Lymphedema of Upper ArmNCT04213001
Diagnostic Contribution of Ultrasonography in Breast Cancer-Related Lymphedema
A study testing ultrasonographic measurement in people with Lymphedema of Upper Arm, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Breast cancer is the most common cancer in women. It is an important health problem that has been increasingly encountered in recent years. With advances in treatment, the survival time after breast cancer is prolonged, and as a result, many women face certain diseases during this period. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Lymphedema of Upper Arm
- What is being tested?
- ultrasonographic measurement
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2020to 31 Jan 2020
- 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 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be diagnosed with breast cancer-related unilateral lymphedema
- Being over 18 years old
- Having a female gender
Who cannot join
- Bilateral breast cancer
- Existing upper extremity infection
- Lymphangitis
- Refusal to participate in the study
- Presence of edema in lower extremity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz eylul university
Izmir, Inciralti, 35340
About this study
Breast cancer is the most common cancer in women. It is an important health problem that has been increasingly encountered in recent years. With advances in treatment, the survival time after breast cancer is prolonged, and as a result, many women face certain diseases during this period. One of these diseases, breast cancer-related lymphedema, is characterized by abnormal accumulation of protein-rich fluid in the interstitial tissue, which can occur at any time after breast cancer surgery or radiotherapy and is a major cause of morbidity.Early and accurate diagnosis of lymphedema is very important for effective treatment. In routine clinical practice there are various methods used to diagnose lymphedema such as history, physical examination and limb circumference. Circumferential measurement is based on the principle of circumference measurement at certain intervals (such as 4 cm, 5 cm, 10 cm) from certain anatomical reference points on the extremities. Volume calculation can also be made from a data obtained from circumferential measurements via a computer program. Circumferential and volume measurements are used in the diagnosis, severity of lymphedema and follow-up of treatment. Although it is the most commonly used method in practice, circumferential measurements and volume measurements alone can ignore changes in tissue structure and significant changes in the presence of latent lymphedema. At the same time, circumferential measurements are made at regular intervals and the difference between the healthy side and 2 cm or more is considered as lymphedema, which may neglect tissue and edema changes in areas not in the measuring area. Ultrasonography, which has been used in the measurement and evaluation of lymphedema in recent years, is a noninvasive economic method. Skin and subcutaneous distance in lymphedema can be measured by ultrasonography, and changes in tissue structure, fibrous tissue, adipose tissue and muscle tissue can be demonstrated. Fibrotic changes in lymphedema tissue play a key role in progression. Subcutaneous ultrasound echogenicity (SEG), which is thought to be a measure of lymphedema severity in extremities, was determined as stages 0, 1 and 2. According to this; Stage 0: No increase in echogenicity in the subcutaneous layer. That is, the subcutaneous fat layer is observed as black. Stage 1: Diffuse increase in echogenicity, but identifiable horizontal or oblique-focused echogenic lines caused by bundles of connective tissue may be seen. In this study, the investigators aimed to determine the correlation between circumferential measurements and skin and subcutaneous tissue ultrasonography in breast cancer-related lymphedema patients.The primer aim of this study is to investigate the correlation between circumferential measurements and ultrasonographic measurements in breast cancer-related lymphedema. The secondary aim is to investigate the relationship among the changes in subcutaneous tissue structure (subcutaneous ultrasound echogenicity degree-SEG) and lymphedema severity in breast cancer-related lymphedema.
Read the detailed description
Patients with unilateral breast cancer-related lymphedema will be included in the study. The circumferences will be measured with a measuring tape from wrist ulnar styloid to axilla at 4 cm intervals. The point where the difference between the upper extremities was highest and the control point with no difference in the lower extremities will be marked. Ultrasonographic skin and subcutaneous thickness measurements will be performed from 4 quadrants; volar medial-lateral and dorsal medial-lateral sides of the extremity, with the probe placed transverse and perpendicular to the skin at the marked points.
The severity of lymphedema was graded ultrasonographically according to the SEG scale. (Stage 0: No increase in echogenicity in the subcutaneous layer. That is, subcutaneous fat is observed as black. Stage 1: Diffuse increase in echogenicity, but identifiable horizontal or oblique-oriented echogenic lines caused by bundles of connective tissue can be seen. Stage 2: A widespread increase in echogenicity echogenic lines cannot be identified.) Spearman test was used for correlations and Receiver Operating Characteristics (ROC) curve analysis was used to estimate the diagnostic accuracy. Sensitivity and specificity were calculated using a statistically significant threshold. Differences between ultrasonographic measurements between control points in lower extremities were compared with Wilcoxon test.
The minimum number of patients to be included in the study, according to the G-Power program, effect size d = 0.5, alpha-α = 0.05 and power 0.80 was calculated to be at least 34.
- Conditions
- Lymphedema of Upper Arm
- Being tested
- ultrasonographic measurement
- Keywords
- Lymphedema, Circumferential measurements, ultrasonography
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographic measurementDiagnostic test
ultrasonographic measurement- Subcutaneous ultrasound echogenicity (SEG) and Skin and subcutaneous thickness measurement
| Study group | Role | What they receive |
|---|---|---|
| measure | Other | circumference measure, ultrasonographic measure Receives: Diagnostic Test: ultrasonographic measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasonographic measurement
- Subcutaneous ultrasound echogenicity (SEG) and Skin and subcutaneous thickness measurement
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start2 Jan 2020
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Banu Dilek, Dokuz Eylul University
- Investigators
- Banu Dilek, Study director, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213001
- Sponsor's protocol ID
- DokuzEUBanuNihan
- Status last verified
- May 2020
- First submitted
- 24 Dec 2019
- Last updated
- 21 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erdinc Gunduz N, Dilek B, Sahin E, Ellidokuz H, Akalin E. Diagnostic Contribution of Ultrasonography in Breast Cancer-Related Lymphedema. Lymphat Res Biol. 2021 Dec;19(6):517-523. doi: 10.1089/lrb.2020.0068. Epub 2021 Feb 18.
PubMed 33601960
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Contribution of Ultrasonography in Breast Cancer-Related Lymphedema
- ClinicalTrials.gov ID
- NCT04213001
- Acronym / sponsor ID
- DokuzEUBanuNihan
- Conditions
- Lymphedema of Upper Arm
- Keywords
- Lymphedema, Circumferential measurements, ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 30 Dec 2019 (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.
Breast cancer is the most common cancer in women. It is an important health problem that has been increasingly encountered in recent years. With advances in treatment, the survival time after breast cancer is prolonged, and as a result, many women face certain diseases during this period. One of these diseases, breast cancer-related lymphedema, is characterized by abnormal accumulation of protein-rich fluid in the interstitial tissue, which can occur at any time after breast cancer surgery or radiotherapy and is a major cause of morbidity.Early and accurate diagnosis of lymphedema is very important for effective treatment. In routine clinical practice there are various methods used to diagnose lymphedema such as history, physical examination and limb circumference. Circumferential measurement is based on the principle of circumference measurement at certain intervals (such as 4 cm, 5 cm, 10 cm) from certain anatomical reference points on the extremities. Volume calculation can also be made from a data obtained from circumferential measurements via a computer program. Circumferential and volume measurements are used in the diagnosis, severity of lymphedema and follow-up of treatment. Although it is the most commonly used method in practice, circumferential measurements and volume measurements alone can ignore changes in tissue structure and significant changes in the presence of latent lymphedema. At the same time, circumferential measurements are made at regular intervals and the difference between the healthy side and 2 cm or more is considered as lymphedema, which may neglect tissue and edema changes in areas not in the measuring area. Ultrasonography, which has been used in the measurement and evaluation of lymphedema in recent years, is a noninvasive economic method. Skin and subcutaneous distance in lymphedema can be measured by ultrasonography, and changes in tissue structure, fibrous tissue, adipose tissue and muscle tissue can be demonstrated. Fibrotic changes in lymphedema tissue play a key role in progression. Subcutaneous ultrasound echogenicity (SEG), which is thought to be a measure of lymphedema severity in extremities, was determined as stages 0, 1 and 2. According to this; Stage 0: No increase in echogenicity in the subcutaneous layer. That is, the subcutaneous fat layer is observed as black. Stage 1: Diffuse increase in echogenicity, but identifiable horizontal or oblique-focused echogenic lines caused by bundles of connective tissue may be seen. In this study, the investigators aimed to determine the correlation between circumferential measurements and skin and subcutaneous tissue ultrasonography in breast cancer-related lymphedema patients.The primer aim of this study is to investigate the correlation between circumferential measurements and ultrasonographic measurements in breast cancer-related lymphedema. The secondary aim is to investigate the relationship among the changes in subcutaneous tissue structure (subcutaneous ultrasound echogenicity degree-SEG) and lymphedema severity in breast cancer-related lymphedema.
Detailed description
Patients with unilateral breast cancer-related lymphedema will be included in the study. The circumferences will be measured with a measuring tape from wrist ulnar styloid to axilla at 4 cm intervals. The point where the difference between the upper extremities was highest and the control point with no difference in the lower extremities will be marked. Ultrasonographic skin and subcutaneous thickness measurements will be performed from 4 quadrants; volar medial-lateral and dorsal medial-lateral sides of the extremity, with the probe placed transverse and perpendicular to the skin at the marked points.
The severity of lymphedema was graded ultrasonographically according to the SEG scale. (Stage 0: No increase in echogenicity in the subcutaneous layer. That is, subcutaneous fat is observed as black. Stage 1: Diffuse increase in echogenicity, but identifiable horizontal or oblique-oriented echogenic lines caused by bundles of connective tissue can be seen. Stage 2: A widespread increase in echogenicity echogenic lines cannot be identified.) Spearman test was used for correlations and Receiver Operating Characteristics (ROC) curve analysis was used to estimate the diagnostic accuracy. Sensitivity and specificity were calculated using a statistically significant threshold. Differences between ultrasonographic measurements between control points in lower extremities were compared with Wilcoxon test.
The minimum number of patients to be included in the study, according to the G-Power program, effect size d = 0.5, alpha-α = 0.05 and power 0.80 was calculated to be at least 34.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| measure | Other | Diagnostic Test: ultrasonographic measurementcircumference measure, ultrasonographic measure |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be diagnosed with breast cancer-related unilateral lymphedema
- Being over 18 years old
- Having a female gender
Key exclusion criteria (5 listed)
- Bilateral breast cancer
- Existing upper extremity infection
- Lymphangitis
- Refusal to participate in the study
- Presence of edema in lower extremity
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 |
|---|---|---|
| ultrasonographic measurementultrasonographic measurement- Subcutaneous ultrasound echogenicity (SEG) and Skin and subcutaneous thickness measurement | Diagnostic test | measure |
Primary outcome
ultrasonographic measurement
Time frame: baseline
- Subcutaneous ultrasound echogenicity (SEG) and Skin and subcutaneous thickness measurement
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 May 2020.
- Derived from this study: PubMed 33601960Erdinc Gunduz N, Dilek B, Sahin E, Ellidokuz H, Akalin E. Diagnostic Contribution of Ultrasonography in Breast Cancer-Related Lymphedema. Lymphat Res Biol. 2021 Dec;19(6):517-523. doi: 10.1089/lrb.2020.0068. Epub 2021 Feb 18.
- 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.
Banu Dilek study director
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasonographic measurement in people with Lymphedema of Upper Arm, run by Dokuz Eylul University at 1 site 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 3 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 May 2020. 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 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?
ultrasonographic measurement (time frame: baseline). 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 NCT04213001, which also lists 1 linked publication.
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 May 2020.