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

NCT ID: NCT01849224

Last Updated: 2013-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gynecologic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pelvic and lower extremity exercise

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.

Group Type EXPERIMENTAL

Pelvic and lower extremity exercise

Intervention Type OTHER

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pelvic and lower extremity exercise

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Myong Cheol Lim

Senior researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lim Myong Cheol, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center

Locations

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Myong Cheol Lim

Goyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Myong Cheol Lim, MD, PhD

Role: CONTACT

+82-31-920-1760

JeongSeon Lee

Role: CONTACT

+82-31-920-1760

Facility Contacts

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Myong Cheol Lim

Role: primary

Other Identifiers

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NCCNCS-13-723

Identifier Type: -

Identifier Source: org_study_id

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