Lymphedema of Upper ArmNCT04435639
Using an Adjustable Compression Garment for Secondary Upper Limb Lymphoedema
A study testing Manual lymph drainage., Coban compression bandage.. and Adjustable Compression Sleeve in people with Lymphedema of Upper Arm, run by Institute of Technology, Sligo at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema of Upper Arm
- What is being tested?
- Manual lymph drainage., Coban compression bandage.. and Adjustable Compression Sleeve
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- 30 Oct 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Lymphedema of Upper Arm
- Being tested
- Manual lymph drainage., Coban compression bandage.., Adjustable Compression Sleeve
- Keywords
- Breast cancer related lymphoedema., Compression bandaging.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual lymph drainage.Other
Manual Lymphatic drainage:
Patients will receive manual lymphatic drainage by massage for 40 minutes for 5 treatments over a 15 day period.
Coban compression bandage..Procedure or surgery
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.
Adjustable Compression SleeveDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MLD + Adjustable Compression Sleeve. | Experimental | Manual lymph drainage + Adjustable Compression Sleeve. Receives: Other: Manual lymph drainage.; Device: Adjustable Compression Sleeve |
| MLD + Coban Compression Bandage. | Active comparator | Manual lymphatic drainage + Coban compression bandaging. Receives: Other: Manual lymph drainage.; Procedure: Coban compression bandage.. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Over a 6 month period. (10 min testing time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start30 Oct 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Why it stopped: Researcher unable to continue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema of Upper ArmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot Randomised Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Technology, Sligo
- Sponsor type
- University, hospital or other
- Collaborators
- Sligo General Hospital
- Responsible party
- Sponsor
- Investigators
- Shane Gallagher, MSc, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435639
- Sponsor's protocol ID
- ITSligo SG
- Status last verified
- Oct 2024
- First submitted
- 15 Jun 2020
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04435639
- Acronym / sponsor ID
- ITSligo SG
- Conditions
- Lymphedema of Upper Arm
- Keywords
- Breast cancer related lymphoedema., Compression bandaging.
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Researcher unable to continue.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute of Technology, SligoUniversity, hospital or other
- Collaborators
- Sligo General Hospital
- Study start
- 30 Oct 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| MLD + Adjustable Compression Sleeve. | Experimental | Other: Manual lymph drainage., Device: Adjustable Compression SleeveManual lymph drainage + Adjustable Compression Sleeve. |
| MLD + Coban Compression Bandage. | Active comparator | Other: Manual lymph drainage., Procedure: Coban compression bandage..Manual lymphatic drainage + Coban compression bandaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- Involvement in other studies or rehabilitation programmes.
- Active infection disease progression.
- Congestive Cardiac Failure.
- Non-English speakers.
- Under 18's.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | MLD + Adjustable Compression Sleeve., MLD + Coban Compression Bandage. |
| 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. | Procedure or surgery | MLD + Coban Compression Bandage. |
| Adjustable Compression SleevePatients 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. | Device | MLD + Adjustable Compression Sleeve. |
Primary outcome
Limb Volume - Circumferential Measurements.
Time frame: Over a 6 month period. (10 min testing time)
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.
Short Form 36 (SF-36): Quality of Life questionnaire.
Time frame: Over a 6 month period. (10 min testing time)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shane Gallagher, MSc principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual lymph drainage., Coban compression bandage.. and Adjustable Compression Sleeve in people with Lymphedema of Upper Arm, run by Institute of Technology, Sligo at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limb Volume - Circumferential Measurements. (time frame: Over a 6 month period. (10 min testing time)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.