Feasibility of a Clinical Trial Comparing the Use of Cetirizine to Replace Diphenhydramine in the Prevention of Reactions Related to Paclitaxel

• Status: Completed
• Trial end date: 2020-09-04
• Target enrollment: 0
• Participant gender: All

Summary

Explore the randomized, controlled, double-blind design targeted for the final clinical trial to assess the acceptability of interventions and clinical outcome measures and to provide data making it possible to estimate the parameters necessary for the preparation, modification or even abandonment of the final study.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ciusss de L'Est de l'Île de Montréal
• Treatments: Albumin-Bound Paclitaxel; Cetirizine; Diphenhydramine; Paclitaxel; Promethazine

Criteria

Inclusion Criteria:

• Receiving intravenous chemotherapy treatments at the Maisonneuve-Rosemont hospital outpatient oncology clinic

• Starting their first lifetime treatment with paclitaxel (alone or in combination with other anticancer agents).

• Capable of giving free and informed consent and who agrees to participate by signing the consent form

• Aged 18 and over

• Able to complete questionnaires

Exclusion Criteria:

• Does not understand French or English

• Taking chronic H1 antagonist orally

• Taking chronic systemic corticosteroids

• Contraindication or possible medical danger, such as a documented allergy or previous intolerance, related to the administration of cetirizine, diphenhydramine, placebo or any ingredient in their formulation

• Has received paclitaxel, docetaxel or paclitaxel nanoparticles linked to albumin in the past

• Receiving paclitaxel nanoparticles linked to albumin

• Severe renal impairment (Cockcroft-Gault <10 milliliters/minute)

• Pregnant or breastfeeding women

• Receiving paclitaxel under desensitization protocol

• Documented or reported dysphagia or other pathophysiological condition preventing a tablet from being swallowed whole

• Interactions preventing the full dose of oral cetirizine from being absorbed

• Participating in another clinical trial simultaneously