LymphedemaNCT01599039
Study the Usefulness of Bio-impedance Spectroscopy in the Early Assessment of Breast Cancer Related Lymphoedema
An observational study of Lymphedema and Breast Cancer Stage II, run by Nij Smellinghe Hosptial at 1 site in Netherlands.
Trial summary
The goal of the study is to investigate the use of bio-impedance spectroscopy in the assessment of breast cancer related lymphoedema in patients operated with lumpectomy or mastectomy, axillary lymph node dissection and radiotherapy compared to inverse water volumetry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema, Breast Cancer Stage II, Early Disease Onset
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2012to Jan 2016
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: There study population consists of breast cancer patients treated with either sentinel node biopsy either axillary dissection. As a control group we use colorectal cancer patients
Who may be able to join
- Gender: female
- Patients operated with lumpectomy or mastectomy, Sentinel node, axillary lymphnode dissection and/or chemotherapy and/or radiotherapy.
- Controls: operated for colon-rectal carcinoma with colectomy and adjuvant chemotherapy
- Patients 18 years or older
- No pre-existing clinical or volumetric signs of lymphoedema (CBO guideline: >10% difference with contra-lateral side
Who cannot join
- Allergy against one of the used materials
- Patients who have a pacemaker or other inbuilt stimulator
- Women who are pregnant
- Patients with renal failure or heart failure
- Lymphoedema
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital
Drachten, Provincie Friesland, 9202 NN
About this study
Official title: Prospective Controlled Study Comparing the Effectiveness and Specificity of Inverse Water Volumetry Versus Bio-impedance Spectroscopy in the Assessment of Early Recognition of Breast Cancer Related Lymphoedema.
The goal of the study is to investigate the use of bio-impedance spectroscopy in the assessment of breast cancer related lymphoedema in patients operated with lumpectomy or mastectomy, axillary lymph node dissection and radiotherapy compared to inverse water volumetry. As a control group, patients with colon rectal cancer are used to compare volumetric and spectometric changes during follow-up.
Read the detailed description
Current assessment of lymphoedema consists of measuring volume changes objectively by a tape measure or water displacement. Early recognition of pre-clinical changes of interstitial fluid congestion in a limb at risk concerning lymph transport capacity is crucial. Objective measurement of extracellular fluids with bio-impedance spectroscopy can detect these early signs of lymphoedema. Multi Frequency Bioelectrical Impedance Analysis is completely non-invasive, highly reproducible (Ward et al 1997), highly sensitive (Cornish et al 2001), highly specific (Cornish et al 2001) and can be repeated as frequently as desired. BIS demonstrated excellent inter- and intra-rater reliability. All measures are highly reliably in women with and without lymphoedema (Szerniec et al 2010). For women with lymphoedema BIS detected a difference in the ECF in limbs which were not reflected in a corresponding difference in limb volume. This finding suggests that BIS may be particularly useful in the early detection of lymphoedema, before there is any volume change (Szerniez et al 2010). The mean ratio of extra cellular water (ECW) to intracellular water (ICW) is 1,5:1 (Ward et al 2009). Cornish et al (2001) predicted the onset of the condition up to 10 months before the condition could be clinically diagnosed. This is considerable shorter than the mean delay time of 3,5 years reported by National Summit on Lymphoedema, Adelaide 2000. The only risk factor identified as contributing to an increased risk of developing secondary lymphoedema was an increasing BMI which is consistent with previous reports (Box et al 2002).
Early detection with BIS is supposed possible even before clinical signs of swelling are available.
In this study we want to study this hypothesis and as control-group patients treated for colorectal carcinoma.
- Conditions
- Lymphedema, Breast Cancer Stage II, Early Disease Onset
- Keywords
- early diagnostics, lymphedema, breast cancer, breast cancer related lymphedema, measuring methods, inverse water volumetry, prevention
- Medical subject headings
- Lymphedema, Breast Neoplasms, Breast Cancer Lymphedema
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 |
|---|---|---|
| breast cancer patients with SN | 1. Breast cancer patients with sentinel node biopsy (n=25) | |
| breast cancer patients with AD | 2. Breast cancer patients with axillary dissection (n=25) | |
| colo-rectal patients | 3. Colo-rectal patients as control group (n=25) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bio impedance spectometry
The participant's height (to 1 mm) and weight (to 0.1 kg) are measured prior to BIS assessment and entered into the device for processing. Whole arm impedance (wrist to axilla) will be determined according to the principle of equipotentials; a method shown to have greater precision than a 'paired electrode' approach. Participants were positioned in supine on a non-conductive bed with their arms by their side, pronated and slightly abducted. These result are compared with the gold standard (Inverse watter volumetry)
Measured: 2 years
Secondary outcomes (2)
body Mass Index (BMI)
The body mass index (or BMI) is a measure which shows whether people have the right weight for their height. The World Health Organisation (WHO), governments and health workers use it. It is also called the Quetelet Index.
Measured: 2 years
quality of life measurement with the " LAST" meter
The "lastmeter" is a validated tool in the Dutch language to score the psycho-social and physical situation of a cancer patient. The scale is between 0-10 and includes several questions. This indicates the need for addition support by healthcare workers to improve QoL
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 posted15 May 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2014
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies 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
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nij Smellinghe Hosptial
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R.J. Damstra, Nij Smellinghe Hosptial
- Investigators
- Robert J Damstra, PhD, Principal investigator, Nij smellinghe hospital, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599039
- Sponsor's protocol ID
- NS3NL
- Status last verified
- Sep 2016
- First submitted
- 13 May 2012
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Controlled Study Comparing the Effectiveness and Specificity of Inverse Water Volumetry Versus Bio-impedance Spectroscopy in the Assessment of Early Recognition of Breast Cancer Related Lymphoedema.
- ClinicalTrials.gov ID
- NCT01599039
- Acronym / sponsor ID
- NS3NL
- Conditions
- Lymphedema, Breast Cancer Stage II, Early Disease Onset
- Keywords
- early diagnostics, lymphedema, breast cancer, breast cancer related lymphedema, measuring methods, inverse water volumetry, prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nij Smellinghe HosptialUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 15 May 2012 (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.
The goal of the study is to investigate the use of bio-impedance spectroscopy in the assessment of breast cancer related lymphoedema in patients operated with lumpectomy or mastectomy, axillary lymph node dissection and radiotherapy compared to inverse water volumetry. As a control group, patients with colon rectal cancer are used to compare volumetric and spectometric changes during follow-up.
Detailed description
Current assessment of lymphoedema consists of measuring volume changes objectively by a tape measure or water displacement. Early recognition of pre-clinical changes of interstitial fluid congestion in a limb at risk concerning lymph transport capacity is crucial. Objective measurement of extracellular fluids with bio-impedance spectroscopy can detect these early signs of lymphoedema. Multi Frequency Bioelectrical Impedance Analysis is completely non-invasive, highly reproducible (Ward et al 1997), highly sensitive (Cornish et al 2001), highly specific (Cornish et al 2001) and can be repeated as frequently as desired. BIS demonstrated excellent inter- and intra-rater reliability. All measures are highly reliably in women with and without lymphoedema (Szerniec et al 2010). For women with lymphoedema BIS detected a difference in the ECF in limbs which were not reflected in a corresponding difference in limb volume. This finding suggests that BIS may be particularly useful in the early detection of lymphoedema, before there is any volume change (Szerniez et al 2010). The mean ratio of extra cellular water (ECW) to intracellular water (ICW) is 1,5:1 (Ward et al 2009). Cornish et al (2001) predicted the onset of the condition up to 10 months before the condition could be clinically diagnosed. This is considerable shorter than the mean delay time of 3,5 years reported by National Summit on Lymphoedema, Adelaide 2000. The only risk factor identified as contributing to an increased risk of developing secondary lymphoedema was an increasing BMI which is consistent with previous reports (Box et al 2002).
Early detection with BIS is supposed possible even before clinical signs of swelling are available.
In this study we want to study this hypothesis and as control-group patients treated for colorectal carcinoma.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| breast cancer patients with SN | – | –1. Breast cancer patients with sentinel node biopsy (n=25) |
| breast cancer patients with AD | – | –2. Breast cancer patients with axillary dissection (n=25) |
| colo-rectal patients | – | –3. Colo-rectal patients as control group (n=25) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There study population consists of breast cancer patients treated with either sentinel node biopsy either axillary dissection. As a control group we use colorectal cancer patients
Key inclusion criteria (5 listed)
- Gender: female
- Patients operated with lumpectomy or mastectomy, Sentinel node, axillary lymphnode dissection and/or chemotherapy and/or radiotherapy.
- Controls: operated for colon-rectal carcinoma with colectomy and adjuvant chemotherapy
- Patients 18 years or older
- No pre-existing clinical or volumetric signs of lymphoedema (CBO guideline: >10% difference with contra-lateral side
Key exclusion criteria (5 listed)
- Allergy against one of the used materials
- Patients who have a pacemaker or other inbuilt stimulator
- Women who are pregnant
- Patients with renal failure or heart failure
- Lymphoedema
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
Bio impedance spectometry
Time frame: 2 years
The participant's height (to 1 mm) and weight (to 0.1 kg) are measured prior to BIS assessment and entered into the device for processing. Whole arm impedance (wrist to axilla) will be determined according to the principle of equipotentials; a method shown to have greater precision than a 'paired electrode' approach. Participants were positioned in supine on a non-conductive bed with their arms by their side, pronated and slightly abducted. These result are compared with the gold standard (Inverse watter volumetry)
2 secondary outcomes
body Mass Index (BMI)
Time frame: 2 years
quality of life measurement with the " LAST" meter
Time frame: 2 years
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 Sep 2016.
- The foundation related to the expert centre organizing researchLink provided by the sponsor.
- General website form the Nij Smellinghe hospitalLink provided by the sponsor.
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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 J Damstra, PhD principal investigator
Nij smellinghe hospital, Netherlands
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 Lymphedema and Breast Cancer Stage II, run by Nij Smellinghe Hosptial at 1 site in Netherlands.
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 5 inclusion and 5 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 Sep 2016. 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 Netherlands. 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?
Bio impedance spectometry (time frame: 2 years). 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 Sep 2016.