NCT04237090

Feasibility of a Clinical Trial Comparing the Use of Cetirizine to Replace Diphenhydramine in the Prevention of Reactions Related to Paclitaxel

Feasibility of a Randomized Controlled Clinical Trial Comparing the Use of Cetirizine to Replace Diphenhydramine in the Prevention of Reactions Related to Paclitaxel

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Ciusss de L'Est de l'Île de Montréal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Explore the randomized, controlled, double-blind design targeted for the final clinical trial to assess the acceptability of interventions and clinical outcome measures and to provide data making it possible to estimate the parameters necessary for the preparation, modification or even abandonment of the final study.

Detailed description

Paclitaxel is known to cause 30 to 40% of infusion-related reactions when no premedication is administered. It is agreed that all patients should receive premedication with dexamethasone, an H1 antagonist, such as diphenhydramine, and an H2 antagonist before the administration of paclitaxel. There are several cases where undesirable effects (eg. drowsiness, dry mouth, motor impatience) have been reported following the administration of this conventional premedication. Diphenhydramine is often accused because of its pharmacological properties. A definitive, randomized, double-blind, non-inferiority study can assess whether cetirizine, a non-sedating H1 antagonist, can be used as an effective and safe alternative to diphenhydramine in the prevention of paclitaxel infusion-related reactions. In the current proposed feasibility study, patients will be followed for the first two doses of paclitaxel. The goal is to explore the randomized, controlled, double-blind design targeted for the final clinical trial to assess the acceptability of interventions and clinical outcome measures and to provide data making it possible to estimate the parameters necessary for the preparation, modification or even abandonment of the final study.

Conditions

• Breast Cancer
• Lung Cancer
• Ovarian Cancer
• Oesophageal Cancer
• Head Cancer Neck
• Cervical Cancer
• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Diphenhydramine	Drug identification number : 02369567
DRUG	Cetirizine	Drug identification number : 02231603
DRUG	Lactose pill	Natural product number : 00501190
DRUG	Sodium chloride 0.9%	Drug identification number : 00037796

Timeline

• Start date: 2020-02-14
• Primary completion: 2020-08-28
• Completion: 2020-09-04
• First posted: 2020-01-22
• Last updated: 2020-10-12

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study