LymphedemaNCT03648983
Arm Circumference Measurement With or Without Bioimpedance Spectroscopy in Finding Lymphedema Early in Patients With Stage I-III Breast Cancer
A study testing arm circumference measurement and Bioimpedance spectroscopy in people with Lymphedema and Breast Cancer, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
This randomized pilot clinical trial studies arm circumference measurement with or without bioimpedance spectroscopy in finding extra lymph node fluid build up in the arm (lymphedema) early in patients with stage I-III breast cancer undergoing lymph node dissection or sentinel node biopsy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Lymphedema, Breast Cancer
- What is being tested?
- arm circumference measurement and Bioimpedance spectroscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed with stage I-III cancer of the female breast
- Patients scheduled to receive any type of radiation therapy to the breast or axilla are eligible; however, they must be registered to this study with pre-surgery measures taken prior to receiving neoadjuvant therapy as well as before surgery
- Patients scheduled to receive neoadjuvant chemotherapy are also eligible; however, they must be registered to this study with pre-surgery measurements taken prior to receiving neoadjuvant therapy as well as before surgery
- Patients with a history of other invasive malignancies are eligible as long as they have no evidence of disease 5 years post-diagnosis
- Patients with basal cell and squamous cell cancer of the skin are eligible
- Patients willing to return to the study site for the duration of the study (34 months)
Who cannot join
- Pregnant women
- Patients who are homebound or dependent upon a walker or wheelchair for mobility
- Patients diagnosed enhanced lymphedema
- Hypertensive patients who are using diuretics
- Documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease which, in the opinion of the treating physician, significantly increases mortality over the next 2 years
- Prior history of carcinoma in situ, lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), or invasive breast cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: A Pilot Randomized Trial Comparing Arm Circumference and Bioimpedance Measurement for Early Detection and Treatment of Lymphedema in Patients Undergoing Axillary Lymph Node Dissection or Sentinel Node Biopsy
This randomized pilot clinical trial studies arm circumference measurement with or without bioimpedance spectroscopy in finding extra lymph node fluid build up in the arm (lymphedema) early in patients with stage I-III breast cancer undergoing lymph node dissection or sentinel node biopsy. Diagnostic procedures, such as bioimpedance spectroscopy, may allow doctors to find and diagnose lymphedema earlier than arm circumference measurement alone.
Read the detailed description
PRIMARY OBJECTIVES:
- To test, in a randomized controlled trial, the ability of the enhanced lymphedema (LE) detection program (ELED) versus arm circumference alone to detect early/reversible LE.
II. To compare the severity of LE in terms of changes in arm circumference at the site of greatest difference and L-Dex change, between the two detection modalities.
III. To assess the agreement between patients' self-report of swelling (mild, moderation and severe) and the extent of circumferential measurement/bioimpedance spectroscopy (BIS) difference.
IV. To compare the percentage of subjects with complete resolution of signs and symptoms of LE following treatment with a compression garment between the enhanced vs. standard detection groups.
- To determine compliance with LE preventive care and treatment.
Patients are randomized to 1 of 2 arms: those undergo arm circumference measurement only and those undergoing undergo arm circumference measurement and bioimpedance spectroscopy. Measurements taken at 4, 10, 16, 22, 28, and 34 months.
In both arms, if lymphedema is diagnosed, patients are given a compression garment to wear daily for 6 weeks. If lymphedema does not improve after 6 weeks, patients undergo complete decongestive therapy over approximately 1 hour three times a week. Patients complete remedial exercises comprising active, repetitive range of motion of the involved extremity and light aerobic conditioning until extremity volume stabilizes or improves. Patients are also instructed to perform exercises at home.
After completion of study, patients diagnosed with lymphedema are followed up for 1 year.
- Conditions
- Lymphedema, Breast Cancer
- Being tested
- arm circumference measurement, Bioimpedance spectroscopy
- Keywords
- Enhanced Lymphedema
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arm circumference measurementProcedure or surgery
Undergo arm circumference measurement
Bioimpedance spectroscopyDevice
Also called BIS
bioimpedance spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| Standard LE detection | Active comparator | Arm measurements taken. Patients undergo arm circumference measurement at 4, 10, 16, 22, 28, and 34 months. Receives: Procedure: arm circumference measurement |
| Enhanced LE detection | Experimental | Bioimpedance spectroscopy used along with arm measurements. Patients undergo arm circumference measurement and bioimpedance spectroscopy at 4, 10, 16, 22, 28, and 34 months. Receives: Procedure: arm circumference measurement; Device: Bioimpedance spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of Enhanced Lymphedema Detection
Rates of enhanced lymphedema detection will be compared between the enhanced versus standard detection groups with the Fisher's exact test. Adjustment for potential imbalances in patient characteristics will be accomplished by fitting logistic and Cox proportional hazards regression models.
- Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.*
Measured: During treatment (Up to 34 months)
Secondary outcomes (2)
Severity of Enhanced Lymphedema
Severity of LE in terms of changes in arm circumference at the site of greatest difference and L-Dex change, will be compared between the enhanced versus standard detection groups with the Fisher's exact test. Adjustment for potential imbalances in patient characteristics will be accomplished by fitting logistic and Cox proportional hazards regression models.
Measured: During treatment (Up to 34 months)
Percentage of Subjects With Complete Resolution of Signs of Enhanced Lymphedema
The Fisher's exact test will be used to compare between the enhanced vs. standard detection groups the percentage of subjects with complete resolution of signs and symptoms of LE following treatment with a compression garment. Logistic regression models will also be fit to the data to adjust for potential confounders.
Measured: During treatment (up to 34 months) plus 1 year post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study startNov 2011
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Pi departure; service discontinued study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lisa Wiechmann, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648983
- Sponsor's protocol ID
- 11-06-235
- Other IDs
- NCI-2014-01480, 11-06-235E, 11-047, LDEX, P30CA013330
- Status last verified
- Aug 2018
- First submitted
- 8 Oct 2015
- Last updated
- 1 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Trial Comparing Arm Circumference and Bioimpedance Measurement for Early Detection and Treatment of Lymphedema in Patients Undergoing Axillary Lymph Node Dissection or Sentinel Node Biopsy
- ClinicalTrials.gov ID
- NCT03648983
- Acronym / sponsor ID
- 11-06-235
- Conditions
- Lymphedema, Breast Cancer
- Keywords
- Enhanced Lymphedema
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pi departure; service discontinued study
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 28 Aug 2018 (actual)
- Results
- Posted 1 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized pilot clinical trial studies arm circumference measurement with or without bioimpedance spectroscopy in finding extra lymph node fluid build up in the arm (lymphedema) early in patients with stage I-III breast cancer undergoing lymph node dissection or sentinel node biopsy. Diagnostic procedures, such as bioimpedance spectroscopy, may allow doctors to find and diagnose lymphedema earlier than arm circumference measurement alone.
Detailed description
PRIMARY OBJECTIVES:
- To test, in a randomized controlled trial, the ability of the enhanced lymphedema (LE) detection program (ELED) versus arm circumference alone to detect early/reversible LE.
II. To compare the severity of LE in terms of changes in arm circumference at the site of greatest difference and L-Dex change, between the two detection modalities.
III. To assess the agreement between patients' self-report of swelling (mild, moderation and severe) and the extent of circumferential measurement/bioimpedance spectroscopy (BIS) difference.
IV. To compare the percentage of subjects with complete resolution of signs and symptoms of LE following treatment with a compression garment between the enhanced vs. standard detection groups.
- To determine compliance with LE preventive care and treatment.
Patients are randomized to 1 of 2 arms: those undergo arm circumference measurement only and those undergoing undergo arm circumference measurement and bioimpedance spectroscopy. Measurements taken at 4, 10, 16, 22, 28, and 34 months.
In both arms, if lymphedema is diagnosed, patients are given a compression garment to wear daily for 6 weeks. If lymphedema does not improve after 6 weeks, patients undergo complete decongestive therapy over approximately 1 hour three times a week. Patients complete remedial exercises comprising active, repetitive range of motion of the involved extremity and light aerobic conditioning until extremity volume stabilizes or improves. Patients are also instructed to perform exercises at home.
After completion of study, patients diagnosed with lymphedema are followed up for 1 year.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard LE detection | Active comparator | Procedure: arm circumference measurementArm measurements taken. Patients undergo arm circumference measurement at 4, 10, 16, 22, 28, and 34 months. |
| Enhanced LE detection | Experimental | Procedure: arm circumference measurement, Device: Bioimpedance spectroscopyBioimpedance spectroscopy used along with arm measurements. Patients undergo arm circumference measurement and bioimpedance spectroscopy at 4, 10, 16, 22, 28, and 34 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Newly diagnosed with stage I-III cancer of the female breast
- Patients scheduled to receive any type of radiation therapy to the breast or axilla are eligible; however, they must be registered to this study with pre-surgery measures taken prior to receiving neoadjuvant therapy as well as before surgery
- Patients scheduled to receive neoadjuvant chemotherapy are also eligible; however, they must be registered to this study with pre-surgery measurements taken prior to receiving neoadjuvant therapy as well as before surgery
- Patients with a history of other invasive malignancies are eligible as long as they have no evidence of disease 5 years post-diagnosis
- Patients with basal cell and squamous cell cancer of the skin are eligible
Key exclusion criteria (6 listed)
- Pregnant women
- Patients who are homebound or dependent upon a walker or wheelchair for mobility
- Patients diagnosed enhanced lymphedema
- Hypertensive patients who are using diuretics
- Documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease which, in the opinion of the treating physician, significantly increases mortality over the next 2 years
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 |
|---|---|---|
| arm circumference measurementUndergo arm circumference measurement | Procedure or surgery | Enhanced LE detection, Standard LE detection |
| Bioimpedance spectroscopyAlso: BISbioimpedance spectroscopy | Device | Enhanced LE detection |
Primary outcome
Rates of Enhanced Lymphedema Detection
Time frame: During treatment (Up to 34 months)
Rates of enhanced lymphedema detection will be compared between the enhanced versus standard detection groups with the Fisher's exact test. Adjustment for potential imbalances in patient characteristics will be accomplished by fitting logistic and Cox proportional hazards regression models. * Study was terminated because PI left the institution. Study coordinator also left the institution. No data was analyzed. Participants' baseline records not available.*
2 secondary outcomes
Severity of Enhanced Lymphedema
Time frame: During treatment (Up to 34 months)
Percentage of Subjects With Complete Resolution of Signs of Enhanced Lymphedema
Time frame: During treatment (up to 34 months) plus 1 year post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Lymphedema
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
Recruiting
Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer
Lymphedema Arm
RecruitingObservational study
A Prospective Natural History Study of Lymphatic Anomalies
Lymphatic Diseases, Lymphatic Abnormalities
RecruitingObservational study
Use of Reconstructive Microsurgery for the Treatment of Lymphedema
Lymphedema
Recruiting
The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
Lymphedema, Breast Cancer
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.
Lisa Wiechmann principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arm circumference measurement and Bioimpedance spectroscopy in people with Lymphedema and Breast Cancer, run by Albert Einstein College of Medicine 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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 1 Oct 2018. 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?
Yes. Results are posted in the registry (first posted 1 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rates of Enhanced Lymphedema Detection (time frame: During treatment (Up to 34 months)). 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 1 Oct 2018.