OPEN Research Support
head

Physician
Martin Sollie
Department of Plastic Surgery, University Hospital Odense


Projekt styring
Projekt status    Sampling ongoing
 
Data indsamlingsdatoer
Start 14.08.2017  
Slut 30.06.2019  
 



Autologous fat transplant as treatment for Post Mastectomy Pain-Syndrome. A randomized controlled trial

Short summary

Chronic pain after breast cancer affects many women after undergoing surgery for this disease. A specific syndrome called "Post Mastectomy Pain Syndrome" (PMPS) has therefore been defined. The treatment modalities on PMPS are limited and the effect of today's treatment regimens are also scarce.

There is therefore a need for more effective treatments for these chronic pains.

Autologous fat transplant is a promising new treatment that may play an important role in tomorrows treatment of PMPS. This RCT aims to investigate the possible effect of an autologous fat transplant on PMPS.


Rationale

Chronic pain after surgery for breast cancer is an increasing problem as more and more women are affected by the disease. Post mastectomy pain-syndrome is a well-recognized complication that is reported in up to 70% of women undergoing surgery for breast cancer. The available treatment modalities such as analgesics and other alternative methods are usually not effective when trying to reduce these pains. The need for more effective treatment is therefore significant.

Several studies have suggested the use of autologous fat transplant as treatment for post mastectomy pain-syndrome. The fat is harvested, either from the abdomen or thighs, and injected into the area of scar tissue. The level of evidence of these previously published studies is, however, low, and more research is needed.

The exact mechanism of autologous fat transplants effect on pain is not clearly understood. The leading theory is that the stem cells embedded in the fat along with their secretion of growth factors play an important role.

This study aims to investigate the effect of an autologous fat transplant as treatment for post- mastectomy pain syndrome. It is designed as a randomized controlled trial including 40 patients affected by this syndrome.  

The 40 participants will be randomized into two groups, the intervention group and the control group. All participants will undergo surgery, having liposuction performed either on the abdomen or the thighs. The intervention group will have some of the fat injected into the area of pain, whilst the control group will have saline solution injected. 


Description of the cohort

The cohort consists of women treated surgically for breast cancer with mastectomy, suffering from chronic pain from the surgical area. The women have undergone either simple mastectomy or radical mastectomy. 

All included women were originally treated at Odense University Hospital, Odense.


Data and biological material

Our study aim to report on the following outcomes:

Primary:

  • Pain in scar tissue (Numeric scale/ VAS -scale)

Secondary:

  • Pain treatment - medical and other (Specifically designed questionnaire)
  • Neuropathic Pain (Neuropathic Pain Symptom Inventory scale)

  • Health Related Quality of Life (SF-36)


Collaborating researchers and departments

Department of Plastic Surgery, Odense University Hospital and Department of Plastic Surgery, Sygehus Lillebaelt

  • Consultant Jørn Bo Thomsen, PhD
Department of Plastic Surgery, Odense University Hospital
  • Consultant and professor Jens Ahm Sørensen, PhD
  • Consultant Camilla Bille, PhD