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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)

Primary Purpose

Breast Cancer, Lung Cancer, Ovarian Cancer

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Diphenhydramine

Cetirizine

Lactose pill

Sodium chloride 0.9%

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

CIUSSS de l'Est-de-l'île-de-Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Diphenhydramine + placebo

Cetirizine + placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change from baseline of drowsiness on Stanford Sleepiness Scale 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

For treatment 1 and treatment 2

Change from baseline of drowsiness on Stanford Sleepiness Scale the morning after the administration of diphenhydramine

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.

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.

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

Proportion of participants per group who required stopping the infusion and/or using rescue medication.

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

Grades will be determined using nurses notes. For treatment 1 and treatment 2

Full Information

NCT ID

NCT04237090

First Posted

January 17, 2020

Last Updated

October 8, 2020

Sponsor

Ciusss de L'Est de l'Île de Montréal

1. Study Identification

Unique Protocol Identification Number

NCT04237090

Brief Title

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

Acronym

PREMED-F1

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

February 14, 2020 (Actual)

Primary Completion Date

August 28, 2020 (Actual)

Study Completion Date

September 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ciusss de L'Est de l'Île de Montréal

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Lung Cancer, Ovarian Cancer, Oesophageal Cancer, Head Cancer Neck, Cervical Cancer, Endometrial Cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diphenhydramine + placebo

Arm Type

Active Comparator

Arm Description

Arm Title

Cetirizine + placebo

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Diphenhydramine

Other Intervention Name(s)

Benadryl

Intervention Description

Drug identification number : 02369567

Intervention Type

Drug

Intervention Name(s)

Cetirizine

Other Intervention Name(s)

Reactine

Intervention Description

Drug identification number : 02231603

Intervention Type

Drug

Intervention Name(s)

Lactose pill

Intervention Description

Natural product number : 00501190

Intervention Type

Drug

Intervention Name(s)

Sodium chloride 0.9%

Intervention Description

Drug identification number : 00037796

Primary Outcome Measure Information:

Title

Change from baseline of drowsiness on Stanford Sleepiness Scale 1 hour after the administration of diphenhydramine

Description

For treatment 1 and treatment 2

Time Frame

15 minutes before the administration of diphenhydramine. 1 hour after the administration of diphenhydramine.

Title

Change from baseline of drowsiness on Stanford Sleepiness Scale upon arrival at home

Description

For treatment 1 and treatment 2

Time Frame

15 minutes before the administration of diphenhydramine. Upon arrival at home.

Title

Change from baseline of drowsiness on Stanford Sleepiness Scale the morning after the administration of diphenhydramine

Description

For treatment 1 and treatment 2

Time Frame

15 minutes before the administration of diphenhydramine. Morning of day 2.

Title

Recruitment rate accomplished to recruit 24 participants for which a first dose of paclitaxel was administered between February and September 2020.

Description

Number of participants per month recruited for which a first dose of paclitaxel was administered

Time Frame

Through study completion, 8 months

Title

Description

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

Time Frame

Through study completion, 8 months

Secondary Outcome Measure Information:

Title

Proportion of participants per group who required stopping the infusion and/or using rescue medication.

Description

Stopping the infusion and using rescue medication defined by the medical choice of the attending physician. For treatment 1 and treatment 2.

Time Frame

Day 1

Title

Infusion-related reactions grade according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 classification

Description

Grades will be determined using nurses notes. For treatment 1 and treatment 2

Time Frame

Day 1

Other Pre-specified Outcome Measures:

Title

Proportion of participants who completed the study

Description

Number of participants who will have completed the study in each group divided by the number of participants recruited in each group

Time Frame

Through the course of the study, 8 months

Title

Reasons of loss to follow-up using a home-made questionnaire

Description

For treatment 1 and treatment 2

Time Frame

Day 1

Title

Maintenance of the blind in participants using a home-made questionnaire

Description

At the end of paclitaxel infusion of treatment 2

Time Frame

Day 1

Title

Maintenance of the blind in nurses using a home-made questionnaire

Description

At the end of paclitaxel infusion of treatment 1 and 2

Time Frame

Day 1

Title

Side effects experienced by participants using a home-made questionnaire

Description

Focus on drowsiness, dry mouth, eyes or nose, dizziness and restlessness/excitement. For treatment 1 and treatment 2.

Time Frame

Day 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthieu Picard, M.D.

Organizational Affiliation

Ciusss de L'Est de l'Île de Montréal

Official's Role

Principal Investigator

Facility Information:

Facility Name

CIUSSS de l'Est-de-l'île-de-Montréal

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

1972736

Citation

Weiss RB, Donehower RC, Wiernik PH, Ohnuma T, Gralla RJ, Trump DL, Baker JR Jr, Van Echo DA, Von Hoff DD, Leyland-Jones B. Hypersensitivity reactions from taxol. J Clin Oncol. 1990 Jul;8(7):1263-8. doi: 10.1200/JCO.1990.8.7.1263.

Results Reference

background

PubMed Identifier

24740483

Citation

Picard M, Castells MC. Re-visiting Hypersensitivity Reactions to Taxanes: A Comprehensive Review. Clin Rev Allergy Immunol. 2015 Oct;49(2):177-91. doi: 10.1007/s12016-014-8416-0.

Results Reference

background

PubMed Identifier

28965634

Citation

Picard M. Management of Hypersensitivity Reactions to Taxanes. Immunol Allergy Clin North Am. 2017 Nov;37(4):679-693. doi: 10.1016/j.iac.2017.07.004. Epub 2017 Aug 18.

Results Reference

background

PubMed Identifier

30419768

Citation

Durham CG, Thotakura D, Sager L, Foster J, Herrington JD. Cetirizine versus diphenhydramine in the prevention of chemotherapy-related hypersensitivity reactions. J Oncol Pharm Pract. 2019 Sep;25(6):1396-1401. doi: 10.1177/1078155218811505. Epub 2018 Nov 12.

Results Reference

background

Citation

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.

Results Reference

background

PubMed Identifier

17357372

Citation

del Cuvillo A, Mullol J, Bartra J, Davila I, Jauregui I, Montoro J, Sastre J, Valero AL. Comparative pharmacology of the H1 antihistamines. J Investig Allergol Clin Immunol. 2006;16 Suppl 1:3-12. No abstract available.

Results Reference

background

PubMed Identifier

17883909

Citation

Banerji A, Long AA, Camargo CA Jr. Diphenhydramine versus nonsedating antihistamines for acute allergic reactions: a literature review. Allergy Asthma Proc. 2007 Jul-Aug;28(4):418-26. doi: 10.2500/aap.2007.28.3015.

Results Reference

background

PubMed Identifier

25519756

Citation

Berger MJ, Vargo C, Vincent M, Shaver K, Phillips G, Layman R, Macrae E, Mrozek E, Ramaswamy B, Wesolowski R, Shapiro CL, Lustberg MB. Stopping paclitaxel premedication after two doses in patients not experiencing a previous infusion hypersensitivity reaction. Support Care Cancer. 2015 Jul;23(7):2019-24. doi: 10.1007/s00520-014-2556-x. Epub 2014 Dec 18.

Results Reference

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PubMed Identifier

34997314

Citation

Beaucage-Charron J, Gaudet L, Lamothe S, Pelletier C, Pepin AS, Roy V, Charpentier F, Lordkipanidze M, Projean D, Bouchard P, Picard M. A randomized double-blind feasibility study comparing cetirizine and diphenhydramine in the prevention of paclitaxel-associated infusion-related reactions: the PREMED-F1 study. Support Care Cancer. 2022 Apr;30(4):3389-3399. doi: 10.1007/s00520-021-06734-4. Epub 2022 Jan 8.

Results Reference

derived

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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

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