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

NCT ID: NCT02815319

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-03-15

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of care

Physician's treatment recommendation for dexamethasone premedication

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Steroid prophylaxis

8mg PO dexamethasone

8mg PO dexamethasone premedication

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Steroid prophylaxis

Interventions

Dexamethasone

Steroid prophylaxis

Intervention Type: DRUG

Other Intervention Names

Decadron

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tina Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital Research Institute

Locations

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 33057999 (View on PubMed)

Other Identifiers

OTT 16-02

Identifier Type: -

Identifier Source: org_study_id