Subclinical Monitoring of Lymphatic Function in Oncology Patients for Lymphoedema Prevention (ONCOLYMPH)

NCT07011316 | Recruiting

• 1 other identifier: ONCOLYMPH
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lymphoedema

Keywords

Lymphoedema; Cancer; Prevention; bioimpedance spectroscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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: 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: 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)

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• age ≤ 18 years,
• cardiac arrhythmia,
• pacemakers or other implanted electronic devices,
• history of external defibrillation,
• pregnancy,
• critical limb ischaemia,
• 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.

Sponsors & Collaborators

• The Greater Poland Cancer Centre: lead
• Poznan University of Physical Education: collaborator

Study Sites (1)

The Greater Poland Cancer Centre

Poznan, Greater Poland Voivodeship, 61-866, Poland

RECRUITING

Related Publications (11)

• 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.

  PMID: 29987599 BACKGROUND

• da 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.

  PMID: 38419858 BACKGROUND

• Shah 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.

  PMID: 36566297 BACKGROUND

• Whitworth 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.

  PMID: 29946531 BACKGROUND

• Torres 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.

  PMID: 20068255 BACKGROUND

• Stuiver 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.

  PMID: 25677413 BACKGROUND

• Rio-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.

  PMID: 29330708 BACKGROUND

• Ridner 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.

  PMID: 35099283 BACKGROUND

• Park 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.

  PMID: 18482142 BACKGROUND

• Naczk 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.

  PMID: 35268385 BACKGROUND

• Box 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.

  PMID: 12500934 BACKGROUND

MeSH Terms

Conditions

Lymphedema; Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Janusz Doś, PT, PhD

  The Greater Poland Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ewa Tańska, PhD

CONTACT

+48618850767; ewa.tanska@wco.pl

Janusz Doś, PT, PhD

CONTACT

+48618850560; janusz.dos@wco.pl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: June 8, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 8, 2025

Record last verified: 2025-05

Locations

PL (1)