Home-based Intermittent Pneumatic Compression Therapy for Gynecologic Cancer

Samsung Medical Center

Status: Completed

Conditions: Gynecologic Cancer; Lymphedema of Leg

Treatments: Device: home-based intermittent pneumatic compression (IPC) device

Study type: Interventional

Funder types: Other

Identifiers

NCT05193357

homepump_study

Details and patient eligibility

About

Investigators conducted a prospective study of cancer patients to investigate the efficacy, quality of life, satisfaction, and safety of a home-based intermittent pneumatic compression (IPC) device during the maintenance phase of lower extremity lymphedema. This device has a unique mode designed to mimic the manual lymphatic drainage (MLD) technique and thereby gently facilitate lymphatic draining of proximal extremities.

Enrollment: 30 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• stage 3 chronic unilateral secondary leg lymphedema
• aged 20-70 years
• underwent 1-2 cycle of treatment of decongestive phase with current inter-limb volume difference of more than 10%
• stable limb-volume change (within 10%) during the preceding 3 months
• capacity for self-maintenance care for lymphedema (multilayer limb bandaging, compression garments, and MLD)

Exclusion criteria

• bilateral leg lymphedema
• current cancer metastasis
• ongoing chemotherapy or radiation therapy
• acute inflammation
• venous thrombosis, or chronic venous insufficiency
• systemic etiologies of edema
• congestive heart failure
• patients taking medication that influenced body fluid or electrolytes

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

home-based IPC device

Experimental group

Description:

Participants used a device produced by Maxstar Corp. (Gimpo, South Korea), which specializes in pneumatic compression appliance manufacture. The IPC device (UAM-9306NB) was cleared by National Institute of Medical Device Safety Information (NIDS) of Korea (approval number: 18-4745). This device consists of a six-chamber pneumatic sleeve and a gradient-sequential pneumatic pump.

Treatment:

Device: home-based intermittent pneumatic compression (IPC) device