Breast CancerPROTECTNCT04522648
Prospective Surveillance for Breast Cancer-Related Lymphedema
A study testing Prospective surveillance in people with Breast Cancer, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
Trial summary
This randomized trial will test the effect of a prospective surveillance program for early detection and subclinical management of breast cancer-related lymphedema on the prevalence of chronic lymphedema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Prospective surveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesDenmark
- Study dates
- 4 Jan 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- female;
- ≥18 years;
- surgery for breast cancer (unilateral and bilateral) including ALDN with >6 lymph nodes removed;
- can effectively communicate verbally in Danish;
Who cannot join
- surgery for breast cancer with SLNB or < 6 nodes removed;
- pre-existing lymphedema (primary or secondary);
- previous treatment for breast cancer;
- pace maker;
- conditions known to cause swelling (pregnancy, congestive heart failure, chronic/acute renal disease, cor pulmonale, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, and thrombophlebitis or deep vein thrombosis in the arms).
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Copenhagen University Hospital Rigshospitalet
Copenhagen, 2100
Herlev Hospital
Herlev
Odense University Hospital
Odense
About this study
Official title: Prospective Surveillance for Breast Cancer-Related Lymphedema: A Randomized Trial
This randomized trial will test the effect of a prospective surveillance program for early detection and subclinical management of breast cancer-related lymphedema on the prevalence of chronic lymphedema.
Read the detailed description
Design and setting: This trial is a multi-center single-blind trial involving five hospitals in Denmark.
Procedure: All women booked for surgery for breast cancer at one of the study sites will be invited to participate. Women, who provide written informed consent, will have BIS measurements, and perform self-measurements of arm circumference. Further, participants will complete a sociodemographic questionnaire which will be used to ensure recruitment of a representable sample. This data will be collected at the hospital of surgery at pre-treatment. After surgery, women who had >6 lymph nodes removed and have planned radiation therapy will be randomized 1:1 into intervention or control.
- Conditions
- Breast Cancer
- Being tested
- Prospective surveillance
- Keywords
- lymphedema, Prospective surveillance
- 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.
Prospective surveillanceOther
A participant with an increase from pre-surgery in total arm volume of ≥6% by self-measurement, or symptoms of BCRL ≥2 NRS will receive an assessment by a lymphedema therapist. At this appointment, participants will receive a physical examination of the arm along with a BIS measurement. A participant is considered having subclinical BCRL if an increase in lymphedema index (L-DEX) ≥7 from pre-surgery measured by BIS is identified. A fitted compression garment and gauntlet is then provided, free of charge, for daily wear 10 hours/day for four weeks along with a recommendation to use the arm for daily activities and maintain regular physical activity. Following the four-week compression period, participants will be re-measured using BIS to evaluate response. Participants who do not respond to compression will receive CDT delivered by the lymphedema therapist.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (INT) | Experimental | INT participants will be asked to perform self-measurements of arm circumference at five points along the arm at home every three months. Additional measurements can be performed if the participants experience signs of BCRL. Participants will report the self-measurements in cm and mm in an online questionnaire, or over the phone to a physiotherapist navigator, along with reporting sign and symptoms of BCRL. Receives: Other: Prospective surveillance |
| Control (CON) | No intervention | The CON group will follow the usual post-operative care. CON participants will be prompted every 6 months by an online questionnaire to report if they have been diagnosed with BCRL and if so, month of initiation of treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of chronic lymphedema
A binary outcome (y/n) defined as BIS ≥10 from pre-surgery or outside normal range ±10
Measured: At 24 months post-surgery
Secondary outcomes (3)
Time-to-treatment
INT group: The time (weeks) from surgery to first elevated L-DEX score which triggers immediate treatment along with time (weeks) to resolution of BCRL from diagnosis. For CON: time from surgery to BCRL diagnosis, time from diagnosis to BCRL treatment, and time from initiation to termination of treatment
Measured: INT group: will be collected throughtout the study period. CON group: at 6, 12, 18 and 24 months post-surgery
Health-related quality of life
This will be measured by the EQ-5D questionnaire
Measured: pre-treatment, 6, 12, 18 and 24 months post-surgery
Arm function
This will be measured by the QuickDASH questionnaire
Measured: pre-treatment, 6, 12, 18 and 24 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start4 Jan 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital, Zealand University Hospital, Herlev Hospital
- Responsible party
- Principal investigator, Bolette Rafn, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522648
- Sponsor's protocol ID
- PROTECT
- Acronym
- PROTECT
- Status last verified
- May 2026
- First submitted
- 18 Aug 2020
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Surveillance for Breast Cancer-Related Lymphedema: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04522648
- Acronym / sponsor ID
- PROTECT / PROTECT
- Conditions
- Breast Cancer
- Keywords
- lymphedema, Prospective surveillance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital, Zealand University Hospital, Herlev Hospital
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Aug 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 randomized trial will test the effect of a prospective surveillance program for early detection and subclinical management of breast cancer-related lymphedema on the prevalence of chronic lymphedema.
Detailed description
Design and setting: This trial is a multi-center single-blind trial involving five hospitals in Denmark.
Procedure: All women booked for surgery for breast cancer at one of the study sites will be invited to participate. Women, who provide written informed consent, will have BIS measurements, and perform self-measurements of arm circumference. Further, participants will complete a sociodemographic questionnaire which will be used to ensure recruitment of a representable sample. This data will be collected at the hospital of surgery at pre-treatment. After surgery, women who had >6 lymph nodes removed and have planned radiation therapy will be randomized 1:1 into intervention or control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (INT) | Experimental | Other: Prospective surveillanceINT participants will be asked to perform self-measurements of arm circumference at five points along the arm at home every three months. Additional measurements can be performed if the participants experience signs of BCRL. Participants will report the self-measurements in cm and mm in an online questionnaire, or over the phone to a physiotherapist navigator, along with reporting sign and symptoms of BCRL. |
| Control (CON) | No intervention | –The CON group will follow the usual post-operative care. CON participants will be prompted every 6 months by an online questionnaire to report if they have been diagnosed with BCRL and if so, month of initiation of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- female;
- ≥18 years;
- surgery for breast cancer (unilateral and bilateral) including ALDN with >6 lymph nodes removed;
- can effectively communicate verbally in Danish;
Key exclusion criteria (5 listed)
- surgery for breast cancer with SLNB or < 6 nodes removed;
- pre-existing lymphedema (primary or secondary);
- previous treatment for breast cancer;
- pace maker;
- conditions known to cause swelling (pregnancy, congestive heart failure, chronic/acute renal disease, cor pulmonale, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, and thrombophlebitis or deep vein thrombosis in the arms).
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 |
|---|---|---|
| Prospective surveillanceA participant with an increase from pre-surgery in total arm volume of ≥6% by self-measurement, or symptoms of BCRL ≥2 NRS will receive an assessment by a lymphedema therapist. At this appointment, participants will receive a physical examination of the arm along with a BIS measurement. A participant is considered having subclinical BCRL if an increase in lymphedema index (L-DEX) ≥7 from pre-surgery measured by BIS is identified. A fitted compression garment and gauntlet is then provided, free of charge, for daily wear 10 hours/day for four weeks along with a recommendation to use the arm for daily activities and maintain regular physical activity. Following the four-week compression period, participants will be re-measured using BIS to evaluate response. Participants who do not respond to compression will receive CDT delivered by the lymphedema therapist. | Other | Intervention (INT) |
Primary outcome
Prevalence of chronic lymphedema
Time frame: At 24 months post-surgery
A binary outcome (y/n) defined as BIS ≥10 from pre-surgery or outside normal range ±10
3 secondary outcomes
Time-to-treatment
Time frame: INT group: will be collected throughtout the study period. CON group: at 6, 12, 18 and 24 months post-surgery
Health-related quality of life
Time frame: pre-treatment, 6, 12, 18 and 24 months post-surgery
Arm function
Time frame: pre-treatment, 6, 12, 18 and 24 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prospective surveillance in people with Breast Cancer, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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?
Prevalence of chronic lymphedema (time frame: At 24 months post-surgery). 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 22 May 2026.