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Genital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Central Nervous System Depressants

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Paclitaxel

Albumin-Bound Paclitaxel

Diphenhydramine

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Histamine

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Histamine H1 Antagonists, Non-Sedating

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.

Lactose pill

Sodium chloride 0.9%

Matthieu Picard, M.D.

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.

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.

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

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

At the end of paclitaxel infusion of treatment 2

At the end of paclitaxel infusion of treatment 1 and 2

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

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

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

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

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

Ciusss de L'Est de l'Île de Montréal

Assitant clinical professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Feasibility of a Clinical Trial Comparing the Use of Cetirizine to Replace Diphenhydramine in the Prevention of Reactions Related to Paclitaxel	NCT04237090	Breast Cancer Lung Cancer Ovarian Cancer Oesophageal Can... Head Cancer Nec... Cervical Cancer Endometrial Can...	Diphenhydramine Cetirizine Lactose pill Sodium chloride...	18 Years -	Ciusss de L'Est de l'Île de Montréal
Feasibility of a Clinical Trial Comparing the Use of Cetirizine to Replace Diphenhydramine in the Prevention of Reactions Related to Paclitaxel	NCT04237090	Breast Cancer Lung Cancer Ovarian Cancer Oesophageal Can... Head Cancer Nec... Cervical Cancer Endometrial Can...	Diphenhydramine Cetirizine Lactose pill Sodium chloride...	18 Years -	Ciusss de L'Est de l'Île de Montréal

Spots Global Cancer Trial Database for lactose pill

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