Clinical Trials

1 studies in Cervical Cancer

1. Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer Scottsdale and Phoenix, AZ Rochester, MN View Summary
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   Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer

   Location:

   Scottsdale and Phoenix, AZ Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   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.

   NCT ID:

   NCT00956670

   IRB Number:

   12-007809

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