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

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01849224
• Other study ID #: NCCNCS-13-723
• Status: Recruiting
• Phase: Phase 3
• First received: May 6, 2013
• Last updated: July 15, 2013
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: July 2013
• Source: National Cancer Center, Korea
• Contact: Myong Cheol Lim, MD, PhD
• Phone: +82-31-920-1760
• Email: gynlim[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

Other:
• Pelvic and lower extremity exercise

Locations

Country	Name	City	State
Korea, Republic of	Myong Cheol Lim	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in lower extremity edema-related symptoms after pelvic and lower extremities exercise		1 year after randomization	No
Secondary	the compliance rate of management guidelines for lower extremity edema, the performance rate for pelvic and lower extremity exercise		1 year after randomization	No