Étude Pilote DEXEL-RH: Comparaison de Deux schémas Posologiques de DEXaméthasone en prévention Des Réactions d'Hypersensibilité au paclitaXEL
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.
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Quality of life assessed by the self-administered quality of life core questionnaire (QLQ-C30) version 3.0 from the European Organisation for Research and Treatment in Cancer (EORTC)
Comparison of the scores according to the EORTC Scoring Manual.
Day before chemotherapy (Day 0) of the first cycle of chemotherapy
Vanessa Samouelian, M.D., Ph. D.
Canada: Health Canada