Home-based Intermittent Pneumatic Compression Therapy for Gynecologic Cancer

NCT05193357 | Completed

• 1 other identifier: homepump_study
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change of Inter-limb volume difference ratio

  Investigators measured three leg volumes: the distal leg volume (distal volume: from the smallest circumference at the ankle (B-measure) to the calf circumference right below the knee bend (D-measure)), the whole leg volume (limb volume without the foot up to the mid-thigh region (F-measure)), and the proximal leg volume (subtraction of the distal leg volume from the whole leg volume)

  Baseline, after 1 month (4-week)

Secondary Outcomes (2)

• Change of Quality of life (Lymph-ICF-LL)

  Baseline, after 1 month (4-week)

• Participant satisfaction questionnaire

  after 1 month (4-week)

Study Arms (1)

home-based IPC device

EXPERIMENTAL

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.

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

Interventions

home-based intermittent pneumatic compression (IPC) device 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.

home-based IPC device

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Ministry of Health, Republic of Korea: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 14, 2022
• Study Start: March 7, 2019
• Primary Completion: December 3, 2019
• Study Completion: December 3, 2019
• Last Updated: January 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)