Chronic Pain Clinical Trial
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
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus C |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital | University of Aarhus |
Denmark,
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. Review. — View Citation
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. — View Citation
Caviggioli F, Maione L, Forcellini D, Klinger F, Klinger M. Autologous fat graft in postmastectomy pain syndrome. Plast Reconstr Surg. 2011 Aug;128(2):349-52. doi: 10.1097/PRS.0b013e31821e70e7. — View Citation
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. — View Citation
Ducic I, Seiboth LA, Iorio ML. Chronic postoperative breast pain: danger zones for nerve injuries. Plast Reconstr Surg. 2011 Jan;127(1):41-6. doi: 10.1097/PRS.0b013e3181f9587f. — View Citation
Gärtner 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. Erratum in: JAMA. 2012 Nov 21;308(19):1973. — View Citation
Kalso E, Tasmuth T, Neuvonen PJ. Amitriptyline effectively relieves neuropathic pain following treatment of breast cancer. Pain. 1996 Feb;64(2):293-302. — View Citation
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. — View Citation
Kristiansen K, Lyngholm-Kjaerby P, Moe C. Introduction and Validation of DoloTest(®): 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. — View Citation
Lundstedt D, Gustafsson M, Steineck G, Malmström P, Alsadius D, Sundberg A, Wilderäng 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. — View Citation
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. — View Citation
Peuckmann V, Ekholm O, Rasmussen NK, Groenvold M, Christiansen P, Møller S, Eriksen J, Sjøgren 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. — View Citation
Trojahn Kølle 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. Review. — View Citation
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. — View Citation
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. — View Citation
Watson CP, Evans RJ. The postmastectomy pain syndrome and topical capsaicin: a randomized trial. Pain. 1992 Dec;51(3):375-9. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Collagen in the mastectomy scar | Changes in the proportions of collagen type I and III in the mastectomy scar. | One year | No |
Secondary | Elastin content in the mastectomy scar | Changes in the elastin content of the mastectomy scar. | One year | No |
Secondary | Free nerve endings crossing between the dermis and the epidermis | 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. | One year | No |
Secondary | Mastectomy scar quality | Changes in the mastectomy scar quality, measured using the Patient and Observer Scar Assessment Scale. | One year | No |
Secondary | Analgesic consumption | Changes in the analgesic consumption of the patients included in the study. | One year | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01659073 -
Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation
|
N/A | |
Recruiting |
NCT05914311 -
Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration
|
N/A | |
Recruiting |
NCT05422456 -
The Turkish Version of Functional Disability Inventory
|
||
Enrolling by invitation |
NCT05422443 -
The Turkish Version of Pain Coping Questionnaire
|
||
Completed |
NCT05057988 -
Virtual Empowered Relief for Chronic Pain
|
N/A | |
Completed |
NCT04385030 -
Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury
|
N/A | |
Recruiting |
NCT06206252 -
Can Medical Cannabis Affect Opioid Use?
|
||
Completed |
NCT05103319 -
Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
|
||
Completed |
NCT03687762 -
Back on Track to Healthy Living Study
|
N/A | |
Completed |
NCT04171336 -
Animal-assisted Therapy for Children and Adolescents With Chronic Pain
|
N/A | |
Completed |
NCT03179475 -
Targin® for Chronic Pain Management in Patients With Spinal Cord Injury
|
Phase 4 | |
Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
Completed |
NCT03268551 -
MEMO-Medical Marijuana and Opioids Study
|
||
Recruiting |
NCT06204627 -
TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain
|
N/A | |
Recruiting |
NCT06060028 -
The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain
|
N/A | |
Completed |
NCT00983385 -
Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics
|
Phase 3 | |
Recruiting |
NCT05118204 -
Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization
|
Phase 4 | |
Terminated |
NCT03538444 -
Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder
|
N/A | |
Not yet recruiting |
NCT05812703 -
Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain
|
||
Completed |
NCT05036499 -
PFI for Pain-Related Anxiety Among Hazardous Drinkers With Chronic Pain
|
N/A |