Prevention of Hypersensitivity Reactions to Paclitaxel Clinical Trial
— DEXEL-RHOfficial 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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | August 2013 |
| Est. primary completion date | August 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Canada | Oncology oupatient clinic and oncology unit; CHUM Notre-Dame Hospital | Montreal | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | Use of rescue medication | Proportion of participants that needed rescue medication | During the administration of paclitaxel (Day 1) of the first cycle of chemotherapy | No |
| Secondary | Use of rescue medication | Proportion of participants that needed rescue medication | During the administration of paclitaxel (Day 1) of the second cycle of chemotherapy | No |
| Secondary | 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 | Yes |
| Secondary | 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 | Yes |