Comparison of Two Regimens of Dexamethasone in the Prevention of Hypersensitivity Reactions to Paclitaxel, a Pilot Study

NCT ID: NCT01797991

Last Updated: 2013-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-08-31

Brief Summary

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.

Detailed 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.

Conditions

Prevention of Hypersensitivity Reactions to Paclitaxel

Keywords

Hypersensitivity, drug

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group A (dexamethasone per os)

• 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 Type: ACTIVE_COMPARATOR

Dexamethasone per os

Intervention Type: DRUG

Matching placebo for dexamethasone IV

Intervention Type: DRUG

Group B (dexamethasone IV)

• 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)

Group Type: EXPERIMENTAL

Dexamethasone IV

Intervention Type: DRUG

Matching placebo for dexamethasone per os

Intervention Type: DRUG

Interventions

Dexamethasone per os

Intervention Type: DRUG

Matching placebo for dexamethasone IV

Intervention Type: DRUG

Dexamethasone IV

Intervention Type: DRUG

Matching placebo for dexamethasone per os

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

CHUM

Locations

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

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

CE12.270

Identifier Type: -

Identifier Source: org_study_id