Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer

• Incidence of lymphedema [ Designated as safety issue: No ]
  
• Quality of life as assessed by the FACT-G, FACT-Cx, FACT-V, Impact of Event Scale (IES), Lymphedema Symptoms Assessment, and Lymphadenopathy Assessment questionnaires [ Designated as safety issue: No ]
  

• Patient characteristics: age, height, weight, body mass index, performance status, race [ Designated as safety issue: No ]
  
• Surgical characteristics: number of lymph nodes removed, laterality of nodes removed (bilateral vs. unilateral), lymph node status (presence/absence of metastases) [ Designated as safety issue: No ]
  
• Post-surgical characteristics: development of infection, type of closed suction drain used, lymphocyst formation, use of radiation, and use of chemotherapy [ Designated as safety issue: No ]
  
• Frequency and severity of adverse events as assessed by CTCAE v3.0 [ Designated as safety issue: Yes ]
  

OBJECTIVES:

Primary

• To prospectively estimate the incidence of lower extremity lymphedema in patients undergoing radical surgery with a concurrent lymphadenectomy for endometrial (uterine), cervical, or vulvar cancer.
• To identify risk factors for the development of lower extremity lymphedema following radical surgery and to develop a corresponding predictive model.

Secondary

• To identify the effect that lower extremity lymphedema has on quality of life (QOL) of these patients, as assessed by Functional Assessment of Cancer Therapy/Impact of Events Scale [FACT- IES].
• To explore if patient self-reported symptoms are associated with the development of lymphedema.
• To explore the effect of moderate or severe lymphedema on QOL outcomes, as measured by the FACT-G questionnaire.

OUTLINE: This is a multicenter study.

Patients with vulvar cancer undergo a radical vulvectomy or hemi-vulvectomy followed immediately by an ipsilateral or bilateral inguinal-femoral lymphadenectomy. 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. Psychosocial variables and quality of life is assessed periodically by the FACT-G, FACT-Cx, FACT-V, Impact of Event Scale (IES), Lymphedema Symptoms Assessment, and Lymphadenopathy Assessment questionnaires. Patients also complete a self-reported symptom questionnaire.

PROJECTED ACCRUAL: A total of 500 patients with endometrial cancer, 500 with cervical cancer, and 300 with vulvar cancer will be accrued for this study.