Clinical trial NCT04137107: Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer
Official title: Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study
Conditions: Stage II Colorectal Cancer AJCC v8
Stage III Colorectal Cancer AJCC v8
Summary: This phase II/III 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.
Interventions:
description: Given standard of care oxaliplatin
name: Oxaliplatin
type: Drug
description: Given PO
name: Duloxetine Hydrochloride
type: Drug
description: Given PO
name: Duloxetine
type: Drug
description: Ancillary studies
name: Quality-of-Life Assessment
type: Other
description: Ancillary studies
name: Questionnaire Administration
type: Other
description: Given PO
name: Placebo
type: Other
Study arms:
design_group_description: 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.
design_group_title: Phase II, Arm I (duloxetine hydrochloride, placebo)
design_group_type: Experimental
design_group_description: 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.
design_group_title: Phase II, Arm II (duloxetine hydrochloride)
design_group_type: Experimental
design_group_description: 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.
design_group_title: Phase II, Arm III (placebo)
design_group_type: Placebo Comparator
design_group_description: Patients in Phase III receive most promising dose of duloxetine hydrochloride from Phase II PO QD in the absence of unacceptable toxicity.
design_group_title: Phase III, Arm I (duloxetine hydrochloride)
design_group_type: Experimental
design_group_description: Patients in Phase III receive placebo PO QD in the absence of unacceptable toxicity.
design_group_title: Phase III, Arm II (placebo)
design_group_type: Placebo Comparator
Sponsor: Alliance Foundation Trials LLC
Collaborators: National Cancer Institute
Drug name mappings:
name: 盐酸度洛西汀
lang: CN
name: Duloxetine Hydrochloride
lang: EN
name: デュロキセチン塩酸塩
lang: JP
name: 奥沙利铂
lang: CN
name: Oxaliplatin
lang: EN
name: オキサリプラチン
lang: JP