Investigation of the Pain Relieving Properties of Lipotransplantation After Treatment for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01888419|
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : February 15, 2016
In Denmark, breast cancer is the most common fatal cancer in women with more than 4700 new cases annually. Unfortunately, up to 60% of women who are treated surgically for breast cancer, will experience chronic pain as a consequence of the treatment. This state of chronic neuropathic pain is termed "Post Breast Therapy Pain Syndrome" or PBTPS.
The purpose of the study
The purpose of this study is to investigate whether transplantation of fat cells (lipotransplantation) to the pain affected mastectomy area, could have an analgesic effect in women who have developed PBTPS. Secondary, we wish to investigate if lipotransplantation has a beneficial effect on the quality of the skin and the scar in the area where the transplanted fat cells are placed.
- Lipotransplantation to the area under the scar tissue and the area under the pain-afflicted area reduces the pain in women with PBTPS.
- The neuropathic pain in PBTPS is correlated to the number of free nerve endings crossing the border between the dermis and the epidermis
- Lipotransplantation have a beneficial effect on the scar tissue structure and improves the skin quality.
Women who have undergone treatment for breast cancer and subsequently developed PBTPS. A total of 32 patients with PBTPS will be included.
Patients will be randomly assigned to receive either lipotransplantation or no active treatment. At three follow-up visits, the perceived pain of the patient and the skin and scar quality will be scored. In addition, a 3-mm biopsy will be taken from the skin on both the missing and the healthy breast, and from the mastectomy scar.
The scoring of the perceived pain and the quality of the skin and the scar, allows us to investigate if the lipotransplantation have an effect on pain, and skin/scar quality. Additionally, the skin and scar biopsies will be examined on a microscopic level, in order to investigate why lipotransplantation has these effects.
In summary, the results of this project could help to increase our understanding of why some patients develop chronic neuropathic pain after mastectomy and radiotherapy. It is our hope that our results may contribute to the development of better and more effective treatment that will be beneficial for the project participants and future patients.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Other: Lipotransplantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized Study of the Possible Pain Relieving and Scar Tissue Modifying Properties of Lipotransplantation in a "Post Breast Therapy Pain Syndrome" Setting|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
No Intervention: No active treatment
Clinical follow-up, no active intervention.
Lipotransplantation in general anaesthesia to the mastectomy site.
Lipotransplantation in general anaesthesia to the mastectomy site
- Pain in the mastectomy area [ Time Frame: one year ]The pain in the area around the mastectomy will be measured using visual analog scales (DoloTest), at inclusion of the patient, and at three follow-up visits 3, 6 and 12 months after inclusion.
- Collagen in the mastectomy scar [ Time Frame: One year ]Changes in the proportions of collagen type I and III in the mastectomy scar.
- Elastin content in the mastectomy scar [ Time Frame: One year ]Changes in the elastin content of the mastectomy scar.
- Free nerve endings crossing between the dermis and the epidermis [ Time Frame: One year ]Changes in the number of free nerve endings crossing the border between the dermis and the epidermis per millimeter in the skin of the pain afflicted area around the mastectomy scar.
- Mastectomy scar quality [ Time Frame: One year ]Changes in the mastectomy scar quality, measured using the Patient and Observer Scar Assessment Scale.
- Analgesic consumption [ Time Frame: One year ]Changes in the analgesic consumption of the patients included in the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888419
|Aarhus University Hospital|
|Aarhus C, Denmark, 8000|
|Principal Investigator:||Alexander Juhl Andersen, M.D.||University of Aarhus|