NCT02815319

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 cancer

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

1.8 years

First QC Date

May 2, 2016

Last Update Submit

April 26, 2020

Conditions

Cancer

Keywords

DexamethasoneChemotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Hypersensitivity rate

    2 years

  • Fluid retention

    2 years

  • Hospital cost

    2 years

  • Skin toxicity

    2 years

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Physician's treatment recommendation for dexamethasone premedication

Drug: Dexamethasone

8mg PO dexamethasone

ACTIVE COMPARATOR

8mg PO dexamethasone premedication

Drug: Dexamethasone

Interventions

DexamethasoneDRUG

Steroid prophylaxis

Also known as: Decadron
8mg PO dexamethasoneStandard of care

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving docetaxel chemotherapy for cancer
  • Have incorrectly taken some or all of their dexamethasone premedication
  • ≥19 years of age

You may not qualify if:

  • Contraindication to dexamethasone
  • Unable to give informed consent
  • Already included in the study during a prior cycle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K2C2R8, Canada

Location

Related Publications (1)

  • 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.

    PMID: 33057999DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

DexamethasoneCalcium Dobesilate

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Tina Hsu, MD

    The Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2016

First Posted

June 28, 2016

Study Start

January 1, 2017

Primary Completion

October 30, 2018

Study Completion

March 15, 2019

Last Updated

April 28, 2020

Record last verified: 2020-04

Locations

CA(1)