Clinical trial NCT04435639: Using an Adjustable Compression Garment for Secondary Upper Limb Lymphoedema
Official title: Can an Adjustable Compression Garment Replace Compression Bandaging in the Treatment of Patients With Breast Cancer Related Upper Limb Lymphoedema? A Pilot RCT Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Lymphedema of Upper Arm
Keywords: Breast cancer related lymphoedema.
Compression bandaging.
Lead sponsor: Institute of Technology, Sligo
Sponsor class: OTHER
Collaborators: name: Sligo General Hospital
First posted: 2020-06-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot Randomised Controlled Trial
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Limb Volume - Circumferential Measurements.
timeFrame: Over a 6 month period. (10 min testing time)
measure: Short Form 36 (SF-36): Quality of Life questionnaire.
timeFrame: Over a 6 month period. (10 min testing time)
Secondary outcomes:
Other outcomes:
Locations:
city: Sligo
country: Ireland
facility: Atlantic Technological University
Study officials:
affiliation: Study Principal Investigator
name: Shane Gallagher, MSc
role: PRINCIPAL_INVESTIGATOR
References: