Dexamethasone for Post Uterine Artery Embolization Pain (Dex-Fib)
Primary Purpose
Leiomyoma
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Leiomyoma focused on measuring Fibroids, Leiomyoma, post-embolization pain, dexamethasone
Eligibility Criteria
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
Sites / Locations
- Sylvester Comprehensive Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexamethasone Arm
Saline Arm
Arm Description
A total of 5mg dexamethasone will be administered into each uterine artery (10mg total) prior to uterine artery embolization.
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.
Outcomes
Primary Outcome Measures
Pain scores using the VAS Questionnaire
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
Post embolization Syndrome (PES) symptomatology will be assessed using a PES survey
Change in uterine fibroid volume
As evaluated via magnetic Resonance Imaging (MRI) using volumetric software
Change in symptoms
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
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.
Full Information
NCT ID
NCT04655144
First Posted
December 2, 2020
Last Updated
February 13, 2023
Sponsor
University of Miami
1. Study Identification
Unique Protocol Identification Number
NCT04655144
Brief Title
Dexamethasone for Post Uterine Artery Embolization Pain
Acronym
Dex-Fib
Official Title
Intra-Arterial Dexamethasone for the Alleviation of Pain and Postembolization Syndrome Following Uterine Artery Embolization
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
December 15, 2024 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyoma
Keywords
Fibroids, Leiomyoma, post-embolization pain, dexamethasone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone Arm
Arm Type
Experimental
Arm Description
A total of 5mg dexamethasone will be administered into each uterine artery (10mg total) prior to uterine artery embolization.
Arm Title
Saline Arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone delivered to the uterine arterial bed, prior to embolization.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Saline delivered to the uterine arterial bed, prior to embolization.
Primary Outcome Measure Information:
Title
Pain scores using the VAS Questionnaire
Description
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).
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Severity of post-embolization syndrome symptoms
Description
Post embolization Syndrome (PES) symptomatology will be assessed using a PES survey
Time Frame
Day 7
Title
Change in uterine fibroid volume
Description
As evaluated via magnetic Resonance Imaging (MRI) using volumetric software
Time Frame
Baseline, 3 months
Title
Change in symptoms
Description
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.
Time Frame
Baseline, 3 months
Title
Change in quality of life
Description
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.
Time Frame
Baseline, 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lia Quezada, MD
Phone
305-243-2210
Email
LQuezada@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prasoon Mohan, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lia Quezada
Phone
305-243-2210
Email
LQuezada@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Prasoon Mohan, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dexamethasone for Post Uterine Artery Embolization Pain
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