Dex-Fib: Dexamethasone for Post Uterine Artery Embolization Pain

Sponsor

University of Miami (Other)

Overall Status

Recruiting

CT.gov ID

NCT04655144

Collaborator

(none)

Enrollment

Location

Arms

46.7

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research is to investigate if administration steroids (anti-inflammatory medication) via the uterine arteries during uterine fibroid embolization (A non surgical procedure for treating uterine fibroids by blocking their blood supply) can help reduce the pain, nausea, vomiting, and general feeling of weakness following the procedure.

Condition or Disease	Intervention/Treatment	Phase
Leiomyoma	Drug: Dexamethasone Drug: Saline	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Intra-Arterial Dexamethasone for the Alleviation of Pain and Postembolization Syndrome Following Uterine Artery Embolization

Actual Study Start Date :

Jan 25, 2021

Anticipated Primary Completion Date :

Dec 15, 2024

Anticipated Study Completion Date :

Dec 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexamethasone Arm A total of 5mg dexamethasone will be administered into each uterine artery (10mg total) prior to uterine artery embolization.	Drug: Dexamethasone Dexamethasone delivered to the uterine arterial bed, prior to embolization.
Placebo Comparator: Saline Arm A volume of normal saline, equal to the total volume delivered in the Dexamethasone Arm, will be administered into each uterine artery prior to uterine artery embolization.	Drug: Saline Saline delivered to the uterine arterial bed, prior to embolization.

Arm

Intervention/Treatment

Experimental: Dexamethasone Arm

A total of 5mg dexamethasone will be administered into each uterine artery (10mg total) prior to uterine artery embolization.

Drug: Dexamethasone

Dexamethasone delivered to the uterine arterial bed, prior to embolization.

Placebo Comparator: Saline Arm

A volume of normal saline, equal to the total volume delivered in the Dexamethasone Arm, will be administered into each uterine artery prior to uterine artery embolization.

Drug: Saline

Saline delivered to the uterine arterial bed, prior to embolization.

Outcome Measures

Primary Outcome Measures

Pain scores using the VAS Questionnaire [Day 7]
Pain is measured using a modified Visual Analogue Score (VAS), which has a total score ranging from 0 (no pain at all) to 10 (worst pain).

Secondary Outcome Measures

Severity of post-embolization syndrome symptoms [Day 7]
Post embolization Syndrome (PES) symptomatology will be assessed using a PES survey
Change in uterine fibroid volume [Baseline, 3 months]
As evaluated via magnetic Resonance Imaging (MRI) using volumetric software
Change in symptoms [Baseline, 3 months]
Change in participant symptoms will be assessed using the Uterine Fibroid Embolization (UFE) Quality of Life and Symptomatology Survey with a total subsection score ranging from 8-40 with the higher score indicating a patient-perceived improvement in symptomatology.
Change in quality of life [Baseline, 3 months]
Change in participant quality of life will be reported using the Uterine Fibroid Embolization (UFE) Quality of Life and Symptomatology Survey with a total subsection score ranging from 0-6 with the highest score indicating the best positive response.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women who meet criteria to undergo uterine fibroid embolization for symptomatic fibroids.

Exclusion Criteria:

Currently pregnant or actively attempting to conceive
Those deemed mentally impaired to make their own medical decisions
Previous documented allergy to dexamethasone
Those currently taking daily steroids for any reason
Those with diabetes or deemed to be pre-diabetic
Those with contraindications for angiography
Prisoners

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sylvester Comprehensive Cancer Center	Miami	Florida	United States	33136

Sponsors and Collaborators

University of Miami

Investigators

Principal Investigator: Prasoon Mohan, MD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prasoon Mohan, Associate Professor, University of Miami

ClinicalTrials.gov Identifier:

NCT04655144

Other Study ID Numbers:

20200788

First Posted:

Dec 7, 2020

Last Update Posted:

Mar 25, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Prasoon Mohan, Associate Professor, University of Miami

Fibroids

Leiomyoma

post-embolization pain

dexamethasone

Additional relevant MeSH terms:

Leiomyoma

Myofibroma

Dexamethasone

Study Results

No Results Posted as of Mar 25, 2022