Clinical trial NCT02815319: Schedules of Dexamethasone in Patients Incorrectly Taking Dexamethasone Premedication (REaCT-dexamethasone)
Official title: A Single Centre Randomised Study Comparing Standard of Care Schedules of Dexamethasone in Patients Incorrectly Taking Dexamethasone Premedication Prior to Docetaxel Chemotherapy (REaCT-dexamethasone)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer
Keywords: Dexamethasone
Chemotherapy
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 8mg PO stat is associated with significant reduction in time to commence docetaxel chemotherapy
timeFrame: 1 year
Secondary outcomes:
measure: Hypersensitivity rate
timeFrame: 2 years
measure: Fluid retention
timeFrame: 2 years
measure: Hospital cost
timeFrame: 2 years
measure: Skin toxicity
timeFrame: 2 years
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
Study officials:
affiliation: The Ottawa Hospital Research Institute
name: Tina Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu T, Fergusson D, Stober C, Daigle K, Moledina N, Vandermeer L, Pond G, Hilton J, Hutton B, Clemons M; REaCT investigators. A randomized clinical trial comparing physician-directed or fixed-dose steroid replacement strategies for incomplete dexamethasone dosing prior to docetaxel chemotherapy. Support Care Cancer. 2021 Jun;29(6):3113-3120. doi: 10.1007/s00520-020-05791-5. Epub 2020 Oct 15.