Lymphedema Clinical Trial
Official title:
The LymphEdema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and Impact in Newly Diagnosed Patients
This clinical trial studies lymphedema after surgery in patients with endometrial cancer, cervical cancer, or vulvar cancer. Collecting information over time about how often lymphedema occurs in patients undergoing surgery and lymphadenectomy for endometrial cancer, cervical cancer, and vulvar cancer may help doctors learn more about the disease and plan the best treatment.
PRIMARY OBJECTIVES:
I. To prospectively estimate the incidence of lower extremity lymphedema in patients
undergoing radical surgery with a concurrent lymphadenectomy with a concurrent
lymphadenectomy for a gynecologic malignancy.
II. 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.
SECONDARY OBJECTIVES:
I. To identify the effect that lower extremity lymphedema has on quality of life (QOL) (as
measured with Functional Assessment of Cancer Therapy - General [FACT-G] + disease specific
subscale), psychological adjustment (as measured with Impact of Events Scale [IES] and
Functional Assessment of Chronic Illness Therapy [FACIT] body image items) and physical
disability (of lower extremity as measured with Lower Extremity Functional Scale [LEFS]) and
physical function(as measured by FACT-Functional Wellbeing [FW] subscale, FACIT disease
specific items & patient-reported outcomes measurement information system [PROMIS] items)
and to investigate potential protective mechanisms (FACT-Social Wellbeing [SW] subscale and
patient characteristics).
II. To explore if patient self-reported symptoms (as measured with the lymphedema [LE]
Symptom Measure [Cancer Lymphedema Questionnaire (GCLQ)]) are associated with the
development of lymphedema in patients undergoing radical surgery for gynecologic malignancy.
TERTIARY OBJECTIVES:
I. To explore the effect of moderate or severe lymphedema (primary endpoint) on QOL
outcomes, as measured by the FACT-General (G) questionnaire.
OUTLINE:
Patients with vulvar cancer undergo a radical vulvectomy or hemi-vulvectomy followed
immediately by an ipsilateral or bilateral inguinal-femoral lymphadenectomy. (Closed to
accrual as of June 9, 2014)
Patients with cervical cancer undergo a radical hysterectomy or trachelectomy and bilateral
pelvic lymphadenectomy +/- para-aortic nodal sampling via vaginal, laparoscopic, or open
route.
Patients with endometrial cancer undergo a laparoscopic-assisted vaginal hysterectomy, a
total laparoscopic hysterectomy, or total abdominal hysterectomy with pelvic lymphadenectomy
+/- para-aortic node sampling.
Patients undergo limb measurements at baseline, weeks 4-6, and at 3, 6, 9, 12, 18, and 24
months.
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