Prevention of Hypersensitivity Reactions to PaclitaxelDEXEL-RHNCT01797991
Comparison of Two Regimens of Dexamethasone in the Prevention of Hypersensitivity Reactions to Paclitaxel, a Pilot Study
A study testing Dexamethasone per os and Dexamethasone IV in people with Prevention of Hypersensitivity Reactions to Paclitaxel, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prevention of Hypersensitivity Reactions to Paclitaxel
- What is being tested?
- Dexamethasone per os and Dexamethasone IV
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site
Oncology oupatient clinic and oncology unit; CHUM Notre-Dame Hospital
Montreal, Quebec
About this study
Official title: 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.
Read the 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.
- Being tested
- Dexamethasone per os, Matching placebo for dexamethasone IV, Dexamethasone IV, Matching placebo for dexamethasone per os
- Keywords
- Hypersensitivity, drug
- Medical subject headings
- Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone per osDrug
Matching placebo for dexamethasone IVDrug
Dexamethasone IVDrug
Matching placebo for dexamethasone per osDrug
| Study group | Role | What they receive |
|---|---|---|
| Group A (dexamethasone per os) | Active comparator | * 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 Receives: Drug: Dexamethasone per os; Drug: Matching placebo for dexamethasone IV |
| Group B (dexamethasone IV) | Experimental | * 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) Receives: Drug: Dexamethasone IV; Drug: Matching placebo for dexamethasone per os |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 6 of the second cycle of chemotherapy
Secondary outcomes (6)
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.
Measured: 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.
Measured: During the administration of paclitaxel (Day 1) of the second cycle of chemotherapy
Use of rescue medication
Proportion of participants that needed rescue medication
Measured: During the administration of paclitaxel (Day 1) of the first cycle of chemotherapy
Use of rescue medication
Proportion of participants that needed rescue medication
Measured: 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
Measured: 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
Measured: Assessed on a daily basis from Day 1 to Day 7 of the second cycle of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Hypersensitivity Reactions to PaclitaxelStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa Samouelian, M.D., Ph. D., Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797991
- Sponsor's protocol ID
- CE12.270
- Acronym
- DEXEL-RH
- Status last verified
- Oct 2013
- First submitted
- 19 Feb 2013
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Étude Pilote DEXEL-RH: Comparaison de Deux schémas Posologiques de DEXaméthasone en prévention Des Réactions d'Hypersensibilité au paclitaXEL
- ClinicalTrials.gov ID
- NCT01797991
- Acronym / sponsor ID
- DEXEL-RH / CE12.270
- Keywords
- Hypersensitivity, drug
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Feb 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 25 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (dexamethasone per os) | Active comparator | Drug: Dexamethasone per os, Drug: Matching placebo for dexamethasone IV* 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 B (dexamethasone IV) | Experimental | Drug: Dexamethasone IV, Drug: Matching placebo for dexamethasone per os* 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone per os | Drug | Group A (dexamethasone per os) |
| Matching placebo for dexamethasone IV | Drug | Group A (dexamethasone per os) |
| Dexamethasone IV | Drug | Group B (dexamethasone IV) |
| Matching placebo for dexamethasone per os | Drug | Group B (dexamethasone IV) |
Primary outcome
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)
Time frame: Day before chemotherapy (Day 0) of the first cycle of chemotherapy
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
Time frame: Day 6 of the first cycle of chemotherapy
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
Time frame: Day before chemotherapy (Day 0) of the second cycle of chemotherapy
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
Time frame: Day 6 of the second cycle of chemotherapy
Comparison of the scores according to the EORTC Scoring Manual.
6 secondary outcomes
Acute hypersensitivity reactions assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03
Time frame: During the administration of paclitaxel (Day 1) of the first cycle of chemotherapy
Acute hypersensitivity reactions assessed by the NCI CTCAE version 4.03
Time frame: During the administration of paclitaxel (Day 1) of the second cycle of chemotherapy
Use of rescue medication
Time frame: During the administration of paclitaxel (Day 1) of the first cycle of chemotherapy
Use of rescue medication
Time frame: During the administration of paclitaxel (Day 1) of the second cycle of chemotherapy
Adverse effects self-assessed by a personal logbook
Time frame: 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
Time frame: Assessed on a daily basis from Day 1 to Day 7 of the second cycle of chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Samouelian, M.D., Ph. D. principal investigator
CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone per os and Dexamethasone IV in people with Prevention of Hypersensitivity Reactions to Paclitaxel, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Day before chemotherapy (Day 0) of the first cycle of chemotherapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2013.