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

Sponsor

National Cancer Center, Korea (Other)

Overall Status

Unknown status

CT.gov ID

NCT01849224

Collaborator

(none)

148

Enrollment

Location

Arms

Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gynecologic Cancer	Other: Pelvic and lower extremity exercise	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

148 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized Trial of Pelvic and Lower Extremity Exercise in Patients Who Underwent Pelvic Lymphadenectomy With Lower Extremity Edema-related Symptoms

Study Start Date :

May 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Pelvic and lower extremity exercise
No Intervention: Control Control group will be educated the guidelines for prevention and early detection of lower extremity edema

Arm

Intervention/Treatment

Experimental: 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.

Other: Pelvic and lower extremity exercise

No Intervention: Control

Control group will be educated the guidelines for prevention and early detection of lower extremity edema

Outcome Measures

Primary Outcome Measures

Change in lower extremity edema-related symptoms after pelvic and lower extremities exercise [1 year after randomization]

Secondary Outcome Measures

the compliance rate of management guidelines for lower extremity edema, the performance rate for pelvic and lower extremity exercise [1 year after randomization]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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