Completed

DEXEL-RHÉtude Pilote DEXEL-RH: Comparaison de Deux schémas Posologiques de DEXaméthasone en prévention Des Réactions d'Hypersensibilité au paclitaXEL

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What is being tested

Dexamethasone per os

+ Matching placebo for dexamethasone IV

+ Dexamethasone IV

Drug
Who is being recruted

Chemically-Induced Disorders

+ Drug-Related Side Effects and Adverse Reactions

+ Drug Hypersensitivity

Over 18 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorCentre hospitalier de l'Université de Montréal (CHUM)
Last updated: October 31, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

Primary objective: To assess the feasibility of a randomized, parallel, two-arm, controlled and double blind trial designed to compare the quality of life of patients taking dexamethasone 20 mg IV 30 minutes before paclitaxel with those taking a standard dose of dexamethasone, 20 mg orally 12 hours and 6 hours before paclitaxel, in patients taking paclitaxel every two to three weeks for a minimum of two cycles in order to estimate a sample size. Secondary objectives: Between the two study groups, to compare: Quality of life during the first two cycles of chemotherapy; Efficacy of dexamethasone in preventing acute hypersensitivity reactions to paclitaxel in the first two cycles of chemotherapy; Adverse effects associated with dexamethasone on a daily basis during the first seven days of the first two cycles of chemotherapy. Eligible patients will be randomized in a 1:1 ratio to one of the two study groups.

NCT01797991
Principal SponsorCentre hospitalier de l'Université de Montréal (CHUM)
Last updated: October 31, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chemically-Induced DisordersDrug-Related Side Effects and Adverse ReactionsDrug Hypersensitivity

Criteria

6 inclusion criteria required to participate
Patient able to complete the questionnaire on quality of life EORTC QLQ-C30 and the personal logbook
Patient able to give free and informed consent and who agrees to participate by signing the consent form
Patient aged 18 years and over
Patient diagnosed with cancer
Show More Criteria
8 exclusion criteria prevent from participating
Patient in another research protocol evaluating a different chemotherapy regimen
Patient is currently under treatment with systemic corticosteroids or has received systemic corticosteroids during the last week
Patient receiving a prescription of paclitaxel bound to albumin
Patient unable to speak English or French
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Dexamethasone 20 mg per os 12 hours and 6 hours before paclitaxel (form: opaque white capsules) Matching placebo for dexamethasone IV (NaCl 0,9%) 30 minutes before paclitaxel

Group II

Experimental
Dexamethasone 20 mg IV 30 minutes before paclitaxel Matching placebo for dexamethasone per os (lactose capsule) 12 hours and 6 hours before paclitaxel (form: opaque white capsules)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Oncology oupatient clinic and oncology unit; CHUM Notre-Dame Hospital

Montreal, CanadaOpen Oncology oupatient clinic and oncology unit; CHUM Notre-Dame Hospital in Google Maps
CompletedOne Study Center