Back to resultsComparison of Two Regimens of Dexamethasone in the Prevention of Hypersensitivity Reactions to Paclitaxel, a Pilot Study (DEXEL-RH)
Primary Purpose
Prevention of Hypersensitivity Reactions to Paclitaxel
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dexamethasone per os
Matching placebo for dexamethasone IV
Dexamethasone IV
Matching placebo for dexamethasone per os
Sponsored by
About this trial
This is an interventional prevention trial for Prevention of Hypersensitivity Reactions to Paclitaxel focused on measuring Hypersensitivity, 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).
Sites / Locations
- Oncology oupatient clinic and oncology unit; CHUM Notre-Dame Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group A (dexamethasone per os)
Group B (dexamethasone IV)
Arm 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
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)
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
Use of rescue medication
Proportion of participants that needed rescue medication
Use of rescue medication
Proportion of participants that needed rescue medication
Adverse effects self-assessed by a personal logbook
Proportion of participants with adverse effects
Adverse effects self-assessed by a personal logbook
Proportion of participants with adverse effects
Full Information
NCT ID
NCT01797991
First Posted
February 19, 2013
Last Updated
October 29, 2013
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
1. Study Identification
Unique Protocol Identification Number
NCT01797991
Brief Title
Comparison of Two Regimens of Dexamethasone in the Prevention of Hypersensitivity Reactions to Paclitaxel, a Pilot Study
Acronym
DEXEL-RH
Official Title
Étude Pilote DEXEL-RH: Comparaison de Deux schémas Posologiques de DEXaméthasone en prévention Des Réactions d'Hypersensibilité au paclitaXEL
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Hypersensitivity Reactions to Paclitaxel
Keywords
Hypersensitivity, drug
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A (dexamethasone per os)
Arm Type
Active Comparator
Arm 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
Arm Title
Group B (dexamethasone IV)
Arm Type
Experimental
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone per os
Intervention Type
Drug
Intervention Name(s)
Matching placebo for dexamethasone IV
Intervention Type
Drug
Intervention Name(s)
Dexamethasone IV
Intervention Type
Drug
Intervention Name(s)
Matching placebo for dexamethasone per os
Primary Outcome Measure Information:
Title
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)
Description
Comparison of the scores according to the EORTC Scoring Manual.
Time Frame
Day before chemotherapy (Day 0) of the first cycle of chemotherapy
Title
Quality of life assessed by the self-administered questionnaire QLQ-C30 version 3.0 from the EORTC
Description
Comparison of the scores according to the EORTC Scoring Manual.
Time Frame
Day 6 of the first cycle of chemotherapy
Title
Quality of life assessed by the self-administered questionnaire QLQ-C30 version 3.0 from the EORTC
Description
Comparison of the scores according to the EORTC Scoring Manual.
Time Frame
Day before chemotherapy (Day 0) of the second cycle of chemotherapy
Title
Quality of life assessed by the self-administered questionnaire QLQ-C30 version 3.0 from the EORTC
Description
Comparison of the scores according to the EORTC Scoring Manual.
Time Frame
Day 6 of the second cycle of chemotherapy
Secondary Outcome Measure Information:
Title
Acute hypersensitivity reactions assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03
Description
Proportion of participants that had acute hypersensitivity reactions. Adverse events selected: allergic reaction, anaphylaxis, dyspnea, chest pain, hypertension, back pain and abdominal pain.
Time Frame
During the administration of paclitaxel (Day 1) of the first cycle of chemotherapy
Title
Acute hypersensitivity reactions assessed by the NCI CTCAE version 4.03
Description
Proportion of participants that had acute hypersensitivity reactions. Adverse events selected: allergic reaction, anaphylaxis, dyspnea, chest pain, hypertension, back pain and abdominal pain.
Time Frame
During the administration of paclitaxel (Day 1) of the second cycle of chemotherapy
Title
Use of rescue medication
Description
Proportion of participants that needed rescue medication
Time Frame
During the administration of paclitaxel (Day 1) of the first cycle of chemotherapy
Title
Use of rescue medication
Description
Proportion of participants that needed rescue medication
Time Frame
During the administration of paclitaxel (Day 1) of the second cycle of chemotherapy
Title
Adverse effects self-assessed by a personal logbook
Description
Proportion of participants with adverse effects
Time Frame
Assessed on a daily basis from Day 1 to Day 7 of the first cycle of chemotherapy
Title
Adverse effects self-assessed by a personal logbook
Description
Proportion of participants with adverse effects
Time Frame
Assessed on a daily basis from Day 1 to Day 7 of the second cycle of chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Samouelian, M.D., Ph. D.
Organizational Affiliation
CHUM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oncology oupatient clinic and oncology unit; CHUM Notre-Dame Hospital
City
Montreal
State/Province
Quebec
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Comparison of Two Regimens of Dexamethasone in the Prevention of Hypersensitivity Reactions to Paclitaxel, a Pilot Study
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