Home-based Intermittent Pneumatic Compression Therapy for Gynecologic Cancer

Home-based Intermittent Pneumatic Compression Therapy: the Impact in Chronic Leg Lymphedema in Patients Treated for Gynecologic Cancer

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer; Lymphedema of Leg
• Intervention / Treatment: Device: home-based intermittent pneumatic compression (IPC) device

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Quality of life (Lymph-ICF-LL)	Lymphedema Functioning, Disability, and Health Questionnaire for Lower Limb Lymphedema (Lymph-ICF-LL). Questionnaire contains 28 questions divided into 5 domains: physical function, mental function, general tasks/household activities, mobility activities, and life domains/social life. Each question is scored from 0 (not at all) to 10 (a lot), with lower scores representing better QOL. The total scores and 5 domain scores were calculated by summation.	Baseline, after 1 month (4-week)
Participant satisfaction questionnaire	The questionnaire contained 6 items related to the subjective effects of the IPC device related to volume reduction, pain, heaviness, skin hardness, ease of use, and overall satisfaction with the home therapy offered by the device. Each question was answered using a 5-point scale from 1 (not at all) to 5 (very much).	after 1 month (4-week)

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Ministry of Health, Republic of Korea

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 7, 2019
• Primary Completion (ACTUAL): December 3, 2019
• Study Completion (ACTUAL): December 3, 2019

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (ACTUAL): January 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: homepump_study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No