LymphedemaNCT03687749
Presentation of First Time Attenders at Lymphedema Clinics
An observational study of Lymphedema and Breast Neoplasm, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in 2 countries.
Trial summary
The first aim of this research project is to identify what factors motivate patients to seek assessment for early lymphedema and further, to gain insight into the signs and symptoms of developing lymphedema and the concurrent physical measurements. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lymphedema, Breast Neoplasm
- How many people
- 46 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2017to 31 Dec 2020
- Phase
- Observational
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two hundred women who have previously been treated for unilateral breast cancer and are referred for the first time to a lymphedema clinic. These patients presenting for the first time with breast cancer-related lymphedema will be asked to have an immediate objective assessment of their lymphedema and to administer additional questionnaires and clinical tests.
Who may be able to join
- women after breast cancer (> 18 years) with unilateral axillary lymph node dissection or sentinel node biopsy; mastectomy (with or without autologous reconstruction) or wide excision of the tumor
- able to give consent to participate in the research
Who cannot join
- patients under the age of 18 years
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Australia1 site
University of Sydney, Faculty of Health Sciences
Sydney, New South Wales, 2006
About this study
Official title: Presentation of First Time Attenders at Lymphedema Clinics: Cross-sectional Study
The first aim of this research project is to identify what factors motivate patients to seek assessment for early lymphedema and further, to gain insight into the signs and symptoms of developing lymphedema and the concurrent physical measurements.
The second aim is to identify other sensory signs and symptoms and changes in body perception which may be perceived by the patient as reflective of lymphedema, and to identify to which degree they contribute to the patients' motivation to seek referral to lymphedema clinics.
Read the detailed description
One of the most challenging morbidities after breast cancer treatment is lymphedema. Approximately 20% of women treated for breast cancer with axillary lymph node dissection will be diagnosed with lymphedema. Pre- and post-operatively, women are informed about changes suggestive of lymphedema and guided about seeking further assessment. The investigators presume that if symptoms occur, patients will seek assessment. However, it is unknown whether this is true or if those prospectively monitored present earlier for treatment, or whether other factors specifically drive patients to seek further assessment. Understanding the early experience and presentation of secondary lymphedema will improve patient education and detection programs.
- Conditions
- Lymphedema, Breast Neoplasm
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with breast cancer-related lymphedema | Individuals with upper limb lymphedema developed after breast cancer treatment | |
| Healthy control subjects | Healthy individuals without breast cancer-related lymphoedema. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extracellular fluid in the arm
Bioimpedance spectroscopy (BIS) is a measurement tool used to determine the volume of extracellular fluid, of which lymph fluid is a component.
Measured: immediately after inclusion in the study
Arm volume
Arm circumference measures are commonly used to diagnose and monitor lymphedema.
Measured: immediately after inclusion in the study
Pitting
The pitting tests examines the responsiveness of tissue to pressure and can be used to help determine the stage of lymphedema.
Measured: immediately after inclusion in the study
Secondary outcomes (9)
Self-reported signs and symptoms of lymphedema
Norman questionnaire for early detection of lymphedema will be used; this validated questionnaire will allow us to determine the location and severity of the symptoms that the patients have experienced over the past three months as well as how much distress it has caused.
Measured: immediately after inclusion in the study
Impairments in function, activity limitations, and participation restrictions of patients with arm lymphedema
Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF): The Lymph-ICF is a reliable and valid questionnaire to assess impairments in function, activity limitations, and participation restrictions of patients with arm lymphedema.
Measured: immediately after inclusion in the study
Global Health Status/Quality of Life Score
Health-related quality of life assessed with the generic QLQ-C30 and the disease-specific QLQ-BR23 questionnaire
Measured: immediately after inclusion in the study
Body perception
The BATH CRPS body perception disturbances scale: to assess body perception disturbances in breast cancer patients.
Measured: immediately after inclusion in the study
Pain intensity assessed with the Numeric Rating Scale
Numeric Rating Scale for maximal pain intensity during the past week.
Measured: immediately after inclusion in the study
Prevalence of neuropathic pain
Measured with the Douleur Neuropathique en 4 questions (DN4)
Measured: immediately after inclusion in the study
Tactile acuity (Two-point discrimination)
To assess body perception two-point discrimination will be assessed at both arms, the breasts and lateral trunk side.
Measured: immediately after inclusion in the study
Mechanical detection and pain threshold
The lowest mechanical forces, applied to the skin using nylon monofilaments that the subject can 1) detect and 2) is perceived as painful) are tested at the upper limb and upper body region.
Measured: immediately after inclusion in the study
Temporal summation
Detection of perceived temporal summation at the upper limb and upper body region tested using repeated 26g nylon monofilament stimulation.
Measured: immediately after inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start1 Feb 2017
- Primary completion1 Feb 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney
- Responsible party
- Sponsor
- Investigators
- An De Groef, PhD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenElizabeth Dylke, PhD, Principal investigator, University of Sydney, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687749
- Sponsor's protocol ID
- S59883
- Status last verified
- Apr 2021
- First submitted
- 10 Jul 2018
- Last updated
- 30 Apr 2021
- 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 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presentation of First Time Attenders at Lymphedema Clinics: Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03687749
- Acronym / sponsor ID
- S59883
- Conditions
- Lymphedema, Breast Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- University of Sydney
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 27 Sep 2018 (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.
The first aim of this research project is to identify what factors motivate patients to seek assessment for early lymphedema and further, to gain insight into the signs and symptoms of developing lymphedema and the concurrent physical measurements.
The second aim is to identify other sensory signs and symptoms and changes in body perception which may be perceived by the patient as reflective of lymphedema, and to identify to which degree they contribute to the patients' motivation to seek referral to lymphedema clinics.
Detailed description
One of the most challenging morbidities after breast cancer treatment is lymphedema. Approximately 20% of women treated for breast cancer with axillary lymph node dissection will be diagnosed with lymphedema. Pre- and post-operatively, women are informed about changes suggestive of lymphedema and guided about seeking further assessment. The investigators presume that if symptoms occur, patients will seek assessment. However, it is unknown whether this is true or if those prospectively monitored present earlier for treatment, or whether other factors specifically drive patients to seek further assessment. Understanding the early experience and presentation of secondary lymphedema will improve patient education and detection programs.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with breast cancer-related lymphedema | – | –Individuals with upper limb lymphedema developed after breast cancer treatment |
| Healthy control subjects | – | –Healthy individuals without breast cancer-related lymphoedema. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two hundred women who have previously been treated for unilateral breast cancer and are referred for the first time to a lymphedema clinic. These patients presenting for the first time with breast cancer-related lymphedema will be asked to have an immediate objective assessment of their lymphedema and to administer additional questionnaires and clinical tests.
Key inclusion criteria (2 listed)
- women after breast cancer (> 18 years) with unilateral axillary lymph node dissection or sentinel node biopsy; mastectomy (with or without autologous reconstruction) or wide excision of the tumor
- able to give consent to participate in the research
Key exclusion criteria (1 listed)
- patients under the age of 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Extracellular fluid in the arm
Time frame: immediately after inclusion in the study
Bioimpedance spectroscopy (BIS) is a measurement tool used to determine the volume of extracellular fluid, of which lymph fluid is a component.
Arm volume
Time frame: immediately after inclusion in the study
Arm circumference measures are commonly used to diagnose and monitor lymphedema.
Pitting
Time frame: immediately after inclusion in the study
The pitting tests examines the responsiveness of tissue to pressure and can be used to help determine the stage of lymphedema.
9 secondary outcomes
Self-reported signs and symptoms of lymphedema
Time frame: immediately after inclusion in the study
Impairments in function, activity limitations, and participation restrictions of patients with arm lymphedema
Time frame: immediately after inclusion in the study
Global Health Status/Quality of Life Score
Time frame: immediately after inclusion in the study
Body perception
Time frame: immediately after inclusion in the study
Pain intensity assessed with the Numeric Rating Scale
Time frame: immediately after inclusion in the study
Prevalence of neuropathic pain
Time frame: immediately after inclusion in the study
Tactile acuity (Two-point discrimination)
Time frame: immediately after inclusion in the study
Mechanical detection and pain threshold
Time frame: immediately after inclusion in the study
Temporal summation
Time frame: immediately after inclusion in the study
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 30 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Lymphedema
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
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.
An De Groef, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
Elizabeth Dylke, PhD principal investigator
University of Sydney, Faculty of Health Sciences
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema and Breast Neoplasm, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in 2 countries.
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 2 inclusion and 1 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 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Belgium. 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?
Extracellular fluid in the arm (time frame: immediately after inclusion in the study). The study lists 3 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 30 Apr 2021.