Clinical trial NCT01273909: Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment
Official title: Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Hereditary Breast/Ovarian Cancer (brca1, brca2)
Acquired Lymphedema
Congenital Lymphedema
Keywords: Breast Cancer
BRACA1/2 Genotype
Acquired Lymphedema
Congenital Lymphedema
Lead sponsor: The National Institute of Lymphology
Sponsor class: INDUSTRY
Collaborators: name: The DrMarga Practice Group
name: The Center for Restorative Breast Surgery, LLC
First posted: 2011-01-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects who are patients of the "Dr Marga" Practice or the Center for Restorative Breast Surgery that consent to participate in this research study will be selected. There is no age, ethnicity or gender requirement.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in BreastQ Questionnaire and Lymphedema Severity Score
timeFrame: Baseline and 6 months after surgery
Secondary outcomes:
measure: Persistent Postsurgical Pain assessment questionnaire
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: National Institute of Lymphology
state: Illinois
city: New Orleans
country: United States
facility: The Center for Restorative Breast Surgery
state: Louisiana
city: Charleston
country: United States
facility: The DrMarga Practice Group
state: South Carolina
Study officials:
affiliation: National Institute of Lymphology
name: Marga F. Massey, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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):737-751. doi: 10.1097/PRS.0b013e3181b17a56.
citation: 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.
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. No abstract available.
citation: 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. doi: 10.1097/01.sla.0000201258.10304.16.
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.