Breast CancerLYNCNCT02187289
Studying if Adding Night Compression to Standard Care Will Have Improved Control of Lymphedema in Breast Cancer Subjects
A study testing Night-time compression bandages, Compression Sleeve, daytime wear and Night-time Compression custom-made garment in people with Breast Cancer and Lymphedema, run by AHS Cancer Control Alberta at 3 sites in Canada.
Trial summary
Lymphedema (significant arm swelling on the surgical side) is one of the most common complications following treatment for breast cancer. The impact of lymphedema is profound, resulting in negative self image, increased anxiety and poorer quality of life. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Lymphedema
- What is being tested?
- Night-time compression bandages, Compression Sleeve, daytime wear and Night-time Compression custom-made garment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesCanada
- Study dates
- Oct 2014to Nov 2019
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histological diagnosis of breast cancer with mild to moderate lymphedema (minimum of 200 mls or 10% and maximum 40% increase in arm volume over the unaffected arm.)
- Completion of all primary and adjuvant cancer treatments (with exception of endocrine treatment) 1 month prior to randomization.
- In or entering upon the maintenance phase of lymphedema treatment.
- Have properly fitted day-time compression sleeve and agree to wear sleeve for the 12 hour per day standard of care period
- No current use of night-time compression (one month wash-out period before trial entry)
Who cannot join
- Clinical or radiological evidence of active disease, either local or metastatic
- History or clinical diagnosis of bilateral arm lymphedema
- Anyone for whom compression is contraindicated, such as those with untreated infections, skin irritations/rash, or thrombosis of the affected arm
- Serious non-malignant disease or any disorder/circumstance (psychiatric or addictive disorder) which would preclude consent/adherence to the protocol
- Unable to comply with the protocol, measurement and follow-up schedule due to factors such as vacation during the study period
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Tom Baker Cancer Centre
Calgary, Alberta
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Mount St. Joseph Hospital/Holy Family (MSJ/HF)
Vancouver, British Columbia, V5T 3N4
About this study
Official title: Night-time Compression for Breast Cancer Related Lymphedema (LYNC): A Randomized Controlled Efficacy Trial
Lymphedema (significant arm swelling on the surgical side) is one of the most common complications following treatment for breast cancer. The impact of lymphedema is profound, resulting in negative self image, increased anxiety and poorer quality of life. In time, lymphedema can result in recurrent infections in the arm, functional impairment and pain. Approximately 21% of women who undergo breast cancer treatment develop lymphedema. Unfortunately this is a life-time condition which tends to worsen over time. Currently, treatment consists of intensive physiotherapy, meant to reduce the arm volume followed by the wearing of compression sleeves during the day for maintenance. This study hopes to show that the addition of night-time compression creates a measurable reduction in arm volume and that adding night-time compression to the standard care (daytime compression only) will produce improvements in quality of life for breast cancer survivors.
Read the detailed description
Lymphedema is a lifetime condition which tends to worsen over time, affecting roughly 21% of of treated breast cancer patients. An initial intensive rehabilitative treatment is usually prescribed to reduce the lymphedema, followed by a maintenance program using compression sleeves (Standard Care). However, compression sleeves are prescribed for daytime use only due to the potential tourniquet effect of the sleeve rolling up or bunching during the night.
Compression Bandages (short stretch, low elasticity) can be used at night but proper application takes 20-30 minutes, require skill to apply properly and are costly. Various types of night-compression system garments (NCSGs) have been designed as alternatives to Compression Bandages (CB).
The objectives of this study are to determine:
- Whether the addition of night-time compression (using CB or NCSG) to standard care (daytime compression only) improves control of arm lymphedema.
- Whether the use of NCSGs result in better outcomes in quality of life, sleep, treatment compliance and patient independence than use of Compression Bandages.
The hypotheses are that:
- Standard care plus the addition of NCSG will provide statistically significant improvement in management of arm lymphedema volume compared to standard care alone at 12 weeks.
- Standard care plus the addition of Compression Bandages will provide statistically significant improved management of arm lymphedema volume compared to standard care alone at 12 weeks.
- Standard care plus the addition of NCSG will provide statistically significant benefit in quality of life, sleep and self-efficacy over standard care plus Compression Bandaging at 12 weeks.
Group 1: Standard care weeks 1 - 12 Group 2: Standard care plus night-time Compression Bandaging weeks 1 - 12 Group 3: Standard care plus night-time use of NCSG weeks 1 - 12
All three groups will adopt NCSG use after the 12 week assessments have been done (weeks 13 - 24).
Sample size = 40 participants per group, for a total of 120 patients at three sites.
Participants will be randomized in a 1:1:1 ratio to Standard, CB or NCSG using a secure central randomization service administered by the Clinical Trials Unit of the Cross Cancer Institute. Women enrolled in the study will be stratified by accruing site and by lymphedema severity (i.e. mild versus moderate lymphedema as per the classification criteria of the International Society of Lymphology).
Arm volume (by Perometer) and arm fluid (by Bioimpedance analysis) will be measured and compared to that of the unaffected arm. BIA measures the impedance of flow from a low alternating electrical current that is applied to the body through a skin electrode. BIA records impedance values for each limb and provides an index that correlates with quantitative measurements of volume increase in limb size seen in the arm with lymphedema. This measurement will provide information on extracellular fluid changes that complements the data on arm lymphedema volume. An Independent Assessor unaware of treatment allocation (blinded) will perform the measurements of arm volume using the perometer, bioimpedance analysis, and body weight at baseline, 6, 12, 18 and 24 weeks. The duration of the primary intervention will be 12 weeks. Following the 12-week intervention period, participants in the CB and standard care groups will be measured for a NCSG.
The follow-up period after the intervention (weeks 13 to 24) will follow a longitudinal observational design and provide an opportunity to examine factors related to long-term adherence to night-time compression. Lymphedema specific questionnaires and subject diary will be completed at 6, 12, 18 and 24 weeks to assess subject's Quality of Life, sleep disturbance, self-efficacy and treatment adherence.
- Conditions
- Breast Cancer, Lymphedema
- Being tested
- Night-time compression bandages, Compression Sleeve, daytime wear, Night-time Compression custom-made garment
- Keywords
- NCSG, Compression bandages, devices, Night time compression, Breast cancer treatment side effects, Compression therapy, Reid Sleeve, Comprefit, Medassist, Tribute, Comprilan
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Night-time compression bandagesDevice
Daytime compression sleeve plus night-time compression by self-administered or assisted multi-layered compression bandages.
Compression Sleeve, daytime wearDevice
Night-time Compression custom-made garmentDevice
Standard Care plus night-time compression by a custom-made night time compression system garment.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Weeks 1-12, Standard Care only (Compression Sleeve, daytime wear) Receives: Device: Compression Sleeve, daytime wear |
| Standard Care plus Night-time Compression Bandages | Experimental | Weeks 1 - 12, Daytime compression sleeve plus night-time compression by self-administered or assisted multi-layered Compression Bandages. Receives: Device: Night-time compression bandages; Device: Compression Sleeve, daytime wear |
| Standard Care Plus Night-time Compression System Garment | Experimental | Weeks 1 - 12, Standard care (day-time sleeve) plus night-time use of a custom-made Night-time Compression System Garment Receives: Device: Compression Sleeve, daytime wear; Device: Night-time Compression custom-made garment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm volume. Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany)
Measured: 12 weeks
Secondary outcomes (1)
Arm fluid. Bioimpedance analysis (BIA) will be used to assess extracellular fluid status within the arm
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2017
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Cross Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Margaret McNeely, PhD, Principal investigator, Cross Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187289
- Sponsor's protocol ID
- HREBA CC-14-0066
- Acronym
- LYNC
- Status last verified
- Feb 2021
- First submitted
- 9 Jul 2014
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be available via the University of Alberta's DATAVERSE platform.
Publications
McNeely ML, Dolgoy ND, Rafn BS, Ghosh S, Ospina PA, Al Onazi MM, Radke L, Shular M, Kuusk U, Webster M, Campbell KL, Mackey JR. Nighttime compression supports improved self-management of breast cancer-related lymphedema: A multicenter randomized controlled trial. Cancer. 2022 Feb 1;128(3):587-596. doi: 10.1002/cncr.33943. Epub 2021 Oct 6.
PubMed 34614195McNeely ML, Campbell KL, Webster M, Kuusk U, Tracey K, Mackey J. Efficacy of night-time compression for breast cancer related lymphedema (LYNC): protocol for a multi-centre, randomized controlled efficacy trial. BMC Cancer. 2016 Aug 4;16:601. doi: 10.1186/s12885-016-2648-8.
PubMed 27491361
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Night-time Compression for Breast Cancer Related Lymphedema (LYNC): A Randomized Controlled Efficacy Trial
- ClinicalTrials.gov ID
- NCT02187289
- Acronym / sponsor ID
- LYNC / HREBA CC-14-0066
- Conditions
- Breast Cancer, Lymphedema
- Keywords
- NCSG, Compression bandages, devices, Night time compression, Breast cancer treatment side effects, Compression therapy, Reid Sleeve, Comprefit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Cross Cancer Institute
- Study start
- Oct 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 11 Jul 2014 (estimated)
- 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.
Lymphedema (significant arm swelling on the surgical side) is one of the most common complications following treatment for breast cancer. The impact of lymphedema is profound, resulting in negative self image, increased anxiety and poorer quality of life. In time, lymphedema can result in recurrent infections in the arm, functional impairment and pain. Approximately 21% of women who undergo breast cancer treatment develop lymphedema. Unfortunately this is a life-time condition which tends to worsen over time. Currently, treatment consists of intensive physiotherapy, meant to reduce the arm volume followed by the wearing of compression sleeves during the day for maintenance. This study hopes to show that the addition of night-time compression creates a measurable reduction in arm volume and that adding night-time compression to the standard care (daytime compression only) will produce improvements in quality of life for breast cancer survivors.
Detailed description
Lymphedema is a lifetime condition which tends to worsen over time, affecting roughly 21% of of treated breast cancer patients. An initial intensive rehabilitative treatment is usually prescribed to reduce the lymphedema, followed by a maintenance program using compression sleeves (Standard Care). However, compression sleeves are prescribed for daytime use only due to the potential tourniquet effect of the sleeve rolling up or bunching during the night.
Compression Bandages (short stretch, low elasticity) can be used at night but proper application takes 20-30 minutes, require skill to apply properly and are costly. Various types of night-compression system garments (NCSGs) have been designed as alternatives to Compression Bandages (CB).
The objectives of this study are to determine:
- Whether the addition of night-time compression (using CB or NCSG) to standard care (daytime compression only) improves control of arm lymphedema.
- Whether the use of NCSGs result in better outcomes in quality of life, sleep, treatment compliance and patient independence than use of Compression Bandages.
The hypotheses are that:
- Standard care plus the addition of NCSG will provide statistically significant improvement in management of arm lymphedema volume compared to standard care alone at 12 weeks.
- Standard care plus the addition of Compression Bandages will provide statistically significant improved management of arm lymphedema volume compared to standard care alone at 12 weeks.
- Standard care plus the addition of NCSG will provide statistically significant benefit in quality of life, sleep and self-efficacy over standard care plus Compression Bandaging at 12 weeks.
Group 1: Standard care weeks 1 - 12 Group 2: Standard care plus night-time Compression Bandaging weeks 1 - 12 Group 3: Standard care plus night-time use of NCSG weeks 1 - 12
All three groups will adopt NCSG use after the 12 week assessments have been done (weeks 13 - 24).
Sample size = 40 participants per group, for a total of 120 patients at three sites.
Participants will be randomized in a 1:1:1 ratio to Standard, CB or NCSG using a secure central randomization service administered by the Clinical Trials Unit of the Cross Cancer Institute. Women enrolled in the study will be stratified by accruing site and by lymphedema severity (i.e. mild versus moderate lymphedema as per the classification criteria of the International Society of Lymphology).
Arm volume (by Perometer) and arm fluid (by Bioimpedance analysis) will be measured and compared to that of the unaffected arm. BIA measures the impedance of flow from a low alternating electrical current that is applied to the body through a skin electrode. BIA records impedance values for each limb and provides an index that correlates with quantitative measurements of volume increase in limb size seen in the arm with lymphedema. This measurement will provide information on extracellular fluid changes that complements the data on arm lymphedema volume. An Independent Assessor unaware of treatment allocation (blinded) will perform the measurements of arm volume using the perometer, bioimpedance analysis, and body weight at baseline, 6, 12, 18 and 24 weeks. The duration of the primary intervention will be 12 weeks. Following the 12-week intervention period, participants in the CB and standard care groups will be measured for a NCSG.
The follow-up period after the intervention (weeks 13 to 24) will follow a longitudinal observational design and provide an opportunity to examine factors related to long-term adherence to night-time compression. Lymphedema specific questionnaires and subject diary will be completed at 6, 12, 18 and 24 weeks to assess subject's Quality of Life, sleep disturbance, self-efficacy and treatment adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Device: Compression Sleeve, daytime wearWeeks 1-12, Standard Care only (Compression Sleeve, daytime wear) |
| Standard Care plus Night-time Compression Bandages | Experimental | Device: Night-time compression bandages, Device: Compression Sleeve, daytime wearWeeks 1 - 12, Daytime compression sleeve plus night-time compression by self-administered or assisted multi-layered Compression Bandages. |
| Standard Care Plus Night-time Compression System Garment | Experimental | Device: Compression Sleeve, daytime wear, Device: Night-time Compression custom-made garmentWeeks 1 - 12, Standard care (day-time sleeve) plus night-time use of a custom-made Night-time Compression System Garment |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Histological diagnosis of breast cancer with mild to moderate lymphedema (minimum of 200 mls or 10% and maximum 40% increase in arm volume over the unaffected arm.)
- Completion of all primary and adjuvant cancer treatments (with exception of endocrine treatment) 1 month prior to randomization.
- In or entering upon the maintenance phase of lymphedema treatment.
- Have properly fitted day-time compression sleeve and agree to wear sleeve for the 12 hour per day standard of care period
- No current use of night-time compression (one month wash-out period before trial entry)
Key exclusion criteria (5 listed)
- Clinical or radiological evidence of active disease, either local or metastatic
- History or clinical diagnosis of bilateral arm lymphedema
- Anyone for whom compression is contraindicated, such as those with untreated infections, skin irritations/rash, or thrombosis of the affected arm
- Serious non-malignant disease or any disorder/circumstance (psychiatric or addictive disorder) which would preclude consent/adherence to the protocol
- Unable to comply with the protocol, measurement and follow-up schedule due to factors such as vacation during the study period
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 |
|---|---|---|
| Night-time compression bandagesDaytime compression sleeve plus night-time compression by self-administered or assisted multi-layered compression bandages. | Device | Standard Care plus Night-time Compression Bandages |
| Compression Sleeve, daytime wear | Device | Standard Care Plus Night-time Compression System Garment, Standard Care plus Night-time Compression Bandages, Standard care |
| Night-time Compression custom-made garmentStandard Care plus night-time compression by a custom-made night time compression system garment. | Device | Standard Care Plus Night-time Compression System Garment |
Primary outcome
Arm volume. Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany)
Time frame: 12 weeks
1 secondary outcome
Arm fluid. Bioimpedance analysis (BIA) will be used to assess extracellular fluid status within the arm
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Derived from this study: PubMed 34614195McNeely ML, Dolgoy ND, Rafn BS, Ghosh S, Ospina PA, Al Onazi MM, Radke L, Shular M, Kuusk U, Webster M, Campbell KL, Mackey JR. Nighttime compression supports improved self-management of breast cancer-related lymphedema: A multicenter randomized controlled trial. Cancer. 2022 Feb 1;128(3):587-596. doi: 10.1002/cncr.33943. Epub 2021 Oct 6.
- Derived from this study: PubMed 27491361McNeely ML, Campbell KL, Webster M, Kuusk U, Tracey K, Mackey J. Efficacy of night-time compression for breast cancer related lymphedema (LYNC): protocol for a multi-centre, randomized controlled efficacy trial. BMC Cancer. 2016 Aug 4;16:601. doi: 10.1186/s12885-016-2648-8.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be available via the University of Alberta's DATAVERSE platform.
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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.
Margaret McNeely, PhD principal investigator
Cross Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Night-time compression bandages, Compression Sleeve, daytime wear and Night-time Compression custom-made garment in people with Breast Cancer and Lymphedema, run by AHS Cancer Control Alberta at 3 sites in Canada.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Arm volume. Lymphedema will be objectively measured using the Perometer (Pero-systems, Wipputal, Germany) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02187289, which also lists 2 linked publications.
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 21 Feb 2021.