Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment

Breast Cancer Clinical Trial

Official title:

Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01273909
• Other study ID #: MFM001
• Secondary ID: 1116697
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 7, 2011
• Last updated: June 4, 2014
• Start date: July 2010
• Est. completion date: January 2016

Study information

• Verified date: June 2014
• Source: The National Institute of Lymphology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The goal of this prospective, observational study is to investigate the clinical, psychosocial, and patient satisfaction outcomes of patients who undergo perforator flap reconstruction for breast reconstruction and/or vascularized lymph node transfer (VLNTx) for the treatment of lymphedema.

The investigators hypothesize that (1) perforator flap breast reconstruction will result in excellent clinical, psychosocial, and patient satisfaction outcomes compared to non-perforator flap breast reconstruction; (2) perforator flap breast reconstruction is associated with less persistent postsurgical pain than other forms of breast reconstruction, even after controlling for major cofactors, such as the extent of auxiliary lymph node dissection and the use of radiation therapy; (3) perforator flap reconstruction for the treatment of Lymphedema (i.e., VLNTx ) will result in the reduction of symptoms and complications of lymphedema.

Description:

Breast cancer is a serious health issue that affects 1 in 8 women. Although numerous treatments have arisen in recent years to aggressively combat this disease and increase survivorship, many survivors develop a crippling condition that can result in devastating physical and psychological impairments. Breast reconstruction by any method may help recovery psychologically. However, some individuals still report experiencing pain following their recovery from surgery. Additionally, secondary lymphedema is a common yet poorly understood complication of breast cancer patients. For those individuals who undergo axillary lymph node dissection the rates of incidence of lymphedema approach 47%. These rates tend to increase further for patients who receive irradiation treatment or mastectomies. Currently there is no known cure for lymphedema. Current treatments include non-invasive measures as well as surgical interventions. Vascularized lymph node transfer (VLNTx) is a fairly recent surgical procedure that has shown promising results.

The goal of this research study is to analyze the clinical outcome of subjects who undergo breast reconstruction with perforator flaps and/or VLNTx using information collected as part of standard care.

Clinical data will be collected prospectively. All subjects who undergo a surgical procedure will complete the online persistent postsurgical pain assessment questionnaire.

The BreastQ questionnaire will be completed by patients prior to and after undergoing breast reconstruction and/or lymphedema treatment.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Undergoing perforator flap surgery for breast reconstruction and/or vascularized lymph node transfer for treatment of lymphedema

Exclusion Criteria:

• Pregnant

• unable to read

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Lymphedema
• Breast Cancer
• Congenital Lymphedema
• Hereditary Breast/Ovarian Cancer (brca1, brca2)
• Lymphedema

Intervention

Procedure:
• Perforator Flap Breast Reconstruction
perforator flap breast reconstruction with or without vascularized lymph node transfer
• Vascularized Lymph Node Transfer
perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction

Locations

Country	Name	City	State
United States	The DrMarga Practice Group	Charleston	South Carolina
United States	National Institute of Lymphology	Chicago	Illinois
United States	The Center for Restorative Breast Surgery	New Orleans	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
The National Institute of Lymphology	The Center for Restorative Breast Surgery, LLC, The DrMarga Practice Group

Country where clinical trial is conducted

United States, 

References & Publications (5)

Becker C, Assouad J, Riquet M, Hidden G. Postmastectomy lymphedema: long-term results following microsurgical lymph node transplantation. Ann Surg. 2006 Mar;243(3):313-5. — View Citation

Dayangac M, Makay O, Yeniay L, Aynaci M, Kapkac M, Yilmaz R. Precipitating factors for lymphedema following surgical treatment of breast cancer: implications for patients undergoing axillary lymph node dissection. Breast J. 2009 Mar-Apr;15(2):210-1. doi: 10.1111/j.1524-4741.2009.00703.x. — 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

Massey MF, Spiegel AJ, Levine JL, Craigie JE, Kline RM, Khoobehi K, Erhard H, Greenspun DT, Allen RJ Jr, Allen RJ Sr; Group for the Advancement of Breast Reconstruction. Perforator flaps: recent experience, current trends, and future directions based on 3974 microsurgical breast reconstructions. Plast Reconstr Surg. 2009 Sep;124(3):737-51. doi: 10.1097/PRS.0b013e3181b17a56. — View Citation

Rockson SG, Rivera KK. Estimating the population burden of lymphedema. Ann N Y Acad Sci. 2008;1131:147-54. doi: 10.1196/annals.1413.014. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BreastQ Questionnaire and Lymphedema Severity Score		Baseline and 6 months after surgery	Yes
Secondary	Persistent Postsurgical Pain assessment questionnaire		6 months after surgery	Yes

External Links

•   National Institute of Lymphology research web page