Investigation of the Pain Relieving Properties of Lipotransplantation After Treatment for Breast Cancer
CompletedNot applicableNCT01888419
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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…
Study details
- 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
- Conditions
- Interventions
- Other: Lipotransplantation
- Sponsor
- Aarhus University Hospital
- Collaborators
- University of Aarhus
- Start date
- 2014-10
- Primary completion
- 2016-01
- Sex
- Female
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Denmark
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01888419