NCT01797991

Comparison of Two Regimens of Dexamethasone in the Prevention of Hypersensitivity Reactions to Paclitaxel, a Pilot Study

Étude Pilote DEXEL-RH: Comparaison de Deux schémas Posologiques de DEXaméthasone en prévention Des Réactions d'Hypersensibilité au paclitaXEL

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, unicentric, two-arm, parallel, controlled, and double blind pilot study. The purpose of this pilot study is to assess the feasibility of a trial designed to compare the quality of life of patients taking dexamethasone in two different ways to prevent hypersensitivity reactions to paclitaxel. Dexamethasone given intravenously (IV) 30 minutes before paclitaxel could improve quality of life, could adequately prevent hypersensitivity reactions to paclitaxel and could reduce adverse effects compared to dexamethasone given orally 12 hours and 6 hours before paclitaxel.

Detailed description

Primary objective: To assess the feasibility of a randomized, parallel, two-arm, controlled and double blind trial designed to compare the quality of life of patients taking dexamethasone 20 mg IV 30 minutes before paclitaxel with those taking a standard dose of dexamethasone, 20 mg orally 12 hours and 6 hours before paclitaxel, in patients taking paclitaxel every two to three weeks for a minimum of two cycles in order to estimate a sample size. Secondary objectives: Between the two study groups, to compare: * Quality of life during the first two cycles of chemotherapy; * Efficacy of dexamethasone in preventing acute hypersensitivity reactions to paclitaxel in the first two cycles of chemotherapy; * Adverse effects associated with dexamethasone on a daily basis during the first seven days of the first two cycles of chemotherapy. Eligible patients will be randomized in a 1:1 ratio to one of the two study groups.

Conditions

• Prevention of Hypersensitivity Reactions to Paclitaxel

Interventions

Type	Name	Description
DRUG	Dexamethasone per os
DRUG	Matching placebo for dexamethasone IV
DRUG	Dexamethasone IV
DRUG	Matching placebo for dexamethasone per os

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-02-25
• Last updated: 2013-10-31

Locations

1 site across 1 country: Canada