Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigation of the Pain Relieving Properties of Lipotransplantation After Treatment for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01888419
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : February 15, 2016
Sponsor:
Collaborator:
University of Aarhus
Information provided by (Responsible Party):
Alexander Juhl Andersen, Aarhus University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chronic Pain Other: Lipotransplantation Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: No active treatment
Clinical follow-up, no active intervention.
Experimental: Lipotransplantation
Lipotransplantation in general anaesthesia to the mastectomy site.
Other: Lipotransplantation
Lipotransplantation in general anaesthesia to the mastectomy site
Other Names:
  • Fat grafting
  • Fat transplantation




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Collagen in the mastectomy scar [ Time Frame: One year ]
    Changes in the proportions of collagen type I and III in the mastectomy scar.

  2. Elastin content in the mastectomy scar [ Time Frame: One year ]
    Changes in the elastin content of the mastectomy scar.

  3. 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.

  4. Mastectomy scar quality [ Time Frame: One year ]
    Changes in the mastectomy scar quality, measured using the Patient and Observer Scar Assessment Scale.

  5. Analgesic consumption [ Time Frame: One year ]
    Changes in the analgesic consumption of the patients included in the study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Denmark
Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
University of Aarhus
Investigators
Layout table for investigator information
Principal Investigator: Alexander Juhl Andersen, M.D. University of Aarhus

Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Alexander Juhl Andersen, M.D., Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01888419     History of Changes
Other Study ID Numbers: PBTPS 1-10-72-76-13
First Posted: June 27, 2013    Key Record Dates
Last Update Posted: February 15, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Alexander Juhl Andersen, Aarhus University Hospital:
Post Breast Therapy Pain Syndrome
Lipotransplantation
Breast Cancer
Pain

Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms