Status:

UNKNOWN

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

Lead Sponsor:

National Cancer Center, Korea

Conditions:

Gynecologic Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE3

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2015

Estimated Enrollment :

148 Patients enrolled

Trial Details

Trial ID

NCT01849224

Start Date

May 1 2013

End Date

December 1 2015

Last Update

July 16 2013

Active Locations (1)

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1

Myong Cheol Lim

Goyang-si, Gyeonggi-do, South Korea, 410-769