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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prevention of Hypersensitivity Reactions to Paclitaxel

Intervention / Treatment
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* Drug: Dexamethasone per os
* Drug: Matching placebo for dexamethasone IV
* Drug: Dexamethasone IV
* Drug: Matching placebo for dexamethasone per os


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (dexamethasone per os)<br>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<br> <br> Drug: Matching placebo for dexamethasone IV<br> <br> |
| Experimental: Group B (dexamethasone IV)<br>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<br> <br> Drug: Matching placebo for dexamethasone per os<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypersensitivity, drug