Randomized Trial of Exercise on Lower Extremity Edema After Lymphadenectomy in Gynecologic Cancer (NCT01849224) | Clinical Trial Compass
UnknownPhase 3
Randomized Trial of Exercise on Lower Extremity Edema After Lymphadenectomy in Gynecologic Cancer
South Korea148 participantsStarted 2013-05
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change in lower extremity edema-related symptoms after pelvic and lower extremities exercise