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


N/A
18 Years
N/A
Open (Enrolling)
Both
Prevention of Hypersensitivity Reactions to Paclitaxel

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Trial Information

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


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.


Inclusion Criteria:



- Patient treated at the outpatient clinic or admitted to the oncology unit of
Notre-Dame Hospital between February 4, 2013 and July 19, 2013;

- Patient diagnosed with cancer;

- Patient starting a chemotherapy containing paclitaxel every two to three weeks for a
minimum of two cycles;

- Patient aged 18 years and over;

- Patient able to give free and informed consent and who agrees to participate by
signing the consent form;

- Patient able to complete the questionnaire on quality of life EORTC QLQ-C30 and the
personal logbook.

Exclusion Criteria:

- Patient unable to speak English or French;

- Patient who has previously received paclitaxel;

- Patient receiving a prescription of paclitaxel bound to albumin;

- Patient is currently under treatment with systemic corticosteroids or has received
systemic corticosteroids during the last week;

- Patient in another research protocol evaluating a different chemotherapy regimen;

- Patient who had an allergic reaction to taxanes;

- Patient with severe intolerance to lactose;

- Patient with an allergy or a severe intolerance to products containing castor oil
(eg.: cyclosporine and vitamin K).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Quality of life assessed by the self-administered quality of life core questionnaire (QLQ-C30) version 3.0 from the European Organisation for Research and Treatment in Cancer (EORTC)

Outcome Description:

Comparison of the scores according to the EORTC Scoring Manual.

Outcome Time Frame:

Day before chemotherapy (Day 0) of the first cycle of chemotherapy

Safety Issue:

No

Principal Investigator

Vanessa Samouelian, M.D., Ph. D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHUM

Authority:

Canada: Health Canada

Study ID:

CE12.270

NCT ID:

NCT01797991

Start Date:

February 2013

Completion Date:

Related Keywords:

  • Prevention of Hypersensitivity Reactions to Paclitaxel
  • Hypersensitivity, drug
  • Hypersensitivity

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