Symptoms and General Pathology

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Breast Neoplasms

Lymphoma

Hodgkin Disease

Breast Diseases

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Lymphosarcoma

Hodgkin Lymphoma

Patients underwent simple mastectomy, skin-sparing or nipple-sparing mastectomy and implant-based, two-stage breast reconstruction: contextual mastectomy and expander positioning were performed during first stage (stage I) while substitution of the expander with definitive implant occurred during second stage (stage II). Fat grafting with regenerative intent was performed during stage I or between stage I and II. Adipose tissue was harvested from the abdomen, flanks, trochanter regions, inner thigh and medial aspect of knees. Fat was injected in the subfascial plane of the pectoralis major muscle with blunt cannula in order to avoid thrombo-embolic risks. At least six months after stage I patients underwent expander substitution with definitive implant and contralateral mammoplasty when required. In case of complications that required removal of the implant, autologous reconstruction was performed.

Implant-based breast reconstruction and fat grafting after salvage or prophylactic mastectomy in patients previously exposed to radiation therapy on the breast as adjuvant treatment after breast conserving surgery (BCS) or on thoracic wall for Hodgkin Lymphoma (HL).

Immediate tissue expander and lipofilling after mastectomy

Chiara Listorti, MD

Secondo Folli, MD

Higher rates of complications and poorer cosmetic outcomes have been reported after salvage mastectomy and implant-based versus autologous reconstruction in patients previously exposed to radiation therapy (i) on the breast as adjuvant treatment after breast conserving surgery (BCS) or (ii) on thoracic wall for Hodgkin Lymphoma (HL). Nevertheless, selected patients with favourable preoperative soft-tissue assessment may benefit from alloplastic reconstruction and fat grafting that has been suggested as an effective technique to promote the regeneration of irradiated tissues.

The aims of this study are to assess:

1. the feasibility of implant-based breast reconstruction and fat grafting after mastectomy (simple mastectomy, nipple-sparing and skin-sparing mastectomy)
2. oncological safety of implant-based breast reconstruction and fat grafting.

National Comprehensive Cancer Network guidelines recommend autologous reconstruction as the preferred breast reconstruction after mastectomy in previously irradiated patients because of higher complication rates and worse aesthetic outcomes as compared to immediate breast implant reconstruction. In fact, unacceptable rates of complications (60-70%) have been reported by first experiences. Instead, autologous reconstruction showed lower complication rates as compared to implant-based breast reconstruction (25.5% vs 50.9%). However, it may not be indicated in patients with previous surgery at the donor site or in case of other contraindications, requires longer surgical time and is at risk of donor-site morbidity and loss of sensation.

On the other hand, fat grafting improves softness of tissues and scars, releasing their rigidity and for these effects it has been studied for effectively promoting the regeneration of irradiated tissues, enlarging the envelope thickness for safety reasons, optimizing cosmetic outcomes and ultimately increasing patient comfort and quality of life.

Therefore, a surgical technique combining implant-based breast reconstruction after mastectomy and fat grafting may favor alloplastic reconstruction in selected patients.

The investigators enroll patients candidate to mastectomy and breast reconstruction who had received prior adjuvant radiation therapy after breast conserving surgery (BCS) or radiation therapy for the treatment of Hodgkin Lymphoma (HL).

Aims of the study are to investigate (i) the feasibility of implant-based breast reconstruction and fat grafting after mastectomy (simple mastectomy, nipple-sparing and skin-sparing mastectomy); (ii) the oncological safety of implant-based breast reconstruction and fat grafting.

Implant-based Breast Reconstruction and Mastectomy With Fat Grafting After Breast Conserving Surgery and Radiotherapy

Immediate Tissue Expander and Lipofilling After Mastectomy for Breast Cancer Recurrence Following Lumpectomy and Irradiation: Retrospective Multicentric Clinical Trial

Identification of complication rates after stage I and II, measuring percentage of complications (pain and patient discomfort, partial necrosis of mastectomy flaps, nipple-areolar necrosis, delayed wound healing, capsular contracture, bleeding, expander or implant exposition, infection, expander rupture, re-operations, reconstruction failures) over the total number of surgical procedures of stage I and II.

Self-assessed patient reports for identification of patient's satisfaction, measuring percentage of patients that were satisfied with results overall.

Clinical and photography-based assessments for cosmetic outcomes measurement graded by a plastic breast surgeon as excellent, very good, good, fair, or poor.

Identification of rate of loco-regional and distant metastases.

Morgagni Pierantoni Hospital

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Before and after the AFT surgery, patients are required to wear the EVEBRA expansion device for a total duration of 4 weeks. Thereafter patients will receive a PexyBra over the reconstructed breast.

Pre-operatively patients are required to wear the device for a total of 200 hours.

Patients will receive the AFT treatment for total reconstruction without the requirement of wearing the EVEBRA device.

Wear 2 weeks pre-operatively for a total duration of 200 hours. Wear 2 weeks post-operatively for 10 hours a day.

EVEBRA device

Maud Rijkx, MD, MsC

Andrzej Piatkowski, MD, PhD

Jan Maerten Smit, MD, MsC

Ute Schmidbauer, MD, PhD

Andrzej Piatkowski de Gryzmala, MD, MsC

This multicentre randomized controlled trial aims to evaluate a new breast reconstruction technique- autologous fat transfer (AFT). Female patients with breast cancer schedule to receive a mastectomy (or having undergone mastectomy in the past) will be randomized to undergo breast reconstruction with either AFT with the EVEBRA device(intervention group) or AFT without the EVEBRA device (control group). AFT will be evaluated in terms of volume, quality of life, aesthetic result, complications and oncological safety.

External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery

External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery

All women will have an MRI for Baseline Breast Volume measurement at the time of enrollment. Final breast volume will be also determined by MRI 6 months after the first grafting procedure (AFT#1).

The primary effectiveness endpoint is the Percentage Augmentation of the mastectomy defect at 12 months after AFT#1.

Presence + description of necrotic cysts (Scale: amount of cyst and size in centimeters)

Qscore will be used to assess final scores. As described in the BREAST-Q Module, summed scores will be converted into a score from 0 (worst) to 100 (best) per domain. Higher scores reflect a better outcome.

The aesthetic improvement will be rated using pre-operative and one year post-operative 2D images by a group of experts, breast cancer patients and age-matched male and female laymen. All parties rate the pre-/post- 3D images on a Likert scale (5 points) with one indicating no improvement and 5 indicating perfect improvement.

Cup size before and after reconstruction will be noted .

Volume change will be noted in cubic centimetre(cc)

ZonMw: The Netherlands Organisation for Health Research and Development

Maastricht University Medical Center

Wounds and Injuries

Radiation Injuries

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.

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.

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

Fat grafting

Antonio Forte, MD, PhD

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.

Adipose-Induced Regeneration of Breast Skin to Treat Post-Mastectomy Radiation Injury in Breast Cancer Patients

Adipose-Induced Regeneration of Breast Skin (AIR Breast) to Treat Post-Mastectomy Radiation Injury in Breast Cancer Patients: A Randomized, Prospective Pilot Study

Number of subjects to show reverse radiation-induced skin injury

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.

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.

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.

Mayo Clinic

Lymphedema

Breast Cancer Lymphedema

Lymphatic Diseases

Postoperative Complications

Treatment of breast cancer related lymphedema by fat grafting

Fat Grafting

Minqiang Xin, MD

Chenglong Wang, MD

Jie Luan, MD

Breast cancer related lymphedema (BRCL) is a common complication following breast cancer treatment. The incidence of BRCL ranges from 6-50%, depending on the surgical procedure in the axilla and the type of the radiation therapy. BRCL can causes cosmetic deformities, impaired physical mobility, mental discomfort, reduced quality of life and erysipelas. Therapy of BRCL is divided into conservative and operative methods. However, all the above method has some shortcomings. It is urgent to investigate new approaches to treat BRCL. In this study, fat grafting is to be used for the treatment of BRCL, and the efficacy and safety of this method will be also assessed.

Fat Grafting Used for the Treatment of Breast Cancer Related Lymphedema in China

All the patients who received treatment are scanned by 3 dimensional camera, then the volume measurement of the affected and normal arm is managed by software

The affected and normal arms of the patients who received treatment are assessed by multi-frequency bioelectrical impedance analysis

The affected arms of the patients who received treatment was assessed by indocyanine green lymphography

Any side effects of experimental treatment. The patients who received treatment are asked at each visit

The patients who received treatment are asked to fill in a questionnaire (EQ-5D- 5 L-questionnaire)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Implant-based Breast Reconstruction and Mastectomy With Fat Grafting After Breast Conserving Surgery and Radiotherapy	NCT06119633	Breast Cancer	Immediate tissu...	18 Years - 75 Years	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery	NCT05003635	Breast Cancer F...	EVEBRA device	23 Years - 69 Years	Maastricht University Medical Center
Implant-based Breast Reconstruction and Mastectomy With Fat Grafting After Breast Conserving Surgery and Radiotherapy	NCT06119633	Breast Cancer	Immediate tissu...	18 Years - 75 Years	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Adipose-Induced Regeneration of Breast Skin to Treat Post-Mastectomy Radiation Injury in Breast Cancer Patients	NCT03981718	Breast Cancer	Fat grafting	18 Years -	Mayo Clinic
External Vacuum Expansion: Evaluation in Breast Reconstructive Surgery Evaluation in Breast Reconstructive Surgery	NCT05003635	Breast Cancer F...	EVEBRA device	23 Years - 69 Years	Maastricht University Medical Center
Fat Grafting Used for the Treatment of Breast Cancer Related Lymphedema in China	NCT02981485	Breast Cancer L...	Fat Grafting	20 Years - 60 Years	Peking Union Medical College
Adipose-Induced Regeneration of Breast Skin to Treat Post-Mastectomy Radiation Injury in Breast Cancer Patients	NCT03981718	Breast Cancer	Fat grafting	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for fat grafting

Every month we try and update this database with for fat grafting cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.