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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03687749




Registration number
NCT03687749
Ethics application status
Date submitted
10/07/2018
Date registered
27/09/2018
Date last updated
27/09/2018

Titles & IDs
Public title
Presentation of First Time Attenders at Lymphedema Clinics
Scientific title
Presentation of First Time Attenders at Lymphedema Clinics: Cross-sectional Study
Secondary ID [1] 0 0
S59883
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphedema 0 0
Breast Neoplasm 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Women with breast cancer-related lymphedema - Individuals with upper limb lymphedema developed after breast cancer treatment

Healthy control subjects - Healthy individuals without breast cancer-related lymphoedema.

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Extracellular fluid in the arm - Bioimpedance spectroscopy (BIS) is a measurement tool used to determine the volume of extracellular fluid, of which lymph fluid is a component.
Timepoint [1] 0 0
immediately after inclusion in the study
Primary outcome [2] 0 0
Arm volume - Arm circumference measures are commonly used to diagnose and monitor lymphedema.
Timepoint [2] 0 0
immediately after inclusion in the study
Primary outcome [3] 0 0
Pitting - The pitting tests examines the responsiveness of tissue to pressure and can be used to help determine the stage of lymphedema.
Timepoint [3] 0 0
immediately after inclusion in the study
Secondary outcome [1] 0 0
Self-reported signs and symptoms of lymphedema - 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.
Timepoint [1] 0 0
immediately after inclusion in the study
Secondary outcome [2] 0 0
Impairments in function, activity limitations, and participation restrictions of patients with arm lymphedema - 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.
Timepoint [2] 0 0
immediately after inclusion in the study
Secondary outcome [3] 0 0
Global Health Status/Quality of Life Score - Health-related quality of life assessed with the generic QLQ-C30 and the disease-specific QLQ-BR23 questionnaire
Timepoint [3] 0 0
immediately after inclusion in the study
Secondary outcome [4] 0 0
Body perception - The BATH CRPS body perception disturbances scale: to assess body perception disturbances in breast cancer patients.
Timepoint [4] 0 0
immediately after inclusion in the study
Secondary outcome [5] 0 0
Pain intensity assessed with the Numeric Rating Scale - Numeric Rating Scale for maximal pain intensity during the past week.
Timepoint [5] 0 0
immediately after inclusion in the study
Secondary outcome [6] 0 0
Prevalence of neuropathic pain - Measured with the Douleur Neuropathique en 4 questions (DN4)
Timepoint [6] 0 0
immediately after inclusion in the study
Secondary outcome [7] 0 0
Tactile acuity (Two-point discrimination) - To assess body perception two-point discrimination will be assessed at both arms, the breasts and lateral trunk side.
Timepoint [7] 0 0
immediately after inclusion in the study
Secondary outcome [8] 0 0
Mechanical detection and pain threshold - 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.
Timepoint [8] 0 0
immediately after inclusion in the study
Secondary outcome [9] 0 0
Temporal summation - Detection of perceived temporal summation at the upper limb and upper body region tested using repeated 26g nylon monofilament stimulation.
Timepoint [9] 0 0
immediately after inclusion in the study

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- patients under the age of 18 years

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of Sydney, Faculty of Health Sciences - Sydney
Recruitment postcode(s) [1] 0 0
2006 - Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven

Funding & Sponsors
Primary sponsor type
Other
Name
Universitaire Ziekenhuizen Leuven
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03687749
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
An De Groef, PhD
Address 0 0
Universitaire Ziekenhuizen Leuven
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
An De Groef, PhD
Address 0 0
Country 0 0
Phone 0 0
+32 16 342 171
Fax 0 0
Email 0 0
an.degroef@kuleuven.be
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03687749