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

NCT04237090 | Completed Phase 3 FDA Drug

• 1 other identifier: 2020-2110
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Change from baseline of drowsiness on Stanford Sleepiness Scale 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

  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

  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.

  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.

  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 Outcomes (2)

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

  Day 1

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

  Day 1

Other Outcomes (5)

• Proportion of participants who completed the study

  Through the course of the study, 8 months

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

  Day 1

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

  Day 1

Study Arms (2)

Diphenhydramine + placebo

ACTIVE COMPARATOR

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: Lactose pill

Cetirizine + placebo

EXPERIMENTAL

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: Sodium chloride 0.9%

Interventions

Diphenhydramine DRUG

Drug identification number : 02369567

Also known as: Benadryl

Diphenhydramine + placebo

Cetirizine DRUG

Drug identification number : 02231603

Also known as: Reactine

Cetirizine + placebo

Lactose pill DRUG

Natural product number : 00501190

Diphenhydramine + placebo

Sodium chloride 0.9% DRUG

Drug identification number : 00037796

Cetirizine + placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

CIUSSS de l'Est-de-l'île-de-Montréal

Montreal, Quebec, H1T 2M4, Canada

Location

Related Publications (9)

• 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.

  PMID: 1972736 BACKGROUND

• 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.

  PMID: 24740483 BACKGROUND

• 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.

  PMID: 28965634 BACKGROUND

• 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.

  PMID: 30419768 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 17357372 BACKGROUND

• 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.

  PMID: 17883909 BACKGROUND

• 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.

  PMID: 25519756 BACKGROUND

• 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.

  PMID: 34997314 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Ovarian Neoplasms; Esophageal Neoplasms; Head and Neck Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms

Interventions

Diphenhydramine; Cetirizine; Lactose; Sodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases

Intervention Hierarchy (Ancestors)

Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Matthieu Picard, M.D.

  Ciusss de L'Est de l'Île de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant clinical professor

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 22, 2020
• Study Start: February 14, 2020
• Primary Completion: August 28, 2020
• Study Completion: September 4, 2020
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)