Schedules of Dexamethasone in Patients Incorrectly Taking Dexamethasone Premedication (REaCT-dexamethasone)
- Registration Number
- NCT02815319
- Lead Sponsor
- Ottawa Hospital Research Institute
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Patients receiving docetaxel chemotherapy for cancer
- Have incorrectly taken some or all of their dexamethasone premedication
- ≥19 years of age
- Contraindication to dexamethasone
- Unable to give informed consent
- Already included in the study during a prior cycle
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of care Dexamethasone Physician's treatment recommendation for dexamethasone premedication 8mg PO dexamethasone Dexamethasone 8mg PO dexamethasone premedication
- Primary Outcome Measures
Name Time Method 8mg PO stat is associated with significant reduction in time to commence docetaxel chemotherapy 1 year 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.
- Secondary Outcome Measures
Name Time Method Hypersensitivity rate 2 years Rates of hypersensitivity reactions to docetaxel
Skin toxicity 2 years Number of participants with skin toxicities
Hospital cost 2 years 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.
Fluid retention 2 years Number of participants with fluid retention
Trial Locations
- Locations (1)
The Ottawa Hospital Cancer Centre
🇨🇦Ottawa, Ontario, Canada