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

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ClinicalTrials.gov Identifier: NCT04237090
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Matthieu Picard, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Lung Cancer Ovarian Cancer Oesophageal Cancer Head Cancer Neck Cervical Cancer Endometrial Cancer Drug: Diphenhydramine Drug: Cetirizine Drug: Lactose pill Drug: Sodium chloride 0.9% Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Feasibility of a Randomized Controlled Clinical Trial Comparing the Use of Cetirizine to Replace Diphenhydramine in the Prevention of Reactions Related to Paclitaxel
Estimated Study Start Date : February 14, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020


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 Name: Benadryl

Drug: Lactose pill
Natural product number : 00501190

Experimental: Cetirizine + placebo

Cetirizine tablet 100 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 Name: Reactine

Drug: Sodium chloride 0.9%
Drug identification number : 00037796




Primary Outcome Measures :
  1. Mean 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

  2. Mean 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

  3. Mean 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. 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.

  2. 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


Other Outcome Measures:
  1. 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

  2. Reasons of loss to follow-up using a home-made questionnaire [ Time Frame: Day 1 ]
    For treatment 1 and treatment 2

  3. Maintenance of the blind in participants using a home-made questionnaire [ Time Frame: Day 1 ]
    At the end of paclitaxel infusion of treatment 2

  4. 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

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04237090


Contacts
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Contact: Matthieu Picard, M.D. 1-514-252-3400 ext 5021 mpicard.hmr@ssss.gouv.qc.ca
Contact: Philippe Bouchard, B.Pharm. 1-514-252-4300 ext 1602 pbouchard1.hmr@ssss.gouv.qc.ca

Locations
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Canada, Quebec
CIUSSS de l'Est-de-l'île-de-Montréal Recruiting
Montréal, Quebec, Canada, H1T 2M4
Contact: Matthieu Picard, MD    514-252-3400 ext 5021    mpicard.hmr@ssss.gouv.qc.ca   
Sponsors and Collaborators
Ciusss de L'Est de l'Île de Montréal
Investigators
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Principal Investigator: Matthieu Picard, M.D. Ciusss de L'Est de l'Île de Montréal

Publications:
Siderov J, Wendel N, Davis ID. Non-Sedating Antihistamines for Premedication in Ambulatory Oncology Patients. Journal of Pharmacy Practice and Research 2002; 32(2): 108-9.

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Responsible Party: Matthieu Picard, Assitant clinical professor, Ciusss de L'Est de l'Île de Montréal
ClinicalTrials.gov Identifier: NCT04237090    
Other Study ID Numbers: 2020-2110
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Endometrial Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Neoplasms
Uterine Diseases
Diphenhydramine
Promethazine
Cetirizine
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents