peripheral neuropathy.
Secondary
- Determine the influence of this drug on peripheral neuropathy-related functional status
and quality of life of these patients.
- Describe the differences in duloxetine hydrochloride efficacy when used to treat pain
caused by chemotherapy-induced peripheral neuropathy based on the neurotoxic drug and
class.
OUTLINE: This is a randomized, double-blind, placebo-controlled, crossover study. Patients
are stratified according to prior neurotoxic agent (paclitaxel vs oxaliplatin vs other
taxane agents without paclitaxel vs platinum agents [cisplatin] without oxaliplatin) and
high risk for developing painful chemotherapy-induced peripheral neuropathy (no vs yes).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: 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.
- Arm II: 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.
Patients complete pain and quality of life questionnaires, including the BPI-SF once weekly
and FACT/GOG-NTX and EORTC QLQ-C30 questionnaires, in weeks 1, 6, 8, and 13.
After completion of study treatment, patients are followed for 2 weeks.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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