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

Primary Purpose

Gynecologic Cancer

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pelvic and lower extremity exercise
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gynecologic Cancer focused on measuring Lower extremity edema, Lower leg lymphedema, Lower leg edema, Lymphedema, Pelvic lymphadenectomy, Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Myong Cheol LimRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pelvic and lower extremity exercise

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in lower extremity edema-related symptoms after pelvic and lower extremities exercise

Secondary Outcome Measures

the compliance rate of management guidelines for lower extremity edema, the performance rate for pelvic and lower extremity exercise

Full Information

First Posted
May 6, 2013
Last Updated
July 15, 2013
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01849224
Brief Title
Randomized Trial of Exercise on Lower Extremity Edema After Lymphadenectomy in Gynecologic Cancer
Official Title
Randomized Trial of Pelvic and Lower Extremity Exercise in Patients Who Underwent Pelvic Lymphadenectomy With Lower Extremity Edema-related Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Cancer
Keywords
Lower extremity edema, Lower leg lymphedema, Lower leg edema, Lymphedema, Pelvic lymphadenectomy, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pelvic and lower extremity exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group will be educated the guidelines for prevention and early detection of lower extremity edema
Intervention Type
Other
Intervention Name(s)
Pelvic and lower extremity exercise
Primary Outcome Measure Information:
Title
Change in lower extremity edema-related symptoms after pelvic and lower extremities exercise
Time Frame
1 year after randomization
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myong Cheol Lim, MD, PhD
Phone
+82-31-920-1760
Email
gynlim@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
JeongSeon Lee
Phone
+82-31-920-1760
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lim Myong Cheol, MD,PhD
Organizational Affiliation
National Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Myong Cheol Lim
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myong Cheol Lim
Email
gynlim@gmail.com
First Name & Middle Initial & Last Name & Degree
Myong Cheol Lim

12. IPD Sharing Statement

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

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