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

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ClinicalTrials.gov Identifier: NCT02815319
Recruitment Status : Completed
First Posted : June 28, 2016
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cancer Drug: Dexamethasone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 2017
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard of care
Physician's treatment recommendation for dexamethasone premedication
Drug: Dexamethasone
Steroid prophylaxis
Other Name: Decadron

Active Comparator: 8mg PO dexamethasone
8mg PO dexamethasone premedication
Drug: Dexamethasone
Steroid prophylaxis
Other Name: Decadron




Primary Outcome Measures :
  1. 8mg PO stat is associated with significant reduction in time to commence docetaxel chemotherapy [ Time Frame: 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 :
  1. Hypersensitivity rate [ Time Frame: 2 years ]
    Rates of hypersensitivity reactions to docetaxel

  2. Fluid retention [ Time Frame: 2 years ]
    Number of participants with fluid retention

  3. Hospital cost [ Time Frame: 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.

  4. Skin toxicity [ Time Frame: 2 years ]
    Number of participants with skin toxicities



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815319


Locations
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Canada, Ontario
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K2C2R8
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Tina Hsu, MD The Ottawa Hospital Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02815319    
Other Study ID Numbers: OTT 16-02
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ottawa Hospital Research Institute:
Dexamethasone
Chemotherapy
Additional relevant MeSH terms:
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Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents