Skip to main content
OpenTrials
Completed

NCT Number: NCT02815319

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K2C2R8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Steroid prophylaxis

Other names: Decadron

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study 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)

Acronym: REaCT-dex

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 28, 2016
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.