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

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

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.

Study Overview

• Status: Completed
• Conditions: Prevention of Hypersensitivity Reactions to Paclitaxel
• Intervention / Treatment: Drug: Dexamethasone per os; Drug: Matching placebo for dexamethasone IV; Drug: Dexamethasone IV; Drug: Matching placebo for dexamethasone per os

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada
      • Oncology oupatient clinic and oncology unit; CHUM Notre-Dame Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Dexamethasone per os; Drug: Matching placebo for dexamethasone IV
Experimental: 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)	Drug: Dexamethasone IV; Drug: Matching placebo for dexamethasone per os

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Comparison of the scores according to the EORTC Scoring Manual.	Day before chemotherapy (Day 0) of the first cycle of chemotherapy
Quality of life assessed by the self-administered questionnaire QLQ-C30 version 3.0 from the EORTC	Comparison of the scores according to the EORTC Scoring Manual.	Day 6 of the first cycle of chemotherapy
Quality of life assessed by the self-administered questionnaire QLQ-C30 version 3.0 from the EORTC	Comparison of the scores according to the EORTC Scoring Manual.	Day before chemotherapy (Day 0) of the second cycle of chemotherapy
Quality of life assessed by the self-administered questionnaire QLQ-C30 version 3.0 from the EORTC	Comparison of the scores according to the EORTC Scoring Manual.	Day 6 of the second cycle of chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute hypersensitivity reactions assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03	Proportion of participants that had acute hypersensitivity reactions. Adverse events selected: allergic reaction, anaphylaxis, dyspnea, chest pain, hypertension, back pain and abdominal pain.	During the administration of paclitaxel (Day 1) of the first cycle of chemotherapy
Acute hypersensitivity reactions assessed by the NCI CTCAE version 4.03	Proportion of participants that had acute hypersensitivity reactions. Adverse events selected: allergic reaction, anaphylaxis, dyspnea, chest pain, hypertension, back pain and abdominal pain.	During the administration of paclitaxel (Day 1) of the second cycle of chemotherapy
Use of rescue medication	Proportion of participants that needed rescue medication	During the administration of paclitaxel (Day 1) of the first cycle of chemotherapy
Use of rescue medication	Proportion of participants that needed rescue medication	During the administration of paclitaxel (Day 1) of the second cycle of chemotherapy
Adverse effects self-assessed by a personal logbook	Proportion of participants with adverse effects	Assessed on a daily basis from Day 1 to Day 7 of the first cycle of chemotherapy
Adverse effects self-assessed by a personal logbook	Proportion of participants with adverse effects	Assessed on a daily basis from Day 1 to Day 7 of the second cycle of chemotherapy

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Vanessa Samouelian, M.D., Ph. D., CHUM

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: February 19, 2013
• First Submitted That Met QC Criteria: February 21, 2013
• First Posted (Estimate): February 25, 2013

Study Record Updates

• Last Update Posted (Estimate): October 31, 2013
• Last Update Submitted That Met QC Criteria: October 29, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Hypersensitivity, drug
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: CE12.270

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No