Breast CancerL-DexNCT01521000
The Use of Bioimpedance to Determine Pre-Clinical Lymphedema in the Post-Operative Breast Cancer Patient
A study testing Garment Sleeve in people with Breast Cancer, run by Main Line Health at 1 site in United States.
Trial summary
Primary Objective: To determine whether early intervention (with garment sleeve and gauntlet) in patients with pre-clinical lymphedema can halt the progression of lymphedema. Secondary Objectives:To evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Garment Sleeve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2012
- Phase
- Interventional
- 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
Who may be able to join
- are female
- have operable, early stage breast cancer stage 0 - IIIA
- undergo axillary evaluation with either sentinel lymph node biopsy or axillary lymph node dissection
- are aged > 18 years of age at the date of enrollment
- are willing to sign an informed consent form
Who cannot join
- are male
- have had a bilateral axillary surgery
- do not undergo axillary evaluation
- are a minor
- cannot consider the issues involved in making an informed and autonomous decision.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Comprehensive Breast Center at Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Andrea V Barrio, MD
About this study
Primary Objective: To determine whether early intervention (with garment sleeve and gauntlet) in patients with pre-clinical lymphedema can halt the progression of lymphedema.
Secondary Objectives:To evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema.
Read more
Tertiary Objective: To determine whether bioimpedance analysis is better than the gold standard of volume displacement to measure lymphedema.
The successful completion of this study will address whether bioimpedance analysis is a reliable, accurate method to measure pre-clinical and clinical lymphedema. In addition, we intend to evaluate whether bioimpedance analysis is better than the gold standard of volume displacement for measuring lymphedema. And most importantly, we will evaluate whether a short trial of compression garments in women identified to have pre-clinical lymphedema can actually halt the progression of disease. Bryn Mawr Hospital would propose to publish the research and findings of this study, which may have future bearing on the post-operative therapeutic management of subjects with pre-clinical lymphedema following axillary surgery.
Study Design:Randomized, Pilot Study
Read the detailed description
Primary Objective: To determine whether early intervention (with garment sleeve and gauntlet) in patients with pre-clinical lymphedema can halt the progression of lymphedema.
Secondary Objectives:To evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema.
Tertiary Objective: To determine whether bioimpedance analysis is better than the gold standard of volume displacement to measure lymphedema.
- Conditions
- Breast Cancer
- Being tested
- Garment Sleeve
- Keywords
- Breast Cancer, Lymphedema, Sentinel Node Biopsy, Axillary Dissection
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garment SleeveDevice
compression sleeve (20 to 30 mm of Hg)
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | Observation arm will continue to be followed with serial L-Dex and water volume displacement methods. Receives: Device: Garment Sleeve |
| Intervention-garment sleeve | Other | If the L-Dex is outside the normal range, or has increased 10 units from baseline, the patient will then be randomized to wear a compression sleeve (20 to 30 mm of Hg) daily for 4 weeks or observation (no sleeve). After 4 weeks, L-Dex measurements and water volume displacement will be reassessed in the treatment group. Receives: Device: Garment Sleeve |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether early intervention in patients with pre-clinical lymphedema can halt the progression of lymphedema.
Evaluate whether a short trial of compression garments in women identified to have pre-clinical lymphedema can actually halt the progression of disease.
Measured: 2 years
Secondary outcomes (1)
200 women will have bioimpedance and volume displacement measurements to evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema as compared to standard (volume displacement)
Evaluate whether bioimpedance analysis is better than the gold standard of volume displacement for measuring lymphedema.
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 posted30 Jan 2012 (estimated)
- Study startJul 2010
- Primary completionJul 2012 (estimated)
- Study completionDec 2012 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Main Line Health
- Sponsor type
- University, hospital or other
- Collaborators
- Sharpe-Strumia Research Foundation
- Responsible party
- Sponsor
- Investigators
- Andrea V Barrio, MD, Principal investigator, Bryn Mawr Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521000
- Sponsor's protocol ID
- F/N-R10-2932B
- Acronym
- L-Dex
- Status last verified
- Jan 2012
- First submitted
- 9 Feb 2011
- Last updated
- 30 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Bioimpedance to Determine Pre-Clinical Lymphedema in the Post-Operative Breast Cancer Patient
- ClinicalTrials.gov ID
- NCT01521000
- Acronym / sponsor ID
- L-Dex / F/N-R10-2932B
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Lymphedema, Sentinel Node Biopsy, Axillary Dissection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Main Line HealthUniversity, hospital or other
- Collaborators
- Sharpe-Strumia Research Foundation
- Study start
- Jul 2010
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 30 Jan 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.
Primary Objective: To determine whether early intervention (with garment sleeve and gauntlet) in patients with pre-clinical lymphedema can halt the progression of lymphedema.
Secondary Objectives:To evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema.
Tertiary Objective: To determine whether bioimpedance analysis is better than the gold standard of volume displacement to measure lymphedema.
The successful completion of this study will address whether bioimpedance analysis is a reliable, accurate method to measure pre-clinical and clinical lymphedema. In addition, we intend to evaluate whether bioimpedance analysis is better than the gold standard of volume displacement for measuring lymphedema. And most importantly, we will evaluate whether a short trial of compression garments in women identified to have pre-clinical lymphedema can actually halt the progression of disease. Bryn Mawr Hospital would propose to publish the research and findings of this study, which may have future bearing on the post-operative therapeutic management of subjects with pre-clinical lymphedema following axillary surgery.
Study Design:Randomized, Pilot Study
Detailed description
Primary Objective: To determine whether early intervention (with garment sleeve and gauntlet) in patients with pre-clinical lymphedema can halt the progression of lymphedema.
Secondary Objectives:To evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema.
Tertiary Objective: To determine whether bioimpedance analysis is better than the gold standard of volume displacement to measure lymphedema.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | Device: Garment SleeveObservation arm will continue to be followed with serial L-Dex and water volume displacement methods. |
| Intervention-garment sleeve | Other | Device: Garment SleeveIf the L-Dex is outside the normal range, or has increased 10 units from baseline, the patient will then be randomized to wear a compression sleeve (20 to 30 mm of Hg) daily for 4 weeks or observation (no sleeve). After 4 weeks, L-Dex measurements and water volume displacement will be reassessed in the treatment group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- are female
- have operable, early stage breast cancer stage 0 - IIIA
- undergo axillary evaluation with either sentinel lymph node biopsy or axillary lymph node dissection
- are aged > 18 years of age at the date of enrollment
- are willing to sign an informed consent form
Key exclusion criteria (5 listed)
- are male
- have had a bilateral axillary surgery
- do not undergo axillary evaluation
- are a minor
- cannot consider the issues involved in making an informed and autonomous decision.
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 |
|---|---|---|
| Garment Sleevecompression sleeve (20 to 30 mm of Hg) | Device | Intervention-garment sleeve, Observation |
Primary outcome
To determine whether early intervention in patients with pre-clinical lymphedema can halt the progression of lymphedema.
Time frame: 2 years
Evaluate whether a short trial of compression garments in women identified to have pre-clinical lymphedema can actually halt the progression of disease.
1 secondary outcome
200 women will have bioimpedance and volume displacement measurements to evaluate whether bioimpedance is an accurate, reliable method to measure pre-clinical and clinical lymphedema as compared to standard (volume displacement)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2012.
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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.
Andrea V Barrio, MD principal investigator
Bryn Mawr Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Garment Sleeve in people with Breast Cancer, run by Main Line Health at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 30 Jan 2012. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marita Truax, RN, BSN (484-337-8712, TruaxM@mlhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether early intervention in patients with pre-clinical lymphedema can halt the progression of lymphedema. (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 30 Jan 2012.