Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00956670
Study type Interventional
Source Gynecologic Oncology Group
Contact
Status Active, not recruiting
Phase N/A
Start date June 2012

See also
  Status Clinical Trial Phase
Completed NCT05507346 - A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema N/A
Completed NCT06067880 - Surgical Intervention and Lymphatic Diseases.
Active, not recruiting NCT04797390 - A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema N/A
Completed NCT02676752 - Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis
Completed NCT02506530 - Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema N/A
Completed NCT06323200 - Lymphedema Duration on Lymphatic Vessel Quality and Outcomes After LVA
Completed NCT02253186 - Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema N/A
Terminated NCT02020837 - A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema Early Phase 1
Recruiting NCT01318785 - Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications Phase 2
Enrolling by invitation NCT02375165 - Biomarkers for the Detection of Lymphatic Insufficiency
Completed NCT00852930 - Low Level Laser Treatment and Breast Cancer Related Lymphedema Phase 4
Completed NCT02308488 - Study of Prone Accelerated Breast And Nodal IMRT N/A
Completed NCT01112189 - Use of Stem Cells in Lymphedema Post Mastectomy Phase 1/Phase 2
Completed NCT00743314 - Single-Photon Emission Computed Tomography, Computed Tomography Lymphoscintigraphy, and Intensity-Modulated Radiation Therapy in Treating Patients Who Have Undergone Surgery for Stage I or Stage II Breast Cancer Early Phase 1
Recruiting NCT06237907 - Pyroptosis and Ferroptosis in the Pathophysiology of Lymphedema
Terminated NCT01580800 - National Breast Cancer and Lymphedema Registry
Suspended NCT05366699 - LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy N/A
Completed NCT06249360 - Lymphatic System Reflux After Lymphatic Operation
Completed NCT06220903 - The Effect of Complex Decongestive Therapy in Patients With Lymphedema N/A
Terminated NCT02923037 - Hatha Yoga in Breast Cancer Survivors N/A