LymphoedemaONCOLYMPHNCT07011316
Subclinical Monitoring of Lymphatic Function in Oncology Patients for Lymphoedema Prevention (ONCOLYMPH)
An observational study of Lymphoedema, run by The Greater Poland Cancer Centre at 1 site in Poland.
Trial summary
Lymphoedema, a chronic condition caused by the accumulation of protein-rich fluid in the intercellular spaces due to impaired lymphatic function, is a common complication in cancer patients. It can lead to visible swelling, discomfort, and mobility issues, but most frequently affects the limbs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoedema
- How many people
- 600 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2025to 31 Dec 2029
- Phase
- Observational
- 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
Study population: Individuals affected by lymphoedema experience not only physical symptoms such as inflammation and mobility issues but also psychological effects, including reduced quality of life, social stigma, and challenges in returning to work.
Who may be able to join
- admission to the Greater Poland Cancer Centre for treatment in one of the departments participating in the study,
- age ≥ 18 years,
- ability to balance independently in a standing position for 30 seconds,
- obtaining the patient's written informed consent to participate in the study.
Who cannot join
- age ≤ 18 years,
- cardiac arrhythmia,
- pacemakers or other implanted electronic devices,
- history of external defibrillation,
- pregnancy,
- critical limb ischaemia,
Show all 12Show fewer
- advanced heart failure (NYHA III and IV0),
- symptoms of deep vein thrombosis,
- uncompensated heart, kidney or thyroid failure,
- peripheral nerve damage,
- presence of psychiatric disorders that preclude informed consent or limit appropriate co-operation of the patient,
- lack of informed consent from the patient to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
The Greater Poland Cancer Centre
Poznan, Greater Poland Voivodeship, 61-866
Ewa Tanska, PhD, +48603846282, ewa.tanska@wco.pl
Janusz Doś, PT, PhD, +48606433323, janusz.dos@wco.pl
About this study
Official title: Subclinical Assessment and Monitoring of Lymphatic System Function in Oncology Patients as Part of Physiotherapeutic Prevention of Limb Lymphoedema
Lymphoedema, a chronic condition caused by the accumulation of protein-rich fluid in the intercellular spaces due to impaired lymphatic function, is a common complication in cancer patients. It can lead to visible swelling, discomfort, and mobility issues, but most frequently affects the limbs. This condition not only impacts patients physically but also has significant psychological consequences, including reduced quality of life, social stigma, and challenges with returning to daily activities.
Oncology patients are particularly at risk for developing lymphoedema due to factors such as lymphadenectomy, radiotherapy, and extensive surgical procedures. Up to 30% of breast cancer survivors develop lymphoedema, and it is also a common complication in patients treated for other cancers, such as those involving the cervix, vulva, prostate, and bladder. Despite the importance of early detection, diagnostic tools for assessing lymphatic dysfunction are often specialised and not suitable for routine screening in clinical practice.
The primary goal of this study is to explore the early signs of lymphatic dysfunction in cancer patients before evident clinical symptoms, with the aim of identifying individuals at risk of developing lymphoedema. This will provide valuable information that could guide early interventions and preventive measures to reduce the severity or even prevent the onset of lymphoedema. By focusing on early, subclinical dysfunction, the study seeks to contribute to improving both the clinical management of lymphatic complications and the overall quality of life for oncology patients. Regular monitoring and timely physiotherapy interventions could play a key role in enhancing recovery outcomes and reducing the long-term impact of lymphoedema.
Read the detailed description
Lymphoedema is a chronic condition characterised by an increase in body volume due to the accumulation of protein-rich fluid and cellular debris in the interstitial spaces, resulting from impaired lymphatic vessel function. It can affect various areas of the body, such as the external genitalia, abdomen, and face, but most commonly occurs in the limbs, leading to visible swelling and associated discomfort.
The main risk factors for lymphoedema include lymphadenectomy, radiotherapy, extensive surgical procedures, and obesity. Oncology patients frequently experience this condition as a complication of cancer treatment. According to data from the World Health Organization, up to 30% of breast cancer survivors develop lymphoedema. It is also a common complication in patients treated for other cancers usually as a result of surgical removal of lymph nodes or radiotherapy that damages structures of the lymphatic system (cancer of the: cervix ~ 30%; vulva ~ 27%; sarcoma ~ 27%; penis ~ 25% melanoma ~ 23%; prostate ~ 18%; bladder ~ 15%; testes: ~ 10%).
Lymphoedema diagnosis is based on clinical examination and the exclusion of other causes, primarily chronic venous insufficiency and thrombosis. Standard diagnostic methods like lymphoscintigraphy and indocyanine green (ICG) dye lymphography require specialised equipment and conditions, making them less suitable for routine screening to assess lymphatic damage and the risk of lymphoedema development.
Individuals affected by lymphoedema experience not only physical symptoms such as inflammation and mobility issues but also psychological effects, including reduced quality of life, social stigma, and challenges in returning to work. According to the International Society of Lymphology (ISL), lymphoedema treatment should be interdisciplinary, incorporating a comprehensive range of therapeutic approaches such as pharmacotherapy, surgery, multi-layer compression, pneumatic compression, manual lymphatic drainage, and specialised exercises to enhance lymph flow. As the course of treatment is prolonged and the results are not fully satisfactory, methods and programmes to prevent the formation and development of lymphoedema are of particular importance, both clinically and economically.
Regular monitoring of lymphatic system function in oncology patients and the early implementation of physiotherapy can significantly reduce the risk of lymphoedema or limit its severity, ultimately improving patients' quality of life and recovery outcomes.
Purpose of the research: The aim of the project is to assess early - subclinical peripheral lymphatic system dysfunction resulting from various treatment modalities (surgery, radiotherapy, brachytherapy) in oncology patients. The study will include patients with breast cancer, malignant urinary and genital cancers, both treated surgically and/or with brachytherapy. Recruited patients' body composition will be assessed using non-invasive technology of spectroscopic bioimpedance analysis (BIA) with a body composition analyser - SOZO® Digital Health Platform apparatus. Measurements will be taken three times: (1) before the start of treatment on admission to the hospital, (2) after the applied treatment before the patient is discharged, and (3) at the standard follow-up visit two/three months after the end of treatment in the hospital. The assessment of the efficiency of the lymphatic system provides information on the appropriateness of taking preventive measures to prevent the development of lymphoedema of the limbs.
- Conditions
- Lymphoedema
- Keywords
- Lymphoedema, Cancer, Prevention, bioimpedance spectroscopy
- Medical subject headings
- Lymphedema, 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 |
|---|---|---|
| Main patient cohort | * 150 women with malignant tumours of the urinary and genital systems * 150 men with malignant tumours of the urinary and genital systems * 150 patients with malignant tumours of the nipple (breast) * 150 patients with malignant tumours of the nipple (breast) and malignant tumours of the urinary and genital systems treated with brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
L-Dex ratio
The assessment of lymphoedema will be performed using non-invasive technology of spectroscopic bioimpedance analysis (BIA) with a body composition analyser - SOZO® Digital Health Platform apparatus and measured as L-Dex parameter. L-Dex ratio will be calculated by dividing the bioimpedance reading of the affected limb by the bioimpedance reading of the unaffected limb.
Measured: Time Frame: Metrics assessed at baseline (within two weeks before treatment), after treatment (up to 2 weeks after completing treatment/intervention), and during follow-up (up to 8 weeks ± 2 weeks after completing treatment/intervention)
Secondary outcomes (3)
BMI
Body Mass Index; weight in kilograms (kg) and height in meter (m) will be combined to report BMI in kg/m^2. The parameters will be measured using spectroscopic bioimpedance analysis (BIA) with a body composition analyser - SOZO® Digital Health Platform apparatus.
Measured: Time Frame: Metrics assessed at baseline (within two weeks before treatment), after treatment (up to 2 weeks after completing treatment/intervention), and during follow-up (up to 8 weeks ± 2 weeks after completing treatment/intervention)
Percent body fat
Body fat mass in kilograms (kg) and weight in kilograms (kg) will be combined to report Percent body fat in kg/kg*100 (%). The parameters will be measured using spectroscopic bioimpedance analysis (BIA) with a body composition analyser - SOZO® Digital Health Platform apparatus.
Measured: Time Frame: Metrics assessed at baseline (within two weeks before treatment), after treatment (up to 2 weeks after completing treatment/intervention), and during follow-up (up to 8 weeks ± 2 weeks after completing treatment/intervention)
Percent body water
Total body water mass in kilograms (kg) and weight in kilograms (kg) will be combined to report Percent total body water in kg/kg*100 (%). The parameters will be measured using spectroscopic bioimpedance analysis (BIA) with a body composition analyser - SOZO® Digital Health Platform apparatus.
Measured: Time Frame: Metrics assessed at baseline (within two weeks before treatment), after treatment (up to 2 weeks after completing treatment/intervention), and during follow-up (up to 8 weeks ± 2 weeks after completing treatment/intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for LymphoedemaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Greater Poland Cancer Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Poznan University of Physical Education
- Responsible party
- Sponsor
- Investigators
- Janusz Doś, PT, PhD, Principal investigator, The Greater Poland Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011316
- Sponsor's protocol ID
- ONCOLYMPH
- Acronym
- ONCOLYMPH
- Status last verified
- May 2025
- First submitted
- 28 Apr 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kilgore LJ, Korentager SS, Hangge AN, Amin AL, Balanoff CR, Larson KE, Mitchell MP, Chen JG, Burgen E, Khan QJ, O'Dea AP, Nye L, Sharma P, Wagner JL. Reducing Breast Cancer-Related Lymphedema (BCRL) Through Prospective Surveillance Monitoring Using Bioimpedance Spectroscopy (BIS) and Patient Directed Self-Interventions. Ann Surg Oncol. 2018 Oct;25(10):2948-2952. doi: 10.1245/s10434-018-6601-8. Epub 2018 Jul 9.
PubMed 29987599da Silva Tozzo FCB, Sarri AJ, Pirola WE, da Silva UBC, de Oliveira MA, de Padua Souza C, da Costa Vieira RA. Evaluation of upper limb lymphoedema and diagnostic accuracy of bioimpedance spectroscopy. A comprehensive validation in a Brazilian population. Ecancermedicalscience. 2023 Dec 18;17:1649. doi: 10.3332/ecancer.2023.1649. eCollection 2023.
PubMed 38419858Shah C, Whitworth P, Valente S, Schwarz GS, Kruse M, Kohli M, Brownson K, Lawson L, Dupree B, Vicini FA. Bioimpedance spectroscopy for breast cancer-related lymphedema assessment: clinical practice guidelines. Breast Cancer Res Treat. 2023 Feb;198(1):1-9. doi: 10.1007/s10549-022-06850-7. Epub 2022 Dec 24.
PubMed 36566297Whitworth PW, Shah C, Vicini F, Cooper A. Preventing Breast Cancer-Related Lymphedema in High-Risk Patients: The Impact of a Structured Surveillance Protocol Using Bioimpedance Spectroscopy. Front Oncol. 2018 Jun 12;8:197. doi: 10.3389/fonc.2018.00197. eCollection 2018.
PubMed 29946531Torres Lacomba M, Yuste Sanchez MJ, Zapico Goni A, Prieto Merino D, Mayoral del Moral O, Cerezo Tellez E, Minayo Mogollon E. Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trial. BMJ. 2010 Jan 12;340:b5396. doi: 10.1136/bmj.b5396.
PubMed 20068255Stuiver MM, ten Tusscher MR, Agasi-Idenburg CS, Lucas C, Aaronson NK, Bossuyt PM. Conservative interventions for preventing clinically detectable upper-limb lymphoedema in patients who are at risk of developing lymphoedema after breast cancer therapy. Cochrane Database Syst Rev. 2015 Feb 13;2015(2):CD009765. doi: 10.1002/14651858.CD009765.pub2.
PubMed 25677413Rio-Gonzalez A, Molina-Rueda F, Palacios-Cena D, Alguacil-Diego IM. Living with lymphoedema-the perspective of cancer patients: a qualitative study. Support Care Cancer. 2018 Jun;26(6):2005-2013. doi: 10.1007/s00520-018-4048-x. Epub 2018 Jan 12.
PubMed 29330708Ridner SH, Dietrich MS, Boyages J, Koelmeyer L, Elder E, Hughes TM, French J, Ngui N, Hsu J, Abramson VG, Moore A, Shah C. A Comparison of Bioimpedance Spectroscopy or Tape Measure Triggered Compression Intervention in Chronic Breast Cancer Lymphedema Prevention. Lymphat Res Biol. 2022 Dec;20(6):618-628. doi: 10.1089/lrb.2021.0084. Epub 2022 Jan 28.
PubMed 35099283Park JH, Lee WH, Chung HS. Incidence and risk factors of breast cancer lymphoedema. J Clin Nurs. 2008 Jun;17(11):1450-9. doi: 10.1111/j.1365-2702.2007.02187.x.
PubMed 18482142Naczk A, Dos J, Gorska-Dos M, Sibilski R, Gramza P, Gajewska E, Naczk M. Relationship between Viscoelastic Properties of Tissues and Bioimpedance Spectroscopy in Breast-Cancer-Related Lymphedema. J Clin Med. 2022 Feb 26;11(5):1294. doi: 10.3390/jcm11051294.
PubMed 35268385Box RC, Reul-Hirche HM, Bullock-Saxton JE, Furnival CM. Physiotherapy after breast cancer surgery: results of a randomised controlled study to minimise lymphoedema. Breast Cancer Res Treat. 2002 Sep;75(1):51-64. doi: 10.1023/a:1016591121762.
PubMed 12500934
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subclinical Assessment and Monitoring of Lymphatic System Function in Oncology Patients as Part of Physiotherapeutic Prevention of Limb Lymphoedema
- ClinicalTrials.gov ID
- NCT07011316
- Acronym / sponsor ID
- ONCOLYMPH / ONCOLYMPH
- Conditions
- Lymphoedema
- Keywords
- Lymphoedema, Cancer, Prevention, bioimpedance spectroscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The Greater Poland Cancer CentreUniversity, hospital or other
- Collaborators
- Poznan University of Physical Education
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 8 Jun 2025 (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.
Lymphoedema, a chronic condition caused by the accumulation of protein-rich fluid in the intercellular spaces due to impaired lymphatic function, is a common complication in cancer patients. It can lead to visible swelling, discomfort, and mobility issues, but most frequently affects the limbs. This condition not only impacts patients physically but also has significant psychological consequences, including reduced quality of life, social stigma, and challenges with returning to daily activities.
Oncology patients are particularly at risk for developing lymphoedema due to factors such as lymphadenectomy, radiotherapy, and extensive surgical procedures. Up to 30% of breast cancer survivors develop lymphoedema, and it is also a common complication in patients treated for other cancers, such as those involving the cervix, vulva, prostate, and bladder. Despite the importance of early detection, diagnostic tools for assessing lymphatic dysfunction are often specialised and not suitable for routine screening in clinical practice.
The primary goal of this study is to explore the early signs of lymphatic dysfunction in cancer patients before evident clinical symptoms, with the aim of identifying individuals at risk of developing lymphoedema. This will provide valuable information that could guide early interventions and preventive measures to reduce the severity or even prevent the onset of lymphoedema. By focusing on early, subclinical dysfunction, the study seeks to contribute to improving both the clinical management of lymphatic complications and the overall quality of life for oncology patients. Regular monitoring and timely physiotherapy interventions could play a key role in enhancing recovery outcomes and reducing the long-term impact of lymphoedema.
Detailed description
Lymphoedema is a chronic condition characterised by an increase in body volume due to the accumulation of protein-rich fluid and cellular debris in the interstitial spaces, resulting from impaired lymphatic vessel function. It can affect various areas of the body, such as the external genitalia, abdomen, and face, but most commonly occurs in the limbs, leading to visible swelling and associated discomfort.
The main risk factors for lymphoedema include lymphadenectomy, radiotherapy, extensive surgical procedures, and obesity. Oncology patients frequently experience this condition as a complication of cancer treatment. According to data from the World Health Organization, up to 30% of breast cancer survivors develop lymphoedema. It is also a common complication in patients treated for other cancers usually as a result of surgical removal of lymph nodes or radiotherapy that damages structures of the lymphatic system (cancer of the: cervix ~ 30%; vulva ~ 27%; sarcoma ~ 27%; penis ~ 25% melanoma ~ 23%; prostate ~ 18%; bladder ~ 15%; testes: ~ 10%).
Lymphoedema diagnosis is based on clinical examination and the exclusion of other causes, primarily chronic venous insufficiency and thrombosis. Standard diagnostic methods like lymphoscintigraphy and indocyanine green (ICG) dye lymphography require specialised equipment and conditions, making them less suitable for routine screening to assess lymphatic damage and the risk of lymphoedema development.
Individuals affected by lymphoedema experience not only physical symptoms such as inflammation and mobility issues but also psychological effects, including reduced quality of life, social stigma, and challenges in returning to work. According to the International Society of Lymphology (ISL), lymphoedema treatment should be interdisciplinary, incorporating a comprehensive range of therapeutic approaches such as pharmacotherapy, surgery, multi-layer compression, pneumatic compression, manual lymphatic drainage, and specialised exercises to enhance lymph flow. As the course of treatment is prolonged and the results are not fully satisfactory, methods and programmes to prevent the formation and development of lymphoedema are of particular importance, both clinically and economically.
Regular monitoring of lymphatic system function in oncology patients and the early implementation of physiotherapy can significantly reduce the risk of lymphoedema or limit its severity, ultimately improving patients' quality of life and recovery outcomes.
Purpose of the research: The aim of the project is to assess early - subclinical peripheral lymphatic system dysfunction resulting from various treatment modalities (surgery, radiotherapy, brachytherapy) in oncology patients. The study will include patients with breast cancer, malignant urinary and genital cancers, both treated surgically and/or with brachytherapy. Recruited patients' body composition will be assessed using non-invasive technology of spectroscopic bioimpedance analysis (BIA) with a body composition analyser - SOZO® Digital Health Platform apparatus. Measurements will be taken three times: (1) before the start of treatment on admission to the hospital, (2) after the applied treatment before the patient is discharged, and (3) at the standard follow-up visit two/three months after the end of treatment in the hospital. The assessment of the efficiency of the lymphatic system provides information on the appropriateness of taking preventive measures to prevent the development of lymphoedema of the limbs.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main patient cohort | – | –* 150 women with malignant tumours of the urinary and genital systems * 150 men with malignant tumours of the urinary and genital systems * 150 patients with malignant tumours of the nipple (breast) * 150 patients with malignant tumours of the nipple (breast) and malignant tumours of the urinary and genital systems treated with brachytherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals affected by lymphoedema experience not only physical symptoms such as inflammation and mobility issues but also psychological effects, including reduced quality of life, social stigma, and challenges in returning to work.
Key inclusion criteria (4 listed)
- admission to the Greater Poland Cancer Centre for treatment in one of the departments participating in the study,
- age ≥ 18 years,
- ability to balance independently in a standing position for 30 seconds,
- obtaining the patient's written informed consent to participate in the study.
Key exclusion criteria (12 listed)
- age ≤ 18 years,
- cardiac arrhythmia,
- pacemakers or other implanted electronic devices,
- history of external defibrillation,
- pregnancy,
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
L-Dex ratio
Time frame: Time Frame: Metrics assessed at baseline (within two weeks before treatment), after treatment (up to 2 weeks after completing treatment/intervention), and during follow-up (up to 8 weeks ± 2 weeks after completing treatment/intervention)
The assessment of lymphoedema will be performed using non-invasive technology of spectroscopic bioimpedance analysis (BIA) with a body composition analyser - SOZO® Digital Health Platform apparatus and measured as L-Dex parameter. L-Dex ratio will be calculated by dividing the bioimpedance reading of the affected limb by the bioimpedance reading of the unaffected limb.
3 secondary outcomes
BMI
Time frame: Time Frame: Metrics assessed at baseline (within two weeks before treatment), after treatment (up to 2 weeks after completing treatment/intervention), and during follow-up (up to 8 weeks ± 2 weeks after completing treatment/intervention)
Percent body fat
Time frame: Time Frame: Metrics assessed at baseline (within two weeks before treatment), after treatment (up to 2 weeks after completing treatment/intervention), and during follow-up (up to 8 weeks ± 2 weeks after completing treatment/intervention)
Percent body water
Time frame: Time Frame: Metrics assessed at baseline (within two weeks before treatment), after treatment (up to 2 weeks after completing treatment/intervention), and during follow-up (up to 8 weeks ± 2 weeks after completing treatment/intervention)
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 8 Jun 2025.
- Background: PubMed 29987599Kilgore LJ, Korentager SS, Hangge AN, Amin AL, Balanoff CR, Larson KE, Mitchell MP, Chen JG, Burgen E, Khan QJ, O'Dea AP, Nye L, Sharma P, Wagner JL. Reducing Breast Cancer-Related Lymphedema (BCRL) Through Prospective Surveillance Monitoring Using Bioimpedance Spectroscopy (BIS) and Patient Directed Self-Interventions. Ann Surg Oncol. 2018 Oct;25(10):2948-2952. doi: 10.1245/s10434-018-6601-8. Epub 2018 Jul 9.
- Background: PubMed 38419858da Silva Tozzo FCB, Sarri AJ, Pirola WE, da Silva UBC, de Oliveira MA, de Padua Souza C, da Costa Vieira RA. Evaluation of upper limb lymphoedema and diagnostic accuracy of bioimpedance spectroscopy. A comprehensive validation in a Brazilian population. Ecancermedicalscience. 2023 Dec 18;17:1649. doi: 10.3332/ecancer.2023.1649. eCollection 2023.
- Background: PubMed 36566297Shah C, Whitworth P, Valente S, Schwarz GS, Kruse M, Kohli M, Brownson K, Lawson L, Dupree B, Vicini FA. Bioimpedance spectroscopy for breast cancer-related lymphedema assessment: clinical practice guidelines. Breast Cancer Res Treat. 2023 Feb;198(1):1-9. doi: 10.1007/s10549-022-06850-7. Epub 2022 Dec 24.
- Background: PubMed 29946531Whitworth PW, Shah C, Vicini F, Cooper A. Preventing Breast Cancer-Related Lymphedema in High-Risk Patients: The Impact of a Structured Surveillance Protocol Using Bioimpedance Spectroscopy. Front Oncol. 2018 Jun 12;8:197. doi: 10.3389/fonc.2018.00197. eCollection 2018.
- Background: PubMed 20068255Torres Lacomba M, Yuste Sanchez MJ, Zapico Goni A, Prieto Merino D, Mayoral del Moral O, Cerezo Tellez E, Minayo Mogollon E. Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trial. BMJ. 2010 Jan 12;340:b5396. doi: 10.1136/bmj.b5396.
- Background: PubMed 25677413Stuiver MM, ten Tusscher MR, Agasi-Idenburg CS, Lucas C, Aaronson NK, Bossuyt PM. Conservative interventions for preventing clinically detectable upper-limb lymphoedema in patients who are at risk of developing lymphoedema after breast cancer therapy. Cochrane Database Syst Rev. 2015 Feb 13;2015(2):CD009765. doi: 10.1002/14651858.CD009765.pub2.
- Background: PubMed 29330708Rio-Gonzalez A, Molina-Rueda F, Palacios-Cena D, Alguacil-Diego IM. Living with lymphoedema-the perspective of cancer patients: a qualitative study. Support Care Cancer. 2018 Jun;26(6):2005-2013. doi: 10.1007/s00520-018-4048-x. Epub 2018 Jan 12.
- Background: PubMed 35099283Ridner SH, Dietrich MS, Boyages J, Koelmeyer L, Elder E, Hughes TM, French J, Ngui N, Hsu J, Abramson VG, Moore A, Shah C. A Comparison of Bioimpedance Spectroscopy or Tape Measure Triggered Compression Intervention in Chronic Breast Cancer Lymphedema Prevention. Lymphat Res Biol. 2022 Dec;20(6):618-628. doi: 10.1089/lrb.2021.0084. Epub 2022 Jan 28.
- Background: PubMed 18482142Park JH, Lee WH, Chung HS. Incidence and risk factors of breast cancer lymphoedema. J Clin Nurs. 2008 Jun;17(11):1450-9. doi: 10.1111/j.1365-2702.2007.02187.x.
- Background: PubMed 35268385Naczk A, Dos J, Gorska-Dos M, Sibilski R, Gramza P, Gajewska E, Naczk M. Relationship between Viscoelastic Properties of Tissues and Bioimpedance Spectroscopy in Breast-Cancer-Related Lymphedema. J Clin Med. 2022 Feb 26;11(5):1294. doi: 10.3390/jcm11051294.
- Background: PubMed 12500934Box RC, Reul-Hirche HM, Bullock-Saxton JE, Furnival CM. Physiotherapy after breast cancer surgery: results of a randomised controlled study to minimise lymphoedema. Breast Cancer Res Treat. 2002 Sep;75(1):51-64. doi: 10.1023/a:1016591121762.
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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.
Janusz Doś, PT, PhD principal investigator
The Greater Poland Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoedema, run by The Greater Poland Cancer Centre at 1 site in Poland.
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 12 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: looking for participants now, as of the sponsor's last update on 8 Jun 2025. 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 Poland. 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?
Contact Ewa Tańska, PhD (+48618850767, ewa.tanska@wco.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
L-Dex ratio (time frame: Time Frame: Metrics assessed at baseline (within two weeks before treatment), after treatment (up to 2 weeks after completing treatment/intervention), and during follow-up (up to 8 weeks ± 2 weeks after completing treatment/intervention)). 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 NCT07011316, which also lists 11 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 8 Jun 2025.