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

National Cancer Center (NCC)

Status and phase: Unknown; Phase 3

Conditions: Gynecologic Cancer

Treatments: Other: Pelvic and lower extremity exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01849224

NCCNCS-13-723

Details and patient eligibility

About

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.

Enrollment: 148 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Pelvic and lower extremity exercise

Experimental group

Description:

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.

Treatment:

Other: Pelvic and lower extremity exercise

Control

No Intervention group

Description:

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