Lymphedema of Upper ArmNCT06009666
Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema
An observational study of Lymphedema of Upper Arm and Stiffness of Hand, Not Elsewhere Classified, run by Marmara University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the feasibility of shear-wave elastography for the diagnosis and staging of breast cancer related lymphedema by assessing the skin and subcutaneous tissues of the arm and forearm, which could serve as a reference standard and be more easily applicable in daily life; and to… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lymphedema of Upper Arm, Stiffness of Hand, Not Elsewhere Classified, Evaluations, Diagnostic Self
- What is being tested?
- Shear Wave Elastography and B Mode Ultrasonography, Quick Dash Questionnare and The Lymphedema Life Impact Scale
- Type of treatment
- Injection or infusion
- How many people
- 72 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 1 Nov 2022
- 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 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: In our study, individuals with breast cancer-related lymphedema diagnosis followed by Marmara University Pendik Training and Research Hospital Physical Medicine and Rehabilitation Department were included in the patient group, while upper extremity data of healthy volunteers without a known lymphedema history were controlled by one-to-one matching, considering the dominant and lymphedema sides of the patient group. included in the group.
Who may be able to join
- For the patient group
- between the ages of 18-75
- diagnosed with breast cancer-associated lymphedema by lymphoscintigraphy
- being stage 0-1-2 lymphedema according to ISL staging For the control group
- between the ages of 18-75
- no history of breast cancer
Who cannot join
- History of surgery in the assessment area
- History of trauma at the assessment site
- Active infection in the assessment area
- Presence of congenital or acquired malformations at the assessment site
- Primary lymphedema
- those with any medical condition that may cause edema, such as advanced heart or kidney failure
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Canan Şanal-Toprak
Istanbul, 34899
Marmara University School of Medicine, Pendik Education and Research Hospital, Department of Physical Medicine and Rehabilitation
Istanbul
About this study
Official title: Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema and Investigation of the Relationship of These Parameters With Clinical Data
The aim of this study is to evaluate the feasibility of shear-wave elastography for the diagnosis and staging of breast cancer related lymphedema by assessing the skin and subcutaneous tissues of the arm and forearm, which could serve as a reference standard and be more easily applicable in daily life; and to investigate the relationship between the patients' symptoms and elastographic measurements.
Read the detailed description
Both upper extremities of 72 patients with lymphedema and 72 healthy upper extremities were included in the study. The patients' demographic and clinical data were recorded. The thickness and echogenicity of the skin and subcutaneous tissues of all extremities were evaluated with B-mode ultrasonography, and the stiffness of the skin and subcutaneous tissues was evaluated with shear-wave elastography. The lymphedema arm and the healthy arm of the patients were compared both with each other and with the data of the control group. Interobserver and intraobserver reliability analysis was performed for ultrasonography and elastography measurements. The patients' pain, tension, weight, and stiffness symptoms associated with lymphedema were questioned using a numerical scale. The patients' functionality and participation in daily life activities were evaluated with the Quick DASH and Life Impact Index questionnaires. The relationship between these findings and elastographic and ultrasonographic parameters was analyzed.
- Conditions
- Lymphedema of Upper Arm, Stiffness of Hand, Not Elsewhere Classified, Evaluations, Diagnostic Self
- Being tested
- Shear Wave Elastography and B Mode Ultrasonography, Quick Dash Questionnare, The Lymphedema Life Impact Scale, Questioning lymphedema-related symptoms, Extremity circumference and volume measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear Wave Elastography and B Mode UltrasonographyDiagnostic test
We evaluated the both upper extremities of the patient and control group with elastography and B mode ultrasonography. Shear wave elastography evaluates tissue deformation caused by acoustic radiation force. A highly focused ultrasound radiation is produced; The propagation speed of the shear wave depends on the stiffness of the tissue. It is a simple, inexpensive, bedside, widely available, non-invasive technique. B mode USG can be used to assess skin and subcutaneous tissue thickness and echogenicity. Skin and subcutaneous thickness were measured with b mode ultrasound. Skin and subcutaneous tissue stiffness was measured by shear wave ultrasonography
Quick Dash QuestionnareDiagnostic test
Quick-DASH is an assessment questionnaire that measures activity and participation limitations in all upper extremity disorders. In the questionnaire, the difficulties of the patients during their daily living activities are questioned with 11 questions. Each answer is scored from 1 to 5 on a Likert scale, from best to worst.
The Lymphedema Life Impact ScaleDiagnostic test
The Lymphedema Life Impact Scale is a questionnaire developed to evaluate the physical, functional and psychosocial effects of lymphedema. It consists of 18 questions; It includes 8 physical, 4 psychosocial and 6 functional subgroups. Each question is scored from 1 to 5, with higher scores indicating increased seriousness.
Questioning lymphedema-related symptomsDiagnostic test
Arm pain and feeling of tension, heaviness and stiffness in the arm were evaluated separately by numerical scale. This scale is a 10 cm ruler that writes no pain, no tension, no heaviness, no stiffness on one side, and unbearable pain, tension and heaviness on the other side. Patients were asked to rate their associated symptoms on this scale between 0 and 10.
Extremity circumference and volume measurementOther
For the diagnosis of lymphedema, a detailed physical examination and extremity circumference were measured. This measurement was taken from both wrists to arm height with 4 cm intervals. Those with a circumference difference greater than 2 cm and/or no 10% volume difference were considered preclinical (latent) and those with clinical lymphedema.
| Study group | Role | What they receive |
|---|---|---|
| Patient Group | Both Extremities of Patients With Breast Cancer Related Lymphedema Receives: Diagnostic Test: Shear Wave Elastography and B Mode Ultrasonography; Diagnostic Test: Quick Dash Questionnare; Diagnostic Test: The Lymphedema Life Impact Scale; Diagnostic Test: Questioning lymphedema-related symptoms; Other: Extremity circumference and volume measurement | |
| Control Group | Both Extremities of Healthy People With No History of Breast Cancer Receives: Diagnostic Test: Shear Wave Elastography and B Mode Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
B Mode Ultrasonography Measurements
Arm and forearm skin and subcutaneous tissue thicknesses in milimetres evaluated by B mode USG
Measured: Day 0
Shear Wave Elastography Measurements
Arm and forearm skin and subcutaneous tissue stiffness in kilopascal evaluated by Shear wave elastography
Measured: Day 0
B Mode Ultrasonography Measurements
Arm and forearm skin and subcutaneous tissue SEG and SEFS grades evaluated in echogenicity grade system by B mode USG
Measured: Day 0
Secondary outcomes (4)
Association of USG and SWE Measurements With Symptoms
It is the relationship between the parameters evaluated by USG ( thickness in milimetres echogenity according to grading system) and SWE (stiffness in kilopascal) and the pain, tension, heaviness and stiffness scoring in which symptoms in numeric scale.
Measured: Day 0
Association of USG and SWE Measurements With Functionality
It is the relationship between the parameters evaluated by USG (thickhickness in milimetres , echogenity according to grading system) and SWE (stiffness in kilopascal) and QUİCK DASH Questionnaire Score
Measured: Day 0
Association of USG and SWE Measurements With Participation İn Daily Life
It is the relationship between the parameters evaluated by USG (thickness in milimetres ,echogenity according to grading system) and SWE (stiffness in kilopascal) and The Life İmpact Questionnaire Scale
Measured: Day 0
Association of USG and SWE Measurements With Volume Measurements
It is the volume measurement of both arms of the patients in cubic centimetre.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Feb 2022
- Primary completion1 Apr 2022
- Study completion1 Nov 2022
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.
- More trials run by Marmara UniversityThe 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CANAN ŞANAL TOPRAK, Study chair, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009666
- Sponsor's protocol ID
- 07.01.2022.145
- Status last verified
- Aug 2023
- First submitted
- 3 Feb 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema and Investigation of the Relationship of These Parameters With Clinical Data
- ClinicalTrials.gov ID
- NCT06009666
- Acronym / sponsor ID
- 07.01.2022.145
- Conditions
- Lymphedema of Upper Arm, Stiffness of Hand, Not Elsewhere Classified, Evaluations, Diagnostic Self
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 24 Aug 2023 (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 aim of this study is to evaluate the feasibility of shear-wave elastography for the diagnosis and staging of breast cancer related lymphedema by assessing the skin and subcutaneous tissues of the arm and forearm, which could serve as a reference standard and be more easily applicable in daily life; and to investigate the relationship between the patients' symptoms and elastographic measurements.
Detailed description
Both upper extremities of 72 patients with lymphedema and 72 healthy upper extremities were included in the study. The patients' demographic and clinical data were recorded. The thickness and echogenicity of the skin and subcutaneous tissues of all extremities were evaluated with B-mode ultrasonography, and the stiffness of the skin and subcutaneous tissues was evaluated with shear-wave elastography. The lymphedema arm and the healthy arm of the patients were compared both with each other and with the data of the control group. Interobserver and intraobserver reliability analysis was performed for ultrasonography and elastography measurements. The patients' pain, tension, weight, and stiffness symptoms associated with lymphedema were questioned using a numerical scale. The patients' functionality and participation in daily life activities were evaluated with the Quick DASH and Life Impact Index questionnaires. The relationship between these findings and elastographic and ultrasonographic parameters was analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Group | – | Diagnostic Test: Shear Wave Elastography and B Mode Ultrasonography, Diagnostic Test: Quick Dash Questionnare, Diagnostic Test: The Lymphedema Life Impact Scale, Diagnostic Test: Questioning lymphedema-related symptoms, Other: Extremity circumference and volume measurementBoth Extremities of Patients With Breast Cancer Related Lymphedema |
| Control Group | – | Diagnostic Test: Shear Wave Elastography and B Mode UltrasonographyBoth Extremities of Healthy People With No History of Breast Cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In our study, individuals with breast cancer-related lymphedema diagnosis followed by Marmara University Pendik Training and Research Hospital Physical Medicine and Rehabilitation Department were included in the patient group, while upper extremity data of healthy volunteers without a known lymphedema history were controlled by one-to-one matching, considering the dominant and lymphedema sides of the patient group. included in the group.
Key inclusion criteria (6 listed)
- For the patient group
- between the ages of 18-75
- diagnosed with breast cancer-associated lymphedema by lymphoscintigraphy
- being stage 0-1-2 lymphedema according to ISL staging For the control group
- between the ages of 18-75
Key exclusion criteria (6 listed)
- History of surgery in the assessment area
- History of trauma at the assessment site
- Active infection in the assessment area
- Presence of congenital or acquired malformations at the assessment site
- Primary lymphedema
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 |
|---|---|---|
| Shear Wave Elastography and B Mode UltrasonographyWe evaluated the both upper extremities of the patient and control group with elastography and B mode ultrasonography. Shear wave elastography evaluates tissue deformation caused by acoustic radiation force. A highly focused ultrasound radiation is produced; The propagation speed of the shear wave depends on the stiffness of the tissue. It is a simple, inexpensive, bedside, widely available, non-invasive technique. B mode USG can be used to assess skin and subcutaneous tissue thickness and echogenicity. Skin and subcutaneous thickness were measured with b mode ultrasound. Skin and subcutaneous tissue stiffness was measured by shear wave ultrasonography | Diagnostic test | Control Group, Patient Group |
| Quick Dash QuestionnareQuick-DASH is an assessment questionnaire that measures activity and participation limitations in all upper extremity disorders. In the questionnaire, the difficulties of the patients during their daily living activities are questioned with 11 questions. Each answer is scored from 1 to 5 on a Likert scale, from best to worst. | Diagnostic test | Patient Group |
| The Lymphedema Life Impact ScaleThe Lymphedema Life Impact Scale is a questionnaire developed to evaluate the physical, functional and psychosocial effects of lymphedema. It consists of 18 questions; It includes 8 physical, 4 psychosocial and 6 functional subgroups. Each question is scored from 1 to 5, with higher scores indicating increased seriousness. | Diagnostic test | Patient Group |
| Questioning lymphedema-related symptomsArm pain and feeling of tension, heaviness and stiffness in the arm were evaluated separately by numerical scale. This scale is a 10 cm ruler that writes no pain, no tension, no heaviness, no stiffness on one side, and unbearable pain, tension and heaviness on the other side. Patients were asked to rate their associated symptoms on this scale between 0 and 10. | Diagnostic test | Patient Group |
| Extremity circumference and volume measurementFor the diagnosis of lymphedema, a detailed physical examination and extremity circumference were measured. This measurement was taken from both wrists to arm height with 4 cm intervals. Those with a circumference difference greater than 2 cm and/or no 10% volume difference were considered preclinical (latent) and those with clinical lymphedema. | Other | Patient Group |
Primary outcome
B Mode Ultrasonography Measurements
Time frame: Day 0
Arm and forearm skin and subcutaneous tissue thicknesses in milimetres evaluated by B mode USG
Shear Wave Elastography Measurements
Time frame: Day 0
Arm and forearm skin and subcutaneous tissue stiffness in kilopascal evaluated by Shear wave elastography
B Mode Ultrasonography Measurements
Time frame: Day 0
Arm and forearm skin and subcutaneous tissue SEG and SEFS grades evaluated in echogenicity grade system by B mode USG
4 secondary outcomes
Association of USG and SWE Measurements With Symptoms
Time frame: Day 0
Association of USG and SWE Measurements With Functionality
Time frame: Day 0
Association of USG and SWE Measurements With Participation İn Daily Life
Time frame: Day 0
Association of USG and SWE Measurements With Volume Measurements
Time frame: Day 0
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 24 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
CANAN ŞANAL TOPRAK study chair
Marmara University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema of Upper Arm and Stiffness of Hand, Not Elsewhere Classified, run by Marmara University at 2 sites in Turkey (Türkiye).
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 6 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 24 Aug 2023. 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 Turkey (Türkiye). 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?
B Mode Ultrasonography Measurements (time frame: Day 0). 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 24 Aug 2023.