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

NCT01849224 | Unknown Phase 3 DMC

• 1 other identifier: NCCNCS-13-723
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer

Keywords

Lower extremity edema; Lower leg lymphedema; Lower leg edema; Lymphedema; Pelvic lymphadenectomy; Exercise

Outcome Measures

Primary Outcomes (1)

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

  1 year after randomization

Secondary Outcomes (1)

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

  1 year after randomization

Study Arms (2)

Pelvic and lower extremity exercise

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Pelvic and lower extremity exercise OTHER

Pelvic and lower extremity exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

Myong Cheol Lim

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

RECRUITING

MeSH Terms

Conditions

Lymphedema; Motor Activity

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Behavior

Study Officials

• Lim Myong Cheol, MD,PhD

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Myong Cheol Lim, MD, PhD

CONTACT

+82-31-920-1760; gynlim@gmail.com

JeongSeon Lee

CONTACT

+82-31-920-1760

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 8, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 16, 2013

Record last verified: 2013-07

Locations

KR (1)