Clinical trial · Interventional
Feasibility of a Clinical Trial Comparing the Use of Cetirizine to Replace Diphenhydramine in the Prevention of Reactions Related to Paclitaxel
Feasibility of a Randomized Controlled Clinical Trial Comparing the Use of Cetirizine to Replace Diphenhydramine in the Prevention of Reactions Related to Paclitaxel
NCT04237090CI-TRIAL-00047617PREMED-F1completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Head Cancer Neck | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Oesophageal Cancer | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetirizine | Drug | — | UNRESOLVED |
| Diphenhydramine | Drug | — | UNRESOLVED |
| Lactose pill | Drug | — | UNRESOLVED |
| Sodium chloride 0.9% | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Diphenhydramine + placebo
- 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.
- interventionNames
- Drug: Diphenhydramine
- Drug: Lactose pill
- type
- EXPERIMENTAL
- label
- Cetirizine + placebo
- description
- 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.
- interventionNames
- Drug: Cetirizine
- Drug: Sodium chloride 0.9%
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (9)
- BACKGROUNDWeiss 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
- BACKGROUNDPicard 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
- BACKGROUNDPicard 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
- BACKGROUNDDurham 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
- BACKGROUNDSiderov 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.
- BACKGROUNDdel 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
- BACKGROUNDBanerji 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
- BACKGROUNDBerger 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.