High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase After Mastectomy

NCT03125941 | Completed Phase 4 Results DMC

• 2 other identifiers: DEXMAS012017-000227-27
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effect of a single preoperative high-dose steroid injection on complications in the immediate postoperative phase after breast cancer surgery, with removal of the breast (mastectomy). Primary outcome is the proportion patients who require transfer to the post anaesthesia care unit (PACU) and the proportion that can be transferred directly to the ward. Secondary outcomes are organospecific complications in the postanesthesia phase, pain and nausea the first 5 days, seroma and wound infection the first 14 days and readmissions the first 30 days after surgery. The investigators hypothesize that the frequency of transfer to the PACU and organospecific complications will be lower among patients receiving high dose dexamethasone. The investigators hypothesize, that there will be no difference in wound infections, seroma or readmissions.

Conditions

Dexamethasone; Glucocorticoids; Mastectomy; Breast Cancer; Pain, Postoperative; Nausea and Vomiting, Postoperative; Steroid; Systemic Inflammatory Response Syndrome; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Transfer to Post-anesthesia Care Unit (PACU)

  Number of patients meeting criteria for transfer to PACU post-surgery

  Within 1 hour post-surgery

Secondary Outcomes (13)

• Discharge Score,(Modified Aldrete Discharge Score), Operating Room

  At transfer from operating room, within 1 hour post-surgery

• Discharge Score, Arrival at PACU

  within 3 hours

• Discharge Score, Arrival at Ward

  within 3 hours

• Number of Participants With Complication

  24 hours

• Total Length of Stay in PACU

  12 hours

Study Arms (2)

Dexamethasone 8 mg

ACTIVE COMPARATOR

Dexamethasone 8 mg pre-operative

Drug: Dexamethasone

Dexamethasone 24 mg

ACTIVE COMPARATOR

Dexamethasone 24 mg pre-operative

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

pre-operative intravenous administration

Dexamethasone 24 mg; Dexamethasone 8 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• planned unilateral mastectomy with or without axillary dissection or sentinel node in the study period
• informed signed consent

You may not qualify if:

• Chronic/ongoing use of glucocorticoids (except inhalation therapy)
• ongoing use of immunosuppressive therapy
• insulin dependent diabetes
• pregnancy/breastfeeding
• allergies toward study medication, or medication in a standard treatment
• contralateral surgery (lumpectomy/mastectomy) at time of mastectomy
• surgery cannot be performed

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative; Postoperative Nausea and Vomiting; Systemic Inflammatory Response Syndrome; Postoperative Complications

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Inflammation; Shock

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: kristin steinthorsdottir, md
• Organization: rigshospitalet

kjs@dadlnet.dk

31666112

Study Officials

• Kristin J Steinthorsdottir, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD, Clinical assistant

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 24, 2017
• Study Start: March 27, 2017
• Primary Completion: April 22, 2018
• Study Completion: April 22, 2018
• Last Updated: December 2, 2019
• Results First Posted: December 2, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)