Schedules of Dexamethasone in Patients Incorrectly Taking Dexamethasone Premedication (REaCT-dexamethasone)

Study Overview
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Brief Summary
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Docetaxel chemotherapy is commonly used in patients with breast cancer. With the widespread use of steroid premedication, the incidence of fluid retention and skin toxicity side effects has been minimal. Premedication with dexamethasone (8mg twice daily) is recommended starting the day before chemotherapy and continuing for three days. Patients may forget to take all or part of their premedication prior to docetaxel administration, and additional doses of steroids are frequently give in place of the forgotten oral dose. The processes around treating patients who have incorrectly taken their medication are cumbersome leading to significant delays in patients receiving their chemotherapy while the chemotherapy nurse tries to contact the patients treating physician for guidance on the dose and route of dexamethasone they want administered. Most importantly with the current standard of care procedure, by the time the chemotherapy nurse, pharmacist and medical oncologist have spoken and made a treatment plan, the patient has been waiting for on average of an additional 1-2 hours before actually starting their chemotherapy.

Detailed Description
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This study will randomize cancer patients to a standard dose of dexamethasone 8mg orally or to contact the physician to see what dose they recommend. The current trial proposal could therefore reduce the time for which patients are waiting to receive their chemotherapy, improving time patients need to spend in the hospital and significantly improving practice not just in Ottawa but globally.

Official Title
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A Single Centre Randomised Study Comparing Standard of Care Schedules of Dexamethasone in Patients Incorrectly Taking Dexamethasone Premedication Prior to Docetaxel Chemotherapy (REaCT-dexamethasone)

Conditions
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Cancer

Intervention / Treatment
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* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving docetaxel chemotherapy for cancer Have incorrectly taken some or all of their dexamethasone premedication ≥19 years of age Exclusion Criteria: Contraindication to dexamethasone Unable to give informed consent Already included in the study during a prior cycle

Ages Eligible for Study
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Minimum Age: 19 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care<br>Physician's treatment recommendation for dexamethasone premedication | Drug: Dexamethasone<br>* Steroid prophylaxis<br>* Other names: Decadron;|
| Active Comparator: 8mg PO dexamethasone<br>8mg PO dexamethasone premedication | Drug: Dexamethasone<br>* Steroid prophylaxis<br>* Other names: Decadron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 8mg PO stat is associated with significant reduction in time to commence docetaxel chemotherapy | To demonstrate that use of a standard replacement dose of dexamethasone (8mg PO stat) is associated with a significant reduction in the time for patients to commence their docetaxel chemotherapy. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypersensitivity rate | Rates of hypersensitivity reactions to docetaxel | 2 years | 
| Fluid retention | Number of participants with fluid retention | 2 years | 
| Hospital cost | The hospital cost for each patient encounter will be estimated using a standardized case-costing methodology that was developed by the Ontario Case Costing Initiatives. This case-costing method is based on the Canadian Institute for Health Information Management Information Systems guidelines. The case-costing system links financial, clinical and patient activity information stored within information systems of the data warehouse to define intermediate products (e.g., nursing time, medications, laboratory tests). Direct and indirect hospital costs for each intermediate product used during an encounter are then summed for each patient. | 2 years | 
| Skin toxicity | Number of participants with skin toxicities | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexamethasone, Chemotherapy