Breast CancerNCT02724514
Multi-Parametric Assessment of Breast Lymphedema
An observational study of Breast Cancer and Breast Lymphedema, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Breast lymphedema (swelling due to fluid) is a common complication of breast cancer therapy. Unlike lymphedema in the arm, breast lymphedema is not as well-known and has not been studied. At present, no objective and standardized tools exist to evaluate breast lymphedema. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Lymphedema
- What is being tested?
- non-invasive image & bioimpedance based techniques
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to 3 Jan 2019
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast lymphedema Cancer patients with lymphedema
Who may be able to join
- At least 18 y/o
- Diagnosis of lymphedema involving the breast
- Diagnosis of in-situ or invasive breast cancer
- Female patients following breast conserving therapy and radiotherapy
- Spoken and written fluency in English; and
- Able to provide informed consent
Who cannot join
- Pacemaker or implanted stimulator or other contraindication to bioimpedance analysis
- Prior breast surgery on the contra lateral breast
- Presence of active cellulitis within the breast, trunk or arm and
- Presence of active cancer
Trial locations and contacts
1 site in 1 country.
About this study
Breast lymphedema (swelling due to fluid) is a common complication of breast cancer therapy. Unlike lymphedema in the arm, breast lymphedema is not as well-known and has not been studied. At present, no objective and standardized tools exist to evaluate breast lymphedema.
The purpose of this study is to investigate the use of ultrasound analysis and bio-impedance to determine if it is possible to measure the extent of the fluid in the breast.
Read the detailed description
Breast lymphedema (swelling due to fluid) is a common complication of breast cancer therapy. Limited research has been conducted on the frequency of breast lymphedema with most studies reporting the incidence as ranging from 33 to 48%. Women with breast lymphedema describe breast fullness, heaviness and pain associated with breast swelling and changes that impacts how the breast looks (cosmesis) and also impacts their quality of life.
At present, no objective and standardized tools exist to evaluate breast lymphedema and correlate it with tissue fluid and fibrosis, and their relationships to local symptoms, cosmesis and quality of life.
The goal of the study is to assess and compare photographic, ultrasound and the breast composition in newly diagnosed breast lymphedema, and to assess the use of breast massage to manage breast lymphedema. Developing non-invasive image-based methods may enable researchers to map the extent of lymphedema, monitor its progression and evaluate therapies. This may allow for improved quantitate measures to be undertaken to better assess future strategies intended to prevent or improve the management of this treatment complication.
Patients participating in this study will have ultrasound scans before and after the massage. They will also be asked to complete a questionnaire.
- Conditions
- Breast Cancer, Breast Lymphedema
- Being tested
- non-invasive image & bioimpedance based techniques
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive image & bioimpedance based techniquesOther
Ultrasound scans, bioimpedance measurements, clinical photographs and questionnaires will be performed before and after the massage.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Mid-Band Fit (MBF) in normal tissue controls and the corresponding regions of lymphedema
The MBF, measured in dB, is a quantitative ultra-sound (QUS) image parameter used to characterize tissue microstructure
Measured: 2 years
Measure Acoustic Scatterer Diameter (ASD) in normal tissue controls and the corresponding regions of lymphedema
The ASD, measured in mm, is a quantitative ultra-sound (QUS) image parameter used to characterize tissue microstructure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completion3 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Dinniwall, MD, Principal investigator, UHN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724514
- Sponsor's protocol ID
- UHN REB 14-8503-C
- Status last verified
- Nov 2019
- First submitted
- 2 Mar 2015
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Parametric Assessment of Breast Lymphedema
- ClinicalTrials.gov ID
- NCT02724514
- Acronym / sponsor ID
- UHN REB 14-8503-C
- Conditions
- Breast Cancer, Breast Lymphedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- 3 Jan 2019 (actual)
- First posted
- 31 Mar 2016 (estimated)
- 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 lymphedema (swelling due to fluid) is a common complication of breast cancer therapy. Unlike lymphedema in the arm, breast lymphedema is not as well-known and has not been studied. At present, no objective and standardized tools exist to evaluate breast lymphedema.
The purpose of this study is to investigate the use of ultrasound analysis and bio-impedance to determine if it is possible to measure the extent of the fluid in the breast.
Detailed description
Breast lymphedema (swelling due to fluid) is a common complication of breast cancer therapy. Limited research has been conducted on the frequency of breast lymphedema with most studies reporting the incidence as ranging from 33 to 48%. Women with breast lymphedema describe breast fullness, heaviness and pain associated with breast swelling and changes that impacts how the breast looks (cosmesis) and also impacts their quality of life.
At present, no objective and standardized tools exist to evaluate breast lymphedema and correlate it with tissue fluid and fibrosis, and their relationships to local symptoms, cosmesis and quality of life.
The goal of the study is to assess and compare photographic, ultrasound and the breast composition in newly diagnosed breast lymphedema, and to assess the use of breast massage to manage breast lymphedema. Developing non-invasive image-based methods may enable researchers to map the extent of lymphedema, monitor its progression and evaluate therapies. This may allow for improved quantitate measures to be undertaken to better assess future strategies intended to prevent or improve the management of this treatment complication.
Patients participating in this study will have ultrasound scans before and after the massage. They will also be asked to complete a questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast lymphedema Cancer patients with lymphedema
Key inclusion criteria (6 listed)
- At least 18 y/o
- Diagnosis of lymphedema involving the breast
- Diagnosis of in-situ or invasive breast cancer
- Female patients following breast conserving therapy and radiotherapy
- Spoken and written fluency in English; and
Key exclusion criteria (4 listed)
- Pacemaker or implanted stimulator or other contraindication to bioimpedance analysis
- Prior breast surgery on the contra lateral breast
- Presence of active cellulitis within the breast, trunk or arm and
- Presence of active cancer
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 |
|---|---|---|
| non-invasive image & bioimpedance based techniquesUltrasound scans, bioimpedance measurements, clinical photographs and questionnaires will be performed before and after the massage. | Other | – |
Primary outcome
Measure Mid-Band Fit (MBF) in normal tissue controls and the corresponding regions of lymphedema
Time frame: 2 years
The MBF, measured in dB, is a quantitative ultra-sound (QUS) image parameter used to characterize tissue microstructure
Measure Acoustic Scatterer Diameter (ASD) in normal tissue controls and the corresponding regions of lymphedema
Time frame: 2 years
The ASD, measured in mm, is a quantitative ultra-sound (QUS) image parameter used to characterize tissue microstructure
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 27 Nov 2019.
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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.
Robert Dinniwall, MD principal investigator
UHN
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 Breast Cancer and Breast Lymphedema, run by University Health Network, Toronto at 1 site in Canada.
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 6 inclusion and 4 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 27 Nov 2019. 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 Canada. 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?
Measure Mid-Band Fit (MBF) in normal tissue controls and the corresponding regions of lymphedema (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2019.