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

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.

Inclusion criteria

• Patient treated at the outpatient clinic or admitted to the oncology unit of Notre-Dame Hospital between February 4, 2013 and July 19, 2013;
• Patient diagnosed with cancer;
• Patient starting a chemotherapy containing paclitaxel every two to three weeks for a minimum of two cycles;
• Patient aged 18 years and over;
• Patient able to give free and informed consent and who agrees to participate by signing the consent form;
• Patient able to complete the questionnaire on quality of life EORTC QLQ-C30 and the personal logbook.

Exclusion criteria

• Patient unable to speak English or French;
• Patient who has previously received paclitaxel;
• Patient receiving a prescription of paclitaxel bound to albumin;
• Patient is currently under treatment with systemic corticosteroids or has received systemic corticosteroids during the last week;
• Patient in another research protocol evaluating a different chemotherapy regimen;
• Patient who had an allergic reaction to taxanes;
• Patient with severe intolerance to lactose;
• Patient with an allergy or a severe intolerance to products containing castor oil (eg.: cyclosporine and vitamin K).