Home-based Intermittent Pneumatic Compression Therapy for Gynecologic Cancer

Not Applicable

Completed

• Conditions: Gynecologic Cancer; Lymphedema of Leg
• Interventions: Device: home-based intermittent pneumatic compression (IPC) device

• Registration Number: NCT05193357
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-07
• Primary Completion: 2019-12-03
• Study Completion: 2019-12-03
• Study First Submitted: 2021-12-27
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-11
• Last Update Submitted: 2022-01-11
• Study First Posted: 2022-01-14
• Last Update Posted: 2022-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
home-based IPC device	home-based intermittent pneumatic compression (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.

Primary Outcome Measures

Name	Time	Method
Change of Inter-limb volume difference ratio	Baseline, after 1 month (4-week)	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)

Secondary Outcome Measures

Name	Time	Method
Participant satisfaction questionnaire	after 1 month (4-week)	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).
Change of Quality of life (Lymph-ICF-LL)	Baseline, after 1 month (4-week)	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.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of