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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.
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:
Eligible patients will be randomized in a 1:1 ratio to one of the two study groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (dexamethasone per os) | Active Comparator |
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| Group B (dexamethasone IV) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone per os | Drug |
| ||
| Matching placebo for dexamethasone IV |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa Samouelian, M.D., Ph. D. | CHUM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology oupatient clinic and oncology unit; CHUM Notre-Dame Hospital | Montreal | Quebec | Canada |
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| Drug |
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| Dexamethasone IV | Drug |
|
| Matching placebo for dexamethasone per os | Drug |
|
| 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 |
| ID | Term |
|---|---|
| D004342 | Drug Hypersensitivity |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
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