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

October 8, 2020 updated by: Matthieu Picard, Ciusss de L'Est de l'Île de Montréal

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H1T 2M4
        • CIUSSS de l'Est-de-l'Île-de-Montréal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diphenhydramine + placebo

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.
Drug: Diphenhydramine
Drug identification number : 02369567
Other Names:
  • Benadryl
Drug: Lactose pill
Natural product number : 00501190
Experimental: Cetirizine + placebo

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.
Drug: Cetirizine
Drug identification number : 02231603
Other Names:
  • Reactine
Drug: Sodium chloride 0.9%
Drug identification number : 00037796

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of drowsiness on Stanford Sleepiness Scale 1 hour after the administration of diphenhydramine
Time Frame: 15 minutes before the administration of diphenhydramine. 1 hour after the administration of diphenhydramine.
For treatment 1 and treatment 2
15 minutes before the administration of diphenhydramine. 1 hour after the administration of diphenhydramine.
Change from baseline of drowsiness on Stanford Sleepiness Scale upon arrival at home
Time Frame: 15 minutes before the administration of diphenhydramine. Upon arrival at home.
For treatment 1 and treatment 2
15 minutes before the administration of diphenhydramine. Upon arrival at home.
Change from baseline of drowsiness on Stanford Sleepiness Scale the morning after the administration of diphenhydramine
Time Frame: 15 minutes before the administration of diphenhydramine. Morning of day 2.
For treatment 1 and treatment 2
15 minutes before the administration of diphenhydramine. Morning of day 2.
Recruitment rate accomplished to recruit 24 participants for which a first dose of paclitaxel was administered between February and September 2020.
Time Frame: Through study completion, 8 months
Number of participants per month recruited for which a first dose of paclitaxel was administered
Through study completion, 8 months
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.
Time Frame: 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
Through study completion, 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants per group who required stopping the infusion and/or using rescue medication.
Time Frame: Day 1
Stopping the infusion and using rescue medication defined by the medical choice of the attending physician. For treatment 1 and treatment 2.
Day 1
Infusion-related reactions grade according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 classification
Time Frame: Day 1
Grades will be determined using nurses notes. For treatment 1 and treatment 2
Day 1

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants who completed the study
Time Frame: Through the course of the study, 8 months
Number of participants who will have completed the study in each group divided by the number of participants recruited in each group
Through the course of the study, 8 months
Reasons of loss to follow-up using a home-made questionnaire
Time Frame: Day 1
For treatment 1 and treatment 2
Day 1
Maintenance of the blind in participants using a home-made questionnaire
Time Frame: Day 1
At the end of paclitaxel infusion of treatment 2
Day 1
Maintenance of the blind in nurses using a home-made questionnaire
Time Frame: Day 1
At the end of paclitaxel infusion of treatment 1 and 2
Day 1
Side effects experienced by participants using a home-made questionnaire
Time Frame: Day 2
Focus on drowsiness, dry mouth, eyes or nose, dizziness and restlessness/excitement. For treatment 1 and treatment 2.
Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ciusss de L'Est de l'Île de Montréal

Investigators

  • Principal Investigator: Matthieu Picard, M.D., Ciusss de L'Est de l'Île de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2020

Primary Completion (Actual)

August 28, 2020

Study Completion (Actual)

September 4, 2020

Study Registration Dates

First Submitted

January 17, 2020

First Submitted That Met QC Criteria

January 17, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

October 12, 2020

Last Update Submitted That Met QC Criteria

October 8, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-2110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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