Breast NeoplasmsNCT02637635
Does Autologous Fat Transplantation Improve Results and Reduce Complications in Breast Reconstruction With Implants?
A study testing Autologous fat transplantation and Expander prosthesis in people with Breast Neoplasms, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to determine if autologous fat transplantation as a pre-treatment gives better results in breast reconstruction with implants after mastectomy and radiotherapy. One group is randomized to conventional reconstruction with implant and one to pre-treatment prior reconstruction with implant. Read more about this study
- Who is it for?
- Ages 25 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Autologous fat transplantation and Expander prosthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2012to Jan 2020
- 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 25 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously undergone mastectomy and adjuvant radiotherapy.
- Will undergo breast reconstruction with expander prosthesis.
- Mammogram and ultrasound performed maximum three month prior surgery.
- At least one year since last operation or radiotherapy.
Who cannot join
- Known breast cancer relapse
- Distant metastases except axillary
- Any contraindication for anaesthesia
- Systemic disease such as diabetes mellitus type I.
- BMI >30 (if the patients lose weight they are eligible)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Department of Molecular Medicine and Surgery, Karolinska University Hospital, Department of Reconstructive Plastic Surgery
Stockholm, 17177
About this study
Official title: Does Pre-treatment With Autologous Fat Transplantation Improve Results and Reduce Complication Rate After Breast Reconstruction With Implants? A Randomized Controlled Study
The purpose of this study is to determine if autologous fat transplantation as a pre-treatment gives better results in breast reconstruction with implants after mastectomy and radiotherapy. One group is randomized to conventional reconstruction with implant and one to pre-treatment prior reconstruction with implant.
Our aims are:
- To study whether lipofilling can decrease the number of reoperations and complications such as postoperative infections or not.
- Evaluate the aesthetic results and the patients' experiences. For both these aims the hypothesis is that pre-treatment is in favour for the outcomes.
Read the detailed description
All patients will undergo breast reconstruction with expander implant. Half of the patients will be randomized to pre-treatment with lipofilling before the reconstruction. The randomization will be carried out with block randomization. A certain person that has not met the patients has been assigned to do this.
Fat transplantation: The fat will be harvested manually with dry technique using a Coleman cannula on a 10 ml syringe. There after the syringes and fat are centrifuged at 3000 rpm for 3 minutes. Liquid fat from lysed cells and blood will be separated from the purified fat cells and discarded. The fat graft will then be injected fan-shaped in multiple layers into the subcutaneous tissues of the breast using another blunt cannula with a diameter of 1.29 mm. If necessary to obtain a volume of 100 ml fat injected the procedure will be repeated. All sessions will be performed under general anesthesia in day surgery. Three month later the patients will undergo breast reconstruction with expander prosthesis.
Those patients that are randomized to not undergo pre-treatment will undergo breast reconstruction with expander prosthesis immediately.
After the reconstruction all patients will have as many appointments as necessary for expansion with a breast nurse at our clinic. If necessary the patient will also meet the surgeon. After the month the patients have a routine doctors appointment. After 6, 12 and 24 month the patients will be followed up with objective measurements of breast symmetry and they will fill in quality of life formularies. In this study we are using the validated formulary called Breast Q and a study specific formulary. At 24 month standardized photos of the breasts will be taken.
- Conditions
- Breast Neoplasms
- Being tested
- Autologous fat transplantation, Expander prosthesis
- Keywords
- Mammaplasty, Transplantation, Autologous, Mastectomy, Breast Implants, Radiotherapy, Adjuvant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous fat transplantationProcedure or surgery
Also called lipofilling, fat grafting, lipomodelling
100 ml of autologous fat will be injected to the reconstruction area 3 month prior the breast reconstruction with expander prosthesis.
Expander prosthesisProcedure or surgery
Also called implant
breast reconstruction with expander prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Breast reconstruction with implant | Experimental | The patients will undergo breast reconstruction with an expander prosthesis. Receives: Procedure: Expander prosthesis |
| Autologous fat transplantation | Experimental | The patients will undergo lipofilling as a pre-treatment before they will undergo breast reconstruction with an expander prosthesis. Receives: Procedure: Autologous fat transplantation; Procedure: Expander prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of reoperations
Measured: Two years on from reconstruction with prosthesis
Frequency of complications
Measured: Two years on from reconstruction with prosthesis
Secondary outcomes (4)
Total days in hospital during fat transplantation and reconstruction with prosthesis
Number of days spent at the hospital for surgery including both day surgery with fat transplantation and reconstruction with prosthesis.
Measured: 4 month
Number of appointments as outpatient after breast reconstruction.
Number of appointments with surgeon and nurse as outpatient after the reconstructive surgery is performed.
Measured: Two years on from reconstruction with prosthesis
Aesthetic evaluation of the results of the breast reconstruction
Aesthetic outcome is evaluated by plastic surgeons through assessment of standardized photographies of the patients.
Measured: Two years on from reconstruction with prosthesis
Patient reported outcome
Breast Q is a validated questionnaire for quality of life
Measured: Measured at 6, 12 and 24 month from reconstruction with prosthesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startOct 2012
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Marie Wickman Chantereau, Karolinska Institutet
- Investigators
- Inkeri Schultz, PhD, Study chairÅsa Edsander-Nord, Docent, Study chairMarie Wickman Chantereau, Professor, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637635
- Sponsor's protocol ID
- RCTLIP1
- Status last verified
- Apr 2019
- First submitted
- 22 Dec 2014
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Serra-Renom JM, Munoz-Olmo JL, Serra-Mestre JM. Fat grafting in postmastectomy breast reconstruction with expanders and prostheses in patients who have received radiotherapy: formation of new subcutaneous tissue. Plast Reconstr Surg. 2010 Jan;125(1):12-18. doi: 10.1097/PRS.0b013e3181c49458.
PubMed 20048576Rigotti G, Marchi A, Galie M, Baroni G, Benati D, Krampera M, Pasini A, Sbarbati A. Clinical treatment of radiotherapy tissue damage by lipoaspirate transplant: a healing process mediated by adipose-derived adult stem cells. Plast Reconstr Surg. 2007 Apr 15;119(5):1409-1422. doi: 10.1097/01.prs.0000256047.47909.71.
PubMed 17415234Sarfati I, Ihrai T, Kaufman G, Nos C, Clough KB. Adipose-tissue grafting to the post-mastectomy irradiated chest wall: preparing the ground for implant reconstruction. J Plast Reconstr Aesthet Surg. 2011 Sep;64(9):1161-6. doi: 10.1016/j.bjps.2011.03.031. Epub 2011 Apr 22.
PubMed 21514910Mojallal A, Lequeux C, Shipkov C, Breton P, Foyatier JL, Braye F, Damour O. Improvement of skin quality after fat grafting: clinical observation and an animal study. Plast Reconstr Surg. 2009 Sep;124(3):765-774. doi: 10.1097/PRS.0b013e3181b17b8f.
PubMed 19730294
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Pre-treatment With Autologous Fat Transplantation Improve Results and Reduce Complication Rate After Breast Reconstruction With Implants? A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02637635
- Acronym / sponsor ID
- RCTLIP1
- Conditions
- Breast Neoplasms
- Keywords
- Mammaplasty, Transplantation, Autologous, Mastectomy, Breast Implants, Radiotherapy, Adjuvant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- Oct 2012
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 22 Dec 2015 (estimated)
- 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.
The purpose of this study is to determine if autologous fat transplantation as a pre-treatment gives better results in breast reconstruction with implants after mastectomy and radiotherapy. One group is randomized to conventional reconstruction with implant and one to pre-treatment prior reconstruction with implant.
Our aims are:
- To study whether lipofilling can decrease the number of reoperations and complications such as postoperative infections or not.
- Evaluate the aesthetic results and the patients' experiences. For both these aims the hypothesis is that pre-treatment is in favour for the outcomes.
Detailed description
All patients will undergo breast reconstruction with expander implant. Half of the patients will be randomized to pre-treatment with lipofilling before the reconstruction. The randomization will be carried out with block randomization. A certain person that has not met the patients has been assigned to do this.
Fat transplantation: The fat will be harvested manually with dry technique using a Coleman cannula on a 10 ml syringe. There after the syringes and fat are centrifuged at 3000 rpm for 3 minutes. Liquid fat from lysed cells and blood will be separated from the purified fat cells and discarded. The fat graft will then be injected fan-shaped in multiple layers into the subcutaneous tissues of the breast using another blunt cannula with a diameter of 1.29 mm. If necessary to obtain a volume of 100 ml fat injected the procedure will be repeated. All sessions will be performed under general anesthesia in day surgery. Three month later the patients will undergo breast reconstruction with expander prosthesis.
Those patients that are randomized to not undergo pre-treatment will undergo breast reconstruction with expander prosthesis immediately.
After the reconstruction all patients will have as many appointments as necessary for expansion with a breast nurse at our clinic. If necessary the patient will also meet the surgeon. After the month the patients have a routine doctors appointment. After 6, 12 and 24 month the patients will be followed up with objective measurements of breast symmetry and they will fill in quality of life formularies. In this study we are using the validated formulary called Breast Q and a study specific formulary. At 24 month standardized photos of the breasts will be taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast reconstruction with implant | Experimental | Procedure: Expander prosthesisThe patients will undergo breast reconstruction with an expander prosthesis. |
| Autologous fat transplantation | Experimental | Procedure: Autologous fat transplantation, Procedure: Expander prosthesisThe patients will undergo lipofilling as a pre-treatment before they will undergo breast reconstruction with an expander prosthesis. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Previously undergone mastectomy and adjuvant radiotherapy.
- Will undergo breast reconstruction with expander prosthesis.
- Mammogram and ultrasound performed maximum three month prior surgery.
- At least one year since last operation or radiotherapy.
Key exclusion criteria (5 listed)
- Known breast cancer relapse
- Distant metastases except axillary
- Any contraindication for anaesthesia
- Systemic disease such as diabetes mellitus type I.
- BMI >30 (if the patients lose weight they are eligible)
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 |
|---|---|---|
| Autologous fat transplantationAlso: lipofilling, fat grafting, lipomodelling100 ml of autologous fat will be injected to the reconstruction area 3 month prior the breast reconstruction with expander prosthesis. | Procedure or surgery | Autologous fat transplantation |
| Expander prosthesisAlso: implantbreast reconstruction with expander prosthesis. | Procedure or surgery | Autologous fat transplantation, Breast reconstruction with implant |
Primary outcome
Frequency of reoperations
Time frame: Two years on from reconstruction with prosthesis
Frequency of complications
Time frame: Two years on from reconstruction with prosthesis
4 secondary outcomes
Total days in hospital during fat transplantation and reconstruction with prosthesis
Time frame: 4 month
Number of appointments as outpatient after breast reconstruction.
Time frame: Two years on from reconstruction with prosthesis
Aesthetic evaluation of the results of the breast reconstruction
Time frame: Two years on from reconstruction with prosthesis
Patient reported outcome
Time frame: Measured at 6, 12 and 24 month from reconstruction with prosthesis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Background: PubMed 20048576Serra-Renom JM, Munoz-Olmo JL, Serra-Mestre JM. Fat grafting in postmastectomy breast reconstruction with expanders and prostheses in patients who have received radiotherapy: formation of new subcutaneous tissue. Plast Reconstr Surg. 2010 Jan;125(1):12-18. doi: 10.1097/PRS.0b013e3181c49458.
- Background: PubMed 17415234Rigotti G, Marchi A, Galie M, Baroni G, Benati D, Krampera M, Pasini A, Sbarbati A. Clinical treatment of radiotherapy tissue damage by lipoaspirate transplant: a healing process mediated by adipose-derived adult stem cells. Plast Reconstr Surg. 2007 Apr 15;119(5):1409-1422. doi: 10.1097/01.prs.0000256047.47909.71.
- Background: PubMed 21514910Sarfati I, Ihrai T, Kaufman G, Nos C, Clough KB. Adipose-tissue grafting to the post-mastectomy irradiated chest wall: preparing the ground for implant reconstruction. J Plast Reconstr Aesthet Surg. 2011 Sep;64(9):1161-6. doi: 10.1016/j.bjps.2011.03.031. Epub 2011 Apr 22.
- Background: PubMed 19730294Mojallal A, Lequeux C, Shipkov C, Breton P, Foyatier JL, Braye F, Damour O. Improvement of skin quality after fat grafting: clinical observation and an animal study. Plast Reconstr Surg. 2009 Sep;124(3):765-774. doi: 10.1097/PRS.0b013e3181b17b8f.
- Swedish Breast Cancer Group. Provides national guidelines for breast cancer treatment etc.Link provided by the sponsor.
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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.
Inkeri Schultz, PhD study chair
Åsa Edsander-Nord, Docent study chair
Marie Wickman Chantereau, Professor study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous fat transplantation and Expander prosthesis in people with Breast Neoplasms, run by Karolinska Institutet at 1 site in Sweden.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Apr 2019. 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 Sweden. 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?
Results are not available in the source record.
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?
Frequency of reoperations (time frame: Two years on from reconstruction with prosthesis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02637635, which also lists 4 linked publications.
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 17 Apr 2019.