Trials / Unknown

UnknownNCT00956670

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

The LymphEdema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and Impact in Newly Diagnosed Patients

Status: Unknown
Phase: N/A
Study type: Interventional
Enrollment: 1,055 (actual)

Sponsor: Gynecologic Oncology Group · Network
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Study of High Risk Factors	Undergo lymphedema assessment
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgery
PROCEDURE	Therapeutic Laparoscopic Surgery	Undergo surgery
PROCEDURE	Therapeutic Lymphadenectomy	Undergo lymphadenectomy

Timeline

Start date: 2012-06-01
Primary completion: 2015-04-01
First posted: 2009-08-11
Last updated: 2017-05-08

Locations

213 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00956670. Inclusion in this directory is not an endorsement.