Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Breast Neoplasms

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Head and Neck Neoplasms

Endometrial Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Neoplasms

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Allergic Agents

Antiemetics

Central Nervous System Depressants

Gastrointestinal Agents

Dermatologic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Diphenhydramine

Promethazine

Famotidine

Cetirizine

Hypnotics and Sedatives

Anesthetics

Anesthetics, Local

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

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

Immune System Diseases

Hypersensitivity

Anti-Inflammatory Agents

Dexamethasone

Dexamethasone acetate

Clemastine

Subjects receiving standard of care treatment with paclitaxel either as monotherapy or as part of a combination for any standard of care oncologic indication. Subjects received a paclitaxel premedication regimen containing dexamethasone 10 mg IV and clemastine 2 mg IV

Subjects receiving standard of care treatment with paclitaxel either as monotherapy or as part of a combination for any standard of care oncologic indication. Subjects received a paclitaxel premedication regimen containing dexamethasone 10 mg IV and cetirizine 10 mg PO

Subjects were treated with a paclitaxel premedication regimen which contained oral cetirizine instead of intravenous clemastine

Roelof van Leeuwen, PharmD, PhD

In this study the effect of substituting clemastine IV to cetirizine PO on the occurence of hypersensitivity reactions during paclitaxel chemotherapy will be investigated.

This is a single arm before-after study with a historic control cohort to evaluate the effect of a policy change (i.e. substitution of clemastine IV for cetirizine PO) regarding the premedication scheme on the incidence of HSR during paclitaxel based chemotherapy.

The Effect of Switching the H1-antagonist Clemastine to Cetirizine in Premedication Regimens During Paclitaxel Treatment

The Effect of Switching the H1-antagonist Clemastine to Cetirizine in Premedication Regimens During Paclitaxel Treatment: 'The H1-SWITCH Study'

Hypersensitivity reactions grade 3 or higher according to CTCAE v4.03

Hypersensitivity reactions any grade according to CTCAE v4.03

The difference in the number of paclitaxel dosages until first the occurrence of hypersensitivity reactions between the arms will be described.

The cumulative dose of paclitaxel (mg/m2) administered prior to the moment of occurrence of hypersensitivity reaction

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
The Effect of Switching the H1-antagonist Clemastine to Cetirizine in Premedication Regimens During Paclitaxel Treatment	NCT06039137	Solid Tumor	Cetirizine	18 Years -	Erasmus Medical Center
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 cetirizine

Every month we try and update this database with for cetirizine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cetirizine

Every month we try and update this database with for cetirizine cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cetirizine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.