Feasibility of a Clinical Trial Comparing the Use of Cetirizine to Replace Diphenhydramine in the Prevention of Reactions Related to Paclitaxel (PREMED-F1)

Ciusss de L'Est de l'Île de Montréal

Status and phase: Completed; Phase 3

Conditions: Endometrial Cancer; Oesophageal Cancer; Breast Cancer; Head Cancer Neck; Lung Cancer; Ovarian Cancer; Cervical Cancer

Treatments: Drug: Lactose pill; Drug: Diphenhydramine; Drug: Sodium chloride 0.9%; Drug: Cetirizine

Study type: Interventional

Funder types: Other

Identifiers

NCT04237090

2020-2110

Details and patient eligibility

About

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.

Full description

Paclitaxel is known to cause 30 to 40% of infusion-related reactions when no premedication is administered. It is agreed that all patients should receive premedication with dexamethasone, an H1 antagonist, such as diphenhydramine, and an H2 antagonist before the administration of paclitaxel. There are several cases where undesirable effects (eg. drowsiness, dry mouth, motor impatience) have been reported following the administration of this conventional premedication. Diphenhydramine is often accused because of its pharmacological properties.

A definitive, randomized, double-blind, non-inferiority study can assess whether cetirizine, a non-sedating H1 antagonist, can be used as an effective and safe alternative to diphenhydramine in the prevention of paclitaxel infusion-related reactions.

In the current proposed feasibility study, patients will be followed for the first two doses of paclitaxel. The goal is to 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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27 participants in 2 patient groups

Diphenhydramine + placebo

Active Comparator group

Description:

Diphenhydramine 50 mg intravenous given in a 50 milliliters bag of sodium chloride 0.9 percent, with famotidine, 30 minutes before the paclitaxel infusion. 15 minutes infusion. Lactose tablet 100 mg per os given 30 minutes before the paclitaxel infusion.with a 180 milliliters glass of water.

Treatment:

Drug: Diphenhydramine

Drug: Lactose pill

Cetirizine + placebo

Experimental group

Description:

Cetirizine tablet 10 mg per os given 30 minutes before the paclitaxel infusion.with a 180 milliliters glass of water. 1 milliliter of sodium chloride 0,9 percent intravenous given in a 50 milliliters bag of sodium chloride 0.9 percent, with famotidine, 30 minutes before the paclitaxel infusion. 15 minutes infusion.

Treatment:

Drug: Cetirizine

Drug: Sodium chloride 0.9%