Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer
Recruitment status was Not yet recruiting
RATIONALE: 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.
PURPOSE: This clinical trial is studying lymphedema after surgery in patients with endometrial cancer, cervical cancer, or vulvar cancer.
Other: questionnaire administration
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
Procedure: study of high risk factors
Procedure: therapeutic conventional surgery
Procedure: therapeutic laparoscopic surgery
Procedure: therapeutic lymphadenectomy
|Study Design:||Primary Purpose: Supportive Care|
|Official Title:||The Lymphedema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and Impact|
- 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 ]
|Study Start Date:||October 2009|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|Study Chair:||Richard R. Barakat, MD||Memorial Sloan-Kettering Cancer Center|