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

July 15, 2013 updated by: Myong Cheol Lim, National Cancer Center, Korea

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

148

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in lower extremity edema-related symptoms after pelvic and lower extremities exercise
Time Frame: 1 year after randomization
1 year after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
the compliance rate of management guidelines for lower extremity edema, the performance rate for pelvic and lower extremity exercise
Time Frame: 1 year after randomization
1 year after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Lim Myong Cheol, MD,PhD, National Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 6, 2013

First Submitted That Met QC Criteria

May 6, 2013

First Posted (Estimate)

May 8, 2013

Study Record Updates

Last Update Posted (Estimate)

July 16, 2013

Last Update Submitted That Met QC Criteria

July 15, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCNCS-13-723

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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