Prevention of Hypersensitivity Reactions to Paclitaxel Clinical Trial
Official title:
Étude Pilote DEXEL-RH: Comparaison de Deux schémas Posologiques de DEXaméthasone en prévention Des Réactions d'Hypersensibilité au paclitaXEL
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention