Feasibility of a Clinical Trial Comparing the Use of Cetirizine to Replace Diphenhydramine in the Prevention of Reactions Related to Paclitaxel
NCT ID: NCT04237090
Last Updated: 2020-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
27 participants
INTERVENTIONAL
2020-02-14
2020-09-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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.
Diphenhydramine
Drug identification number : 02369567
Lactose pill
Natural product number : 00501190
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.
Cetirizine
Drug identification number : 02231603
Sodium chloride 0.9%
Drug identification number : 00037796
Interventions
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Diphenhydramine
Drug identification number : 02369567
Cetirizine
Drug identification number : 02231603
Lactose pill
Natural product number : 00501190
Sodium chloride 0.9%
Drug identification number : 00037796
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ciusss de L'Est de l'Île de Montréal
OTHER
Responsible Party
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Matthieu Picard
Assitant clinical professor
Principal Investigators
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Matthieu Picard, M.D.
Role: PRINCIPAL_INVESTIGATOR
Ciusss de L'Est de l'Île de Montréal
Locations
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CIUSSS de l'Est-de-l'île-de-Montréal
Montreal, Quebec, Canada
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2020-2110
Identifier Type: -
Identifier Source: org_study_id
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