Status:
COMPLETED
Comparison of Two Regimens of Dexamethasone in the Prevention of Hypersensitivity Reactions to Paclitaxel, a Pilot Study
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Prevention of Hypersensitivity Reactions to Paclitaxel
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01797991
Start Date
February 1 2013
End Date
August 1 2013
Last Update
October 31 2013
Active Locations (1)
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1
Oncology oupatient clinic and oncology unit; CHUM Notre-Dame Hospital
Montreal, Quebec, Canada