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Fat Grafting for Radiation Injury in Breast Cancer
N/A
Waitlist Available
Led By Antonio Forte, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months, 18 months
Awards & highlights
Study Summary
This trial is testing whether injecting a certain medication into the subcutaneous tissue can help heal radiation-induced skin injury in breast cancer patients who have had a mastectomy.
Who is the study for?
This trial is for women over 18 with breast cancer who will have a mastectomy followed by radiotherapy and plan to get breast reconstruction. They must be willing to consent to participate. Women who've had previous breast reconstructions or don't agree to join are excluded.Check my eligibility
What is being tested?
The study is examining the effectiveness of fat grafting, which involves injecting fat into the skin, as a treatment for radiation-induced skin damage in patients who have undergone mastectomies due to breast cancer.See study design
What are the potential side effects?
Potential side effects of fat grafting may include pain at the injection site, swelling, bruising, infection risk, and possible absorption of some grafted fat back into the body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months, 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months, 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effects of skin disease on quality of life
Increase in skin quality
Physical Well-Being Using the BREAST-Q Reconstruction Module
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group: ExperimentalExperimental Treatment1 Intervention
Breast cancer subjects with current injury to irradiated skin at the post-mastectomy site will receive their fat grafting procedure until 6 months after their 2nd stage breast reconstruction.
Group II: Group: StandardActive Control1 Intervention
Breast cancer subjects with current injury to irradiated skin at the post-mastectomy site will receive fat grafting procedure per standard of care during their 2nd stage breast reconstruction.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fat grafting
2011
Completed Phase 2
~110
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,784 Total Patients Enrolled
82 Trials studying Breast Cancer
13,912 Patients Enrolled for Breast Cancer
Antonio Forte, MD, PhDPrincipal InvestigatorMayo Clinic
5 Previous Clinical Trials
1,070 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had surgery to rebuild your breast in the past.Breast cancer patients who do not want to join the study.Women who are 18 years old or older.You have been diagnosed with breast cancer and are planning to have surgery and radiation therapy, followed by breast reconstruction.
Research Study Groups:
This trial has the following groups:- Group 1: Group: Standard
- Group 2: Group: Experimental
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applications still being accepted for this experiment?
"Unfortunately, this medical trial is not currently open for recruitment. This study was initially posted on May 1st 2023 and last updated on the 25th of May 2022. Nonetheless, there are 2,610 other trials that are actively recruiting patients at this moment in time."
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