Using an Adjustable Compression Garment for Secondary Upper Limb Lymphoedema

Can an Adjustable Compression Garment Replace Compression Bandaging in the Treatment of Patients With Breast Cancer Related Upper Limb Lymphoedema? A Pilot RCT Study

This is a pilot randomised controlled trial investigating the use of an adjustable compression garment in the treatment of patients with Breast Cancer related upper limb Lymphoedema. This study will be conducted as part of a MSc qualification at the Institute of Technology Sligo in Ireland with all therapy sessions taking place in the Physiotherapy Department of Sligo University Hospital (formerly Sligo General Hospital). The study will be conducted in conjunction with Sligo University Hospital and it has attained ethical approval through the relevant University Hospital Ethics Committee.

Study Overview

• Status: Unknown
• Conditions: Lymphedema of Upper Arm
• Intervention / Treatment: Other: Manual lymph drainage.; Device: Adjustable Compression Sleeve; Procedure: Coban compression bandage..

Detailed Description

The experimental group will receive 5 treatments followed by a final assessment on the 6th visit over a 3 week period: participants will receive manual lymphatic drainage for 40 minutes. They will then put on an Adjustable Compression sleeve (Juzo varocare adjustable compression system). Patients will be re-measured before the fourth treatment and again on session 6. At this point patients will receive a standard arm compression sleeve. This will be worn in alternation with their adjustable compression sleeve over the following 6 months. Patient will have their limb volume re-measured at the 6 month review.

The control group will receive 5 treatments followed by a final assessment on the 6th visit over a 3 week period: participants will receive manual lymphatic drainage for 40 minutes. They will then have their arm wrapped in Coban compression bandaging which will stay on until their next treatment. This will occur twice weekly for a period of 3 weeks. Patients will be Re-measured before the fourth treatment and again on session 6. At this point they will attend occupational therapy where they will receive 2 standard arm compression sleeves. The patient wears 1 sleeve every day over the following 6 months. Patient will have their limb volume re-measured at the 6 month review.

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

Contacts and Locations

• Study Contact: Name: Kenneth Monaghan, PhD; Phone Number: 0879480448; Email: monaghan.kenneth@itsligo.ie
• Study Contact Backup: Name: Shane Gallagher, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Upper limb lymphoedema (secondary to breast cancer) diagnosed by a consultant
• Aged > 18 years.
• Males and females.
• Stage 2 Lymphoedema.
• >10% volume difference between upper limbs.
• Cognitive ability to understand the programme.

Exclusion Criteria:

• Involvement in other studies or rehabilitation programmes.
• Active infection disease progression.
• Congestive Cardiac Failure.
• Non-English speakers.
• Under 18's.
• Poor cognition for treatment compliance or consent.
• Pregnant, or currently breast feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MLD + Adjustable Compression Sleeve.; Manual lymph drainage + Adjustable Compression Sleeve.	Other: Manual lymph drainage.; Manual Lymphatic drainage: Patients will receive manual lymphatic drainage by massage for 40 minutes for 5 treatments over a 15 day period.; Device: Adjustable Compression Sleeve; Patients wear an adjustable compression sleeve (Juzo varocare adjustable compression system) between treatments. They will be shown how to put it on and how to tighten the sleeve when needed. Patients will also wear the adjustable compression sleeve in alternation with a standard compression sleeve over a six month maintenance phase.
Active Comparator: MLD + Coban Compression Bandage.; Manual lymphatic drainage + Coban compression bandaging.	Other: Manual lymph drainage.; Manual Lymphatic drainage: Patients will receive manual lymphatic drainage by massage for 40 minutes for 5 treatments over a 15 day period.; Procedure: Coban compression bandage..; Coban compression bandaging: Patients will be wrapped in Coban compression bandaging which stays on until the next treatment. Patients will wear standard compression sleeves during the six month maintenance phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Limb Volume - Circumferential Measurements.	Limb Volume- circumferential measurements taken at 4cm intervals from the wrist up to the axilla. The circumferences were then entered into a spreadsheet and a truncated cone formula applied with each segment volume calculated: Vs = h(Ct x Ct + Ct x Cb x Cb) 12 π where (Vs) was volume of a segment, (h) was the distance between two points of measurement, (Ct) represented the circumference at the top measurements of the segment, (Cb) represented the circumference at the base of the segment, π = Pi. Once each segment is calculated, the sum of all segments of the arm are computed into a volume estimate. This method was found to be valid (criterion validity)in several studies when compared to the gold standard of water displacement with intra-class correlation coefficient (ICC) of >0.95. The higher the score the more lymphoedema present.	Over a 6 month period. (10 min testing time)
Short Form 36 (SF-36): Quality of Life questionnaire.	SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting for routine monitoring and assessment of care outcomes in adult patients.It is scored 0-100 with a lower score indicating more disability.	Over a 6 month period. (10 min testing time)

Collaborators and Investigators

• Sponsor: Institute of Technology, Sligo
• Collaborators: Sligo General Hospital
• Investigators: Principal Investigator: Shane Gallagher, MSc, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Anticipated): October 30, 2020
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 7, 2020
• Last Update Submitted That Met QC Criteria: August 5, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Breast cancer related lymphoedema.; Compression bandaging.
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: ITSligo SG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No