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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Treatments: Albumin-Bound Paclitaxel; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Paclitaxel

Criteria

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).