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


Phase 3
18 Years
N/A
Not Enrolling
Female
Gynecologic Cancer

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Trial Information

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


Inclusion Criteria:



- More than 18 years of age

- Patients who underwent pelvic lymph node dissection

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

1 year after randomization

Safety Issue:

No

Principal Investigator

Lim Myong Cheol, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center

Authority:

Korea: Institutional Review Board

Study ID:

NCCNCS-13-723

NCT ID:

NCT01849224

Start Date:

May 2013

Completion Date:

December 2015

Related Keywords:

  • Gynecologic Cancer
  • Lower extremity edema
  • Lower leg lymphedema
  • Lower leg edema
  • Lymphdema
  • Pelvic lymph node dissection
  • Exercise
  • Edema

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