Feasibility of a Clinical Trial Comparing the Use of Cetirizine to Replace Diphenhydramine in the Prevention of Reactions Related to Paclitaxel
- Conditions
- Lung CancerOvarian CancerBreast CancerOesophageal CancerHead Cancer NeckCervical CancerEndometrial Cancer
- Interventions
- Registration Number
- NCT04237090
- Lead Sponsor
- Ciusss de L'Est de l'Île de Montréal
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cetirizine + placebo Cetirizine 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. Diphenhydramine + placebo Lactose pill 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. Cetirizine + placebo Sodium chloride 0.9% 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. Diphenhydramine + placebo Diphenhydramine 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.
- Primary Outcome Measures
Name Time Method Change from baseline of drowsiness on Stanford Sleepiness Scale 1 hour after the administration of diphenhydramine 15 minutes before the administration of diphenhydramine. 1 hour after the administration of diphenhydramine. For treatment 1 and treatment 2
Change from baseline of drowsiness on Stanford Sleepiness Scale upon arrival at home 15 minutes before the administration of diphenhydramine. Upon arrival at home. For treatment 1 and treatment 2
Change from baseline of drowsiness on Stanford Sleepiness Scale the morning after the administration of diphenhydramine 15 minutes before the administration of diphenhydramine. Morning of day 2. For treatment 1 and treatment 2
Recruitment rate accomplished to recruit 24 participants for which a first dose of paclitaxel was administered between February and September 2020. Through study completion, 8 months Number of participants per month recruited for which a first dose of paclitaxel was administered
Percentage of participants recruited, randomized and having received the first treatment of paclitaxel planned in the study between February and September 2020 following an assessment of their eligibility. Through study completion, 8 months Number of participants recruited, randomized and having received the first treatment of paclitaxel planned in the study divided by the number of participants eligible to participate in the study
- Secondary Outcome Measures
Name Time Method Proportion of participants per group who required stopping the infusion and/or using rescue medication. Day 1 Stopping the infusion and using rescue medication defined by the medical choice of the attending physician. For treatment 1 and treatment 2.
Infusion-related reactions grade according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 classification Day 1 Grades will be determined using nurses notes. For treatment 1 and treatment 2
Trial Locations
- Locations (1)
CIUSSS de l'Est-de-l'île-de-Montréal
🇨🇦Montréal, Quebec, Canada