Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489411
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
2007-06-20
Brief Title:
Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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 FACTGOG-NTX and EORTC QLQ-C30 questionnaires in weeks 1 6 8 and 13
After completion of study treatment patients are followed for 2 weeks
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 FACTGOG-NTX and EORTC QLQ-C30 questionnaires in weeks 1 6 8 and 13
After completion of study treatment patients are followed for 2 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000553389 | REGISTRY | NCI Physician Data Query | None |
| CALGB-170601 | None | None | None |