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

NCT01888419 | Completed

• 1 other identifier: PBTPS 1-10-72-76-13
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Post Breast Therapy Pain Syndrome; Lipotransplantation; Breast Cancer; Pain

Outcome Measures

Primary Outcomes (1)

• Pain in the mastectomy area

  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.

  one year

Secondary Outcomes (5)

• Collagen in the mastectomy scar

  One year

• Elastin content in the mastectomy scar

  One year

• Free nerve endings crossing between the dermis and the epidermis

  One year

• Mastectomy scar quality

  One year

• Analgesic consumption

  One year

Study Arms (2)

No active treatment

NO INTERVENTION

Clinical follow-up, no active intervention.

Lipotransplantation

EXPERIMENTAL

Lipotransplantation in general anaesthesia to the mastectomy site.

Other: Lipotransplantation

Interventions

Lipotransplantation OTHER

Lipotransplantation in general anaesthesia to the mastectomy site

Also known as: Fat grafting, Fat transplantation

Lipotransplantation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead
• University of Aarhus: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Related Publications (16)

• Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568.

  PMID: 19903919 BACKGROUND

• Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24.

  PMID: 21435953 BACKGROUND

• Carpenter JS, Andrykowski MA, Sloan P, Cunningham L, Cordova MJ, Studts JL, McGrath PC, Sloan D, Kenady DE. Postmastectomy/postlumpectomy pain in breast cancer survivors. J Clin Epidemiol. 1998 Dec;51(12):1285-92. doi: 10.1016/s0895-4356(98)00121-8.

  PMID: 10086821 BACKGROUND

• Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205. doi: 10.1016/0304-3959(96)03064-3.

  PMID: 8880841 BACKGROUND

• Lundstedt D, Gustafsson M, Steineck G, Malmstrom P, Alsadius D, Sundberg A, Wilderang U, Holmberg E, Johansson KA, Karlsson P. Risk factors of developing long-lasting breast pain after breast cancer radiotherapy. Int J Radiat Oncol Biol Phys. 2012 May 1;83(1):71-8. doi: 10.1016/j.ijrobp.2011.05.065. Epub 2011 Nov 11.

  PMID: 22079722 BACKGROUND

• Macdonald L, Bruce J, Scott NW, Smith WC, Chambers WA. Long-term follow-up of breast cancer survivors with post-mastectomy pain syndrome. Br J Cancer. 2005 Jan 31;92(2):225-30. doi: 10.1038/sj.bjc.6602304.

  PMID: 15655557 BACKGROUND

• Peuckmann V, Ekholm O, Rasmussen NK, Groenvold M, Christiansen P, Moller S, Eriksen J, Sjogren P. Chronic pain and other sequelae in long-term breast cancer survivors: nationwide survey in Denmark. Eur J Pain. 2009 May;13(5):478-85. doi: 10.1016/j.ejpain.2008.05.015. Epub 2008 Jul 16.

  PMID: 18635381 BACKGROUND

• Vilholm OJ, Cold S, Rasmussen L, Sindrup SH. The postmastectomy pain syndrome: an epidemiological study on the prevalence of chronic pain after surgery for breast cancer. Br J Cancer. 2008 Aug 19;99(4):604-10. doi: 10.1038/sj.bjc.6604534.

  PMID: 18682712 BACKGROUND

• Ducic I, Seiboth LA, Iorio ML. Chronic postoperative breast pain: danger zones for nerve injuries. Plast Reconstr Surg. 2011 Jan;127(1):41-46. doi: 10.1097/PRS.0b013e3181f9587f.

  PMID: 21200198 BACKGROUND

• Watson PNC, Evans RJ. The postmastectomy pain syndrome and topical capsaicin: a randomized trial. Pain. 1992 Dec;51(3):375-379. doi: 10.1016/0304-3959(92)90223-X.

  PMID: 1491864 BACKGROUND

• Eija K, Tiina T, J NP. Amitriptyline effectively relieves neuropathic pain following treatment of breast cancer. Pain. 1996 Feb;64(2):293-302. doi: 10.1016/0304-3959(95)00138-7.

  PMID: 8740607 BACKGROUND

• Caviggioli F, Maione L, Forcellini D, Klinger F, Klinger M. Autologous fat graft in postmastectomy pain syndrome. Plast Reconstr Surg. 2011 Aug;128(2):349-352. doi: 10.1097/PRS.0b013e31821e70e7.

  PMID: 21788826 BACKGROUND

• Coleman SR, Saboeiro AP. Fat grafting to the breast revisited: safety and efficacy. Plast Reconstr Surg. 2007 Mar;119(3):775-85; discussion 786-7. doi: 10.1097/01.prs.0000252001.59162.c9.

  PMID: 17312477 BACKGROUND

• Klinger M, Marazzi M, Vigo D, Torre M. Fat injection for cases of severe burn outcomes: a new perspective of scar remodeling and reduction. Aesthetic Plast Surg. 2008 May;32(3):465-9. doi: 10.1007/s00266-008-9122-1.

  PMID: 18305985 BACKGROUND

• Trojahn Kolle SF, Oliveri RS, Glovinski PV, Elberg JJ, Fischer-Nielsen A, Drzewiecki KT. Importance of mesenchymal stem cells in autologous fat grafting: a systematic review of existing studies. J Plast Surg Hand Surg. 2012 Apr;46(2):59-68. doi: 10.3109/2000656X.2012.668326.

  PMID: 22471250 BACKGROUND

• Kristiansen K, Lyngholm-Kjaerby P, Moe C. Introduction and Validation of DoloTest((R)): a new health-related quality of life tool used in pain patients. Pain Pract. 2010 Sep-Oct;10(5):396-403. doi: 10.1111/j.1533-2500.2010.00366.x.

  PMID: 20384966 BACKGROUND

Related Links

• The Danish Cancer Society: Incidence of breast cancer in Denmark
• The Danish Breast Cancer Group: Responsible for developing national guidelines for the treatment of breast cancer in Denmark

MeSH Terms

Conditions

Chronic Pain; Breast Neoplasms; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Alexander Juhl Andersen, M.D.

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: June 27, 2013
• Study Start: October 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: February 15, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)