Randomized Trial of Exercise on Lower Extremity Edema After Lymphadenectomy in Gynecologic Cancer
Phase 3
- Conditions
- Gynecologic Cancer
- Registration Number
- NCT01849224
- Lead Sponsor
- National Cancer Center, Korea
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 148
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in lower extremity edema-related symptoms after pelvic and lower extremities exercise 1 year after randomization
- Secondary Outcome Measures
Name Time Method the compliance rate of management guidelines for lower extremity edema, the performance rate for pelvic and lower extremity exercise 1 year after randomization
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie exercise-induced reduction of lower extremity edema in gynecologic cancer survivors post-lymphadenectomy?
How does structured pelvic/lower extremity exercise compare to standard lymphedema management protocols in gynecologic oncology?
Are there specific biomarkers that predict differential response to exercise interventions in post-lymphadenectomy lymphedema patients?
What adverse events were observed in NCT01849224 and how do they compare to conservative lymphedema therapies?
How does this exercise intervention in gynecologic cancer lymphedema align with current physical therapy guidelines for lymphatic dysfunction?
Trial Locations
- Locations (1)
Myong Cheol Lim
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Myong Cheol Lim🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic ofMyong Cheol LimPrincipal Investigator