A Prospective, Randomized Study of the Possible Pain Relieving and Scar Tissue Modifying Properties of Lipotransplantation in a "Post Breast Therapy Pain Syndrome" Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Pain in the mastectomy area
研究概览
简要总结
Background
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.
Hypotheses
- 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.
Patients
Women who have undergone treatment for breast cancer and subsequently developed PBTPS. A total of 32 patients with PBTPS will be included.
Methods
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.
Conclusion
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.
详细描述
Background
In Denmark, breast cancer is the most common fatal cancer in women with more than 4700 new cases annually. All patients are treated according to national guidelines developed by the Danish Breast Cancer Cooperative Group (DBCG). Treatment primarily consists of surgical removal of all or parts of the breast and simultaneous removal of one-or lymph nodes in the ipsilateral axilla. Subsequently, there may be a need for additional treatment with chemotherapy, radiation and / or anti-hormonal therapy, in order to reduce the risk of recurrence.
Up to 60% of women who are treated surgically for breast cancer, will experience chronic pain as a consequence of the treatment. This condition was previously referred to as "Post Mastectomy Pain Syndrome", but because the condition is also seen after less extensive forms of breast cancer surgery, the condition is now termed "Post Therapy Breast Pain Syndrome" (PBTPS). PBTPS is defined as a neuropathic pain condition with pain localized to the axilla, the medial part of the upper arm, chest and or chest wall of the side of surgery, lasting more than three months after surgery and / or the end of treatment.
In 2011 Caviggioli et al. published a study where lipotransplantation to the mastectomy area was found to have a significant analgesic effect. The aforementioned study is to date the only published study in the field. However, it is not a randomized study. In order to obtain further evidence of the apparent beneficial effect of lipotransplantation on pain, the present study has been initiated.
Lipotransplantation is a fast and relatively non-invasive technique which is described in detail by Coleman et al.. Additionally, in a study from 2008, Klinger et al. found that lipotransplantation to burn scars in the face resulted in a significant improvement in the patient's skin and scar quality and also reduced pain in the treated areas. The theoretical basis for the scar and skin modifying effects of lipotransplantation has not yet been finally understood. To the best of our knowledge, no studies have systematically investigated and analysed the effects of lipotransplantation on the irradiated mastectomy area on a histological level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Previous diagnosed with and finished treatment for breast cancer
- •Unilateral mastectomized
- •Finished post operative radiotherapy minimum 6 months ago, if applicable.
- •Pain in the area around the missing breast for minimum three months after radiotherapy was finished
- •Pain equal to or above 3 on the Numeric Rating Scale for pain
- •Verbal and written informed consent
排除标准
- •Active breast cancer recurrence
- •Other cancer disease
- •Pain in the region around the removed breast before the mastectomy
- •Active smokers
- •Psychiatric illness that prevents informed consent
- •Not able to understand and speak Danish
- •Patients diagnosed with generalized pain conditions
结局指标
主要结局
Pain in the mastectomy area
时间窗: 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.
次要结局
- Elastin content in the mastectomy scar(One year)
- Free nerve endings crossing between the dermis and the epidermis(One year)
- Collagen in the mastectomy scar(One year)
- Mastectomy scar quality(One year)
- Analgesic consumption(One year)
研究者
Alexander Juhl Andersen
M.D.
Aarhus University Hospital