Randomized Trial of Exercise on Lower Extremity Edema After Lymphadenectomy in Gynecologic Cancer

Phase 3

• Conditions: Gynecologic Cancer
• Interventions: Other: Pelvic and lower extremity exercise

• Registration Number: NCT01849224
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

The primary outcome is the change in lower extremity edema-related symptoms. Secondary outcomes include the compliance rate of management guidelines for lower extremity edema, the performance rate for pelvic and lower extremity exercise.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-06
• Study First Submitted QC: 2013-05-06
• Study First Posted: 2013-05-08
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-15
• Last Update Posted: 2013-07-16
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 148

Inclusion Criteria

• More than 18 years of age
• Patients who underwent pelvic lymphadenectomy
• Patients with suspicious pelvic cancer who finished active treatments such as chemotherapy, radiotherapy or surgery. The interval between the time of randomization and the end of the treatment should be more than 2 weeks.
• The patient is able to understand the study and is willing to give written informed consent to the study
• patient with edema-related symptoms such as leg heaviness, distension, tightness, pain, limited movement, or weakness etc.

Exclusion Criteria

• Severe systemic diseases causing peripheral edema, including renal disease
• Severe or uncontrolled cardiopulmonary disease, including implantable device such as a pacemaker
• Acute superficial or deep vein thrombosis
• Previous major surgery for lower extremities, including metallic surgical implant
• Local infection in the lower extremities
• Auto-immunological disorders or vasculitis
• Use of systemic corticosteroids
• Pregnant or currently breastfeeding
• Alcohol or drug abuse
• Uncontrolled diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelvic and lower extremity exercise	Pelvic and lower extremity exercise	Experimental arm will be educated the guidelines for prevention and early detection of lower extremity edema. Additionally, pelvic and lower extremity exercise will be educated and participants will continue exercise for 1 year at home.

Primary Outcome Measures

Name	Time	Method
Change in lower extremity edema-related symptoms after pelvic and lower extremities exercise	1 year after randomization

Secondary Outcome Measures

Name	Time	Method
the compliance rate of management guidelines for lower extremity edema, the performance rate for pelvic and lower extremity exercise	1 year after randomization

Trial Locations

Locations (1)

Myong Cheol Lim; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of