Ignite Creation Date:
2024-05-06 @ 1:48 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04137107
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2019-10-22
Brief Title:
Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy A Randomized Double-Blind Placebo-Controlled Phase II to Phase III Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
This phase IIIII trial studies the best dose of duloxetine and how well it works in preventing pain tingling and numbness peripheral neuropathy caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy
Detailed Description:
The primary and secondary objectives of the study
PRIMARY OBJECTIVES
I To determine the dosage of duloxetine hydrochloride duloxetine 30 mg or 60 mg daily that appears most promising in preventing oxaliplatin-induced peripheral neuropathy OIPN Phase II
II To demonstrate that the most promising dosage of duloxetine identified in the Phase II component is more effective than placebo at preventing OIPN sensory symptoms Phase III
III To demonstrate that the most promising dosage of duloxetine identified in the Phase II component is more effective than placebo at preventing oxaliplatin-induced chronic neuropathic pain Phase III
SECONDARY OBJECTIVES
I To characterize toxicity in each arm including duloxetine side effects of nausea dry mouth dizziness somnolence fatigue and insomnia using Common Terminology Criteria for Adverse Events CTCAE version v 50 Phase II
II To compare the serially measured OIPN total sensory neuropathy scores calculated from the six individual Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 QLQ-CIPN20 questions that quantify numbness tingling and pain in the fingers or hands and toes or feet measured on day 1 of each cycle of oxaliplatin treatment and at 1 month post-oxaliplatin treatment between the most promising dosage of duloxetine identified in the Phase II component and placebo Phase III
III To compare the serially measured Brief Pain Inventory Short Form BPI-SF patient-reported on the average pain scores measured on day 1 of each cycle of oxaliplatin treatment and at 1 month post-oxaliplatin treatment between the most promising dosage of duloxetine identified in the Phase II component and placebo
IV To characterize toxicity in each arm including duloxetine side effects of nausea dry mouth dizziness somnolence fatigue and insomnia using the CTCAE v 50 Phase III
OUTLINE
PHASE II Patients are randomized to 1 of 3 arms
ARM I Patients in Phase II receive duloxetine hydrochloride 30 mg 1 duloxetine capsule orally PO once daily QD during week 1 duloxetine hydrochloride 30 mg 1 duloxetine capsule PO QD and placebo 1 placebo capsule PO QD during weeks 2-16 followed by duloxetine hydrochloride 30 mg 1 duloxetine capsule PO QD during week 17 in the absence of unacceptable toxicity
ARM II Patients in Phase II receive duloxetine hydrochloride 30 mg 1 duloxetine capsule orally PO once daily QD during week 1 duloxetine hydrochloride 60 mg 2 duloxetine capsules PO QD during weeks 2-16 followed by duloxetine hydrochloride 30 mg 1 duloxetine capsule PO QD during week 17 in the absence of unacceptable toxicity
ARM III Patients in Phase II receive placebo 1 placebo capsule orally PO once daily QD during week 1 placebo 2 placebo capsules PO QD weeks 2-16 followed by placebo 1 placebo capsule PO QD during week 17 in the absence of unacceptable toxicity
PHASE III Patients are randomized to 1 of 2 arms
ARM I Patients in Phase III receive most promising dose of duloxetine hydrochloride from Phase II PO QD in the absence of unacceptable toxicity
ARM II Patients in Phase III receive placebo PO QD in the absence of unacceptable toxicity
NOTE Patients in all arms receive standard of care oxaliplatin during weeks 1-12
After completion of study patients are followed up at 30 days and at 3 6 12 and 18 months after last oxaliplatin treatment
PRIMARY OBJECTIVES
I To determine the dosage of duloxetine hydrochloride duloxetine 30 mg or 60 mg daily that appears most promising in preventing oxaliplatin-induced peripheral neuropathy OIPN Phase II
II To demonstrate that the most promising dosage of duloxetine identified in the Phase II component is more effective than placebo at preventing OIPN sensory symptoms Phase III
III To demonstrate that the most promising dosage of duloxetine identified in the Phase II component is more effective than placebo at preventing oxaliplatin-induced chronic neuropathic pain Phase III
SECONDARY OBJECTIVES
I To characterize toxicity in each arm including duloxetine side effects of nausea dry mouth dizziness somnolence fatigue and insomnia using Common Terminology Criteria for Adverse Events CTCAE version v 50 Phase II
II To compare the serially measured OIPN total sensory neuropathy scores calculated from the six individual Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 QLQ-CIPN20 questions that quantify numbness tingling and pain in the fingers or hands and toes or feet measured on day 1 of each cycle of oxaliplatin treatment and at 1 month post-oxaliplatin treatment between the most promising dosage of duloxetine identified in the Phase II component and placebo Phase III
III To compare the serially measured Brief Pain Inventory Short Form BPI-SF patient-reported on the average pain scores measured on day 1 of each cycle of oxaliplatin treatment and at 1 month post-oxaliplatin treatment between the most promising dosage of duloxetine identified in the Phase II component and placebo
IV To characterize toxicity in each arm including duloxetine side effects of nausea dry mouth dizziness somnolence fatigue and insomnia using the CTCAE v 50 Phase III
OUTLINE
PHASE II Patients are randomized to 1 of 3 arms
ARM I Patients in Phase II receive duloxetine hydrochloride 30 mg 1 duloxetine capsule orally PO once daily QD during week 1 duloxetine hydrochloride 30 mg 1 duloxetine capsule PO QD and placebo 1 placebo capsule PO QD during weeks 2-16 followed by duloxetine hydrochloride 30 mg 1 duloxetine capsule PO QD during week 17 in the absence of unacceptable toxicity
ARM II Patients in Phase II receive duloxetine hydrochloride 30 mg 1 duloxetine capsule orally PO once daily QD during week 1 duloxetine hydrochloride 60 mg 2 duloxetine capsules PO QD during weeks 2-16 followed by duloxetine hydrochloride 30 mg 1 duloxetine capsule PO QD during week 17 in the absence of unacceptable toxicity
ARM III Patients in Phase II receive placebo 1 placebo capsule orally PO once daily QD during week 1 placebo 2 placebo capsules PO QD weeks 2-16 followed by placebo 1 placebo capsule PO QD during week 17 in the absence of unacceptable toxicity
PHASE III Patients are randomized to 1 of 2 arms
ARM I Patients in Phase III receive most promising dose of duloxetine hydrochloride from Phase II PO QD in the absence of unacceptable toxicity
ARM II Patients in Phase III receive placebo PO QD in the absence of unacceptable toxicity
NOTE Patients in all arms receive standard of care oxaliplatin during weeks 1-12
After completion of study patients are followed up at 30 days and at 3 6 12 and 18 months after last oxaliplatin treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| NCI-2019-04727 | REGISTRY | NCI Clinical Trial Reporting Program | None |