Home-based Intermittent Pneumatic Compression Therapy for Gynecologic Cancer
Primary Purpose
Gynecologic Cancer, Lymphedema of Leg
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
home-based intermittent pneumatic compression (IPC) device
Sponsored by
About this trial
This is an interventional treatment trial for Gynecologic Cancer
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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
home-based IPC device
Arm 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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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).
Full Information
NCT ID
NCT05193357
First Posted
December 27, 2021
Last Updated
January 11, 2022
Sponsor
Samsung Medical Center
Collaborators
Ministry of Health, Republic of Korea
1. Study Identification
Unique Protocol Identification Number
NCT05193357
Brief Title
Home-based Intermittent Pneumatic Compression Therapy for Gynecologic Cancer
Official Title
Home-based Intermittent Pneumatic Compression Therapy: the Impact in Chronic Leg Lymphedema in Patients Treated for Gynecologic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 7, 2019 (Actual)
Primary Completion Date
December 3, 2019 (Actual)
Study Completion Date
December 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Ministry of Health, Republic of Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Cancer, Lymphedema of Leg
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
home-based IPC device
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
home-based intermittent pneumatic compression (IPC) device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Inter-limb volume difference ratio
Description
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)
Time Frame
Baseline, after 1 month (4-week)
Secondary Outcome Measure Information:
Title
Change of Quality of life (Lymph-ICF-LL)
Description
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.
Time Frame
Baseline, after 1 month (4-week)
Title
Participant satisfaction questionnaire
Description
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).
Time Frame
after 1 month (4-week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Home-based Intermittent Pneumatic Compression Therapy for Gynecologic Cancer
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