Home-based Intermittent Pneumatic Compression Therapy for Gynecologic Cancer

NCT ID: NCT05193357

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-07
• Study Completion Date: 2019-12-03

Brief Summary

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.

Conditions

Gynecologic Cancer; Lymphedema of Leg

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

home-based IPC device

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.

Group Type: EXPERIMENTAL

home-based intermittent pneumatic compression (IPC) device

Intervention Type: DEVICE

During the intervention, two programmed modes were used. The first mode, which mimics the MLD massage technique, begins with the inflation of the proximal chamber. After reaching the target pressure, the next chamber consecutively inflates while the initially inflated proximal chamber deflates. The inflation time of each chamber is 3 seconds with holding time of 1 second. The deflation and resting time of each chamber is 7 seconds (pressure setting: 40-60 mmHg). After 30 minutes of the first mode, the second mode, which is the conventional mode of sequential inflation from distal to proximal chambers while sustaining the pressure of the previously inflated chambers, was applied for 30 minutes (pressure setting: 80-100 mmHg, inflation time of each chamber: 6 seconds, holding time: 1 second, deflation time of each chamber: 7 seconds). Participants were instructed to use the IPC device with that 1-hour cycle twice a day for four weeks.

Interventions

home-based intermittent pneumatic compression (IPC) device

During the intervention, two programmed modes were used. The first mode, which mimics the MLD massage technique, begins with the inflation of the proximal chamber. After reaching the target pressure, the next chamber consecutively inflates while the initially inflated proximal chamber deflates. The inflation time of each chamber is 3 seconds with holding time of 1 second. The deflation and resting time of each chamber is 7 seconds (pressure setting: 40-60 mmHg). After 30 minutes of the first mode, the second mode, which is the conventional mode of sequential inflation from distal to proximal chambers while sustaining the pressure of the previously inflated chambers, was applied for 30 minutes (pressure setting: 80-100 mmHg, inflation time of each chamber: 6 seconds, holding time: 1 second, deflation time of each chamber: 7 seconds). Participants were instructed to use the IPC device with that 1-hour cycle twice a day for four weeks.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Republic of Korea

OTHER_GOV

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

JiHye Hwang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

homepump_study

Identifier Type: -

Identifier Source: org_study_id