The Lymphedema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors and Impact in Newly Diagnosed Patients
Principal Investigator
Richard Barakat, MD
Status
Terminated
Date Opened To Accrual
June 04 2012
Date Closed to Accrual
November 17 2014
Date of Study Termination
April 10 2020
Disease Site
Gynecologic [GY]
Other
Phase
I
Developmental Therapeutics
No
Primary Objective
To prospectively estimate the incidence of lower extremity lymphedema in patients undergoing radical surgery with a concurrent lymphadenectomy for a gynecologic malignancy.
The first aim of this study is to prospectively determine the incidence of women who develop lymphedema following radical surgery for: a) uterine cancer; b) cervical cancer; or c) vulvar cancer.
To identify risk factors for the development of lower extremity lymphedema following radical surgery among patients with any one of the three types of gynecologic malignancy studied and to develop a corresponding predictive model.
The second aim will investigate: a) patient characteristics (i.e., age, race, body mass index (BMI), vascular insufficiency, serum albumin level, performance status, medical history, and type and stage of cancer); b) surgical characteristics (i.e., site of disease, anatomic site of nodes removed, extent of nodal dissection, blood loss, operative time, open versus minimally invasive procedure, use of closed suction drainage); and c) factors within the post-surgical period (i.e., infection, lymphocyst formation, venous thromboembolic disease, nodal status, radiation therapy, chemotherapy) to identify risk factors for the development of lymphedema in gynecologic cancer survivors. This information, along with data regarding the incidence of lymphedema obtained as part of Aim 1, will be used to create a model that predicts the likelihood and degree of risk of developing lymphedema following therapy and will ultimately allow the design of strategies for prevention.
Patient Population
Patients undergoing radical surgery with a concurrent lymphadenectomy for a gynecologic malignancy.
Target Accrual
1044
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.