Breast CancerNCT03981718
Adipose-Induced Regeneration of Breast Skin to Treat Post-Mastectomy Radiation Injury in Breast Cancer Patients
A study testing Fat grafting in people with Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to identify the therapeutic effect of injection into the subcutaneous tissue to treat radiation-induced skin injury of post mastectomy in patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Fat grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2019to 15 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females above 18 years old
- Diagnosis with breast cancer, who will be treated by mastectomy and undergo radiotherapy, and will receive breast reconstruction
- Able and willing to sign consent to participate
Who cannot join
- Breast cancer patients that do not accept to participate
- Patients with previous breast reconstruction surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adipose-Induced Regeneration of Breast Skin (AIR Breast) to Treat Post-Mastectomy Radiation Injury in Breast Cancer Patients: A Randomized, Prospective Pilot Study
Researchers are trying to identify the therapeutic effect of injection into the subcutaneous tissue to treat radiation-induced skin injury of post mastectomy in patients with breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Fat grafting
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat graftingProcedure or surgery
Lipoaspirates will be collected from the own subjects abdominal fat tissue, during the 2nd stage breast reconstruction and will be injected on each affected breast during the insertion of the permanent breast implant in the 2nd stage of breast reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Group: Standard | Active comparator | 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. Receives: Procedure: Fat grafting |
| Group: Experimental | Experimental | 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. Receives: Procedure: Fat grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in skin quality
Number of subjects to show reverse radiation-induced skin injury
Measured: 18 months
Physical Well-Being Using the BREAST-Q Reconstruction Module
Change in BREAST-Q patient-reported questionnaire to assess quality of life and patient satisfaction by using questions pertaining to the function and participation in activities after fat grafting. Subjects are asked to answer 16 questions on how often they experienced each symptom, using a score of 1 to 5, where 1 was none of the time and 5 was very often. Answers from these questions were combined to provide a total physical well-being score (for a total possible range of 16-80). Lower scores reflected fewer symptoms and higher satisfaction where higher scores reflected more symptoms and less satisfaction.
Measured: 12 months, 18 months
Effects of skin disease on quality of life
Change in patient-reported Skin-16 questionnaire used to assess skin condition after fat grafting by using 16 questions on how often subjects skin condition has bothered them during the past week, using a score of 0 to 6, where 0 is never bothered and 10 is always bothered.
Measured: 12 months, 18 months
Skin Toxicity Costs
Change in patient-reported skin toxicity costs questionnaire used to assess the economic impact of skin changes due to radiation after fat grafting by using 7 questions asking subjects to report total costs and itemized spending on specific items related to post procedure care.
Measured: 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start17 May 2019
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Why it stopped: low/slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Forte, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981718
- Sponsor's protocol ID
- 19-002792
- Other IDs
- NCI-2022-11026
- Status last verified
- Jan 2024
- First submitted
- 7 Jun 2019
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose-Induced Regeneration of Breast Skin (AIR Breast) to Treat Post-Mastectomy Radiation Injury in Breast Cancer Patients: A Randomized, Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT03981718
- Acronym / sponsor ID
- 19-002792
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: low/slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 17 May 2019 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 11 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are trying to identify the therapeutic effect of injection into the subcutaneous tissue to treat radiation-induced skin injury of post mastectomy in patients with breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group: Standard | Active comparator | Procedure: Fat graftingBreast 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. |
| Group: Experimental | Experimental | Procedure: Fat graftingBreast 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females above 18 years old
- Diagnosis with breast cancer, who will be treated by mastectomy and undergo radiotherapy, and will receive breast reconstruction
- Able and willing to sign consent to participate
Key exclusion criteria (2 listed)
- Breast cancer patients that do not accept to participate
- Patients with previous breast reconstruction surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fat graftingLipoaspirates will be collected from the own subjects abdominal fat tissue, during the 2nd stage breast reconstruction and will be injected on each affected breast during the insertion of the permanent breast implant in the 2nd stage of breast reconstruction | Procedure or surgery | Group: Experimental, Group: Standard |
Primary outcome
Increase in skin quality
Time frame: 18 months
Number of subjects to show reverse radiation-induced skin injury
Physical Well-Being Using the BREAST-Q Reconstruction Module
Time frame: 12 months, 18 months
Change in BREAST-Q patient-reported questionnaire to assess quality of life and patient satisfaction by using questions pertaining to the function and participation in activities after fat grafting. Subjects are asked to answer 16 questions on how often they experienced each symptom, using a score of 1 to 5, where 1 was none of the time and 5 was very often. Answers from these questions were combined to provide a total physical well-being score (for a total possible range of 16-80). Lower scores reflected fewer symptoms and higher satisfaction where higher scores reflected more symptoms and less satisfaction.
Effects of skin disease on quality of life
Time frame: 12 months, 18 months
Change in patient-reported Skin-16 questionnaire used to assess skin condition after fat grafting by using 16 questions on how often subjects skin condition has bothered them during the past week, using a score of 0 to 6, where 0 is never bothered and 10 is always bothered.
Skin Toxicity Costs
Time frame: 12 months, 18 months
Change in patient-reported skin toxicity costs questionnaire used to assess the economic impact of skin changes due to radiation after fat grafting by using 7 questions asking subjects to report total costs and itemized spending on specific items related to post procedure care.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Forte, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fat grafting in people with Breast Cancer, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in skin quality (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.