Skip to main content
OpenTrials
Completed

NCT Number: NCT03687749

Presentation of First Time Attenders at Lymphedema Clinics

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lymphedema Breast Diseases Breast Neoplasm Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Sydney, Faculty of Health Sciences, Sydney, New South Wales, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • patients under the age of 18 years

Treatment and study plan

Primary outcomes

  1. 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.

  2. Arm volume

    Time frame: immediately after inclusion in the study

    Arm circumference measures are commonly used to diagnose and monitor lymphedema.

  3. 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.

Secondary outcomes

  1. Self-reported signs and symptoms of lymphedema

    Time frame: immediately after inclusion in the study

    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.

  2. Impairments in function, activity limitations, and participation restrictions of patients with arm lymphedema

    Time frame: immediately after inclusion in the study

    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.

  3. Global Health Status/Quality of Life Score

    Time frame: immediately after inclusion in the study

    Health-related quality of life assessed with the generic QLQ-C30 and the disease-specific QLQ-BR23 questionnaire

  4. Body perception

    Time frame: immediately after inclusion in the study

    The BATH CRPS body perception disturbances scale: to assess body perception disturbances in breast cancer patients.

  5. Pain intensity assessed with the Numeric Rating Scale

    Time frame: immediately after inclusion in the study

    Numeric Rating Scale for maximal pain intensity during the past week.

  6. Prevalence of neuropathic pain

    Time frame: immediately after inclusion in the study

    Measured with the Douleur Neuropathique en 4 questions (DN4)

  7. Tactile acuity (Two-point discrimination)

    Time frame: immediately after inclusion in the study

    To assess body perception two-point discrimination will be assessed at both arms, the breasts and lateral trunk side.

  8. Mechanical detection and pain threshold

    Time frame: immediately after inclusion in the study

    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.

  9. Temporal summation

    Time frame: immediately after inclusion in the study

    Detection of perceived temporal summation at the upper limb and upper body region tested using repeated 26g nylon monofilament stimulation.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • University of Sydney

Registry information

Official study title

Presentation of First Time Attenders at Lymphedema Clinics: Cross-sectional Study

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 27, 2018
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.