Comparison of Two Regimens of Dexamethasone in the Prevention of Hypersensitivity Reactions to Paclitaxel, a Pilot Study (DEXEL-RH)

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Completed

Conditions: Prevention of Hypersensitivity Reactions to Paclitaxel

Treatments: Drug: Dexamethasone per os; Drug: Dexamethasone IV; Drug: Matching placebo for dexamethasone IV; Drug: Matching placebo for dexamethasone per os

Study type: Interventional

Funder types: Other

Identifiers

NCT01797991

CE12.270

Details and patient eligibility

About

This is a prospective, randomized, unicentric, two-arm, parallel, controlled, and double blind pilot study.

The purpose of this pilot study is to assess the feasibility of a trial designed to compare the quality of life of patients taking dexamethasone in two different ways to prevent hypersensitivity reactions to paclitaxel.

Dexamethasone given intravenously (IV) 30 minutes before paclitaxel could improve quality of life, could adequately prevent hypersensitivity reactions to paclitaxel and could reduce adverse effects compared to dexamethasone given orally 12 hours and 6 hours before paclitaxel.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Group A (dexamethasone per os)

Active Comparator group

Description:

* 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

Treatment:

Drug: Matching placebo for dexamethasone IV

Drug: Dexamethasone per os

Group B (dexamethasone IV)

Experimental group

Description:

* 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)

Treatment:

Drug: Dexamethasone IV

Drug: Matching placebo for dexamethasone per os