Home-based Intermittent Pneumatic Compression Therapy for Gynecologic Cancer

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05193357
• Other study ID #: homepump_study
• Status: Completed
• Phase: N/A
• Start date: March 7, 2019
• Est. completion date: December 3, 2019

Study information

• Verified date: January 2022
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 3, 2019
• Est. primary completion date: December 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Cancer
• Lymphedema
• Lymphedema of Leg

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Ministry of Health, Republic of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)