LymphedemaNCT00383500
Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status
A study testing Flexitouch and Class 1 compression garment in people with Lymphedema and Breast Cancer, run by Stanford University at 1 site in United States.
Trial summary
To compare the effectiveness of usual treatments for lymphedema [massage and elastic compression sleeve, instituted at-risk and before the development of swelling (lymphedema)], compared to the use of a newly-marketed device, the Flexitouch, which electronically simulates the effect of massage upon lymph flow. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema, Breast Cancer
- What is being tested?
- Flexitouch and Class 1 compression garment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Sep 2009
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral breast cancer
- Scheduled to undergo breast surgery and axillary lymph node dissection, with or without breast conserving techniques.
- Referred to the surgeons of the Stanford University Breast Cancer Program
- Capacity to provide informed consent.
- All experimental protocols will be reviewed and approved by the Stanford Institutional Review Board for the Protection of Human Subjects.
Who cannot join
- Other serious systemic illness (renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would confound the study or impair the patients' ability to participate.
- Recurrent breast cancer or other forms of pre-existing lymphedema.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: To Prospectively Evaluate the Potential for Simple, Effective Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status
To compare the effectiveness of usual treatments for lymphedema [massage and elastic compression sleeve, instituted at-risk and before the development of swelling (lymphedema)], compared to the use of a newly-marketed device, the Flexitouch, which electronically simulates the effect of massage upon lymph flow.
Read the detailed description
The current investigation is designed to prospectively evaluate the potential for simple, effective lymphedema prophylaxis in breast cancer survivors who show early evidence of high-risk status. There is growing evidence that the mechanisms of lymphatic repair after injury are mediated through lymphatic flow. Accordingly, this study assess if physical measures designed to prophylactically augment lymphatic flow after surgical interventions for breast cancer (eg, Flexitouch and manual lymphatic massage) will reduce the incidence of lymphatic stagnation, assessed as incidence of lymphedema, when compared to patients who receive conventional "watch and wait" interventions (observation).
The specific aims of the study are
- to prospectively assess the presence of newly developing lymphedema in each study subgroup through serial assessment of segmental interstitial fluid content by multiple frequency bioimpedance
- to evaluate the preventive interventions in a prospective, randomized fashion, contrasting the responses of equivalent numbers of patients randomized to 2 experimental arms and the control arm of the study
- to correlate the bioimpedance findings with concurrently derived, serial assessments of limb volume
Recent advances in the medical understanding of the biological processes of lymphatic development and repair suggest that these mechanisms may be able to be manipulated to enhance the regenerative responses in the lymphatic vasculature following injury. Breast cancer-associated lymphedema is a model of such an acquired form of lymphatic vasculature insufficiency. Clinically, this poses a substantial clinical problem. It is estimated at 1woman in 4 who survives a breast cancer intervention will develop lymphedema, often progressively. The appearance of lymphedema has documented adverse effects on physical and psychologically well-being. New insights into lymphatic repair suggest that such mechanisms can be employed in a prophylactic fashion to forestall or eliminate the development of lymphedema. This proposal investigates this hypothesis in a prospective fashion, using a randomized trial design in 80 patients enrolled at the time of breast cancer surgery. If the investigation documents a beneficial effect of preventive measures, it could have a profound impact on subsequent breast cancer care. These measures are simple and cost-effective and, could help to eliminate the impact of a substantial detractor to the improved longevity and health that breast cancer survivors otherwise may expect to enjoy.
- Conditions
- Lymphedema, Breast Cancer
- Being tested
- Flexitouch, Class 1 compression garment
- 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.
FlexitouchDevice
Also called Tactile Systems Technology, Inc., Biocompression, Lymphatic massage therapy
A standard of care intermittent pneumatic compression device (aka, lymphedema pump)
Class 1 compression garmentDevice
Also called Manual lymphatic drainage, Lymphatic massage therapy
Manual lymphatic drainage therapy to provide lymphatic massage, using a Class 1 compression garment supporting the arm during heavy exercise or where the risk of trauma maybe increased (ie, flight, elevation, etc).
| Study group | Role | What they receive |
|---|---|---|
| Flexitouch device | Experimental | Participants will self-administer lymphedema management via daily use of the Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump) Receives: Device: Flexitouch |
| Manual Lymphatic Drainage (MLD) | Experimental | Participants will self-administer lymphedema management via daily manual lymphatic massage therapy, using a Class 1 compression garment Receives: Device: Class 1 compression garment |
| Observational Control (no intervention) | No intervention | Control group, no intervention. No Flexitouch or manual massage therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Assessment of Lymphedema by Multiple Frequency Bioimpedance Spectroscopy
Successful, serial multiple frequency bioimpedance assessment for newly developing lymphedema in the 3 study groups
Measured: 36 months
Incidence of Lymphedema (Newly-developing)
Incidence of newly-developing lymphedema for each study cohort, as detected by serial multiple frequency bioimpedance spectroscopy scans for increased interstitial fluid within regional tissues.
Measured: 3 years of semi-annual follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2006 (estimated)
- Study startMay 2005
- Primary completionJul 2009
- Study completionSep 2009
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.
- More trials run by Stanford UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanley Rockson, Stanford University
- Investigators
- Stanley G Rockson, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383500
- Sponsor's protocol ID
- IRB-01671
- Other IDs
- 95970, BRSNSTU0007
- Status last verified
- Feb 2017
- First submitted
- 29 Sep 2006
- Last updated
- 30 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: undecided at this time.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Prospectively Evaluate the Potential for Simple, Effective Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status
- ClinicalTrials.gov ID
- NCT00383500
- Acronym / sponsor ID
- IRB-01671
- Conditions
- Lymphedema, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 3 Oct 2006 (estimated)
- Results
- Posted 30 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effectiveness of usual treatments for lymphedema [massage and elastic compression sleeve, instituted at-risk and before the development of swelling (lymphedema)], compared to the use of a newly-marketed device, the Flexitouch, which electronically simulates the effect of massage upon lymph flow.
Detailed description
The current investigation is designed to prospectively evaluate the potential for simple, effective lymphedema prophylaxis in breast cancer survivors who show early evidence of high-risk status. There is growing evidence that the mechanisms of lymphatic repair after injury are mediated through lymphatic flow. Accordingly, this study assess if physical measures designed to prophylactically augment lymphatic flow after surgical interventions for breast cancer (eg, Flexitouch and manual lymphatic massage) will reduce the incidence of lymphatic stagnation, assessed as incidence of lymphedema, when compared to patients who receive conventional "watch and wait" interventions (observation).
The specific aims of the study are
- to prospectively assess the presence of newly developing lymphedema in each study subgroup through serial assessment of segmental interstitial fluid content by multiple frequency bioimpedance
- to evaluate the preventive interventions in a prospective, randomized fashion, contrasting the responses of equivalent numbers of patients randomized to 2 experimental arms and the control arm of the study
- to correlate the bioimpedance findings with concurrently derived, serial assessments of limb volume
Recent advances in the medical understanding of the biological processes of lymphatic development and repair suggest that these mechanisms may be able to be manipulated to enhance the regenerative responses in the lymphatic vasculature following injury. Breast cancer-associated lymphedema is a model of such an acquired form of lymphatic vasculature insufficiency. Clinically, this poses a substantial clinical problem. It is estimated at 1woman in 4 who survives a breast cancer intervention will develop lymphedema, often progressively. The appearance of lymphedema has documented adverse effects on physical and psychologically well-being. New insights into lymphatic repair suggest that such mechanisms can be employed in a prophylactic fashion to forestall or eliminate the development of lymphedema. This proposal investigates this hypothesis in a prospective fashion, using a randomized trial design in 80 patients enrolled at the time of breast cancer surgery. If the investigation documents a beneficial effect of preventive measures, it could have a profound impact on subsequent breast cancer care. These measures are simple and cost-effective and, could help to eliminate the impact of a substantial detractor to the improved longevity and health that breast cancer survivors otherwise may expect to enjoy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Flexitouch device | Experimental | Device: FlexitouchParticipants will self-administer lymphedema management via daily use of the Flexitouch device, an intermittent pneumatic compression device (aka, lymphedema pump) |
| Manual Lymphatic Drainage (MLD) | Experimental | Device: Class 1 compression garmentParticipants will self-administer lymphedema management via daily manual lymphatic massage therapy, using a Class 1 compression garment |
| Observational Control (no intervention) | No intervention | –Control group, no intervention. No Flexitouch or manual massage therapy |
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)
- Unilateral breast cancer
- Scheduled to undergo breast surgery and axillary lymph node dissection, with or without breast conserving techniques.
- Referred to the surgeons of the Stanford University Breast Cancer Program
- Capacity to provide informed consent.
- All experimental protocols will be reviewed and approved by the Stanford Institutional Review Board for the Protection of Human Subjects.
Key exclusion criteria (2 listed)
- Other serious systemic illness (renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would confound the study or impair the patients' ability to participate.
- Recurrent breast cancer or other forms of pre-existing lymphedema.
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 |
|---|---|---|
| FlexitouchAlso: Tactile Systems Technology, Inc., Biocompression, Lymphatic massage therapyA standard of care intermittent pneumatic compression device (aka, lymphedema pump) | Device | Flexitouch device |
| Class 1 compression garmentAlso: Manual lymphatic drainage, Lymphatic massage therapyManual lymphatic drainage therapy to provide lymphatic massage, using a Class 1 compression garment supporting the arm during heavy exercise or where the risk of trauma maybe increased (ie, flight, elevation, etc). | Device | Manual Lymphatic Drainage (MLD) |
Primary outcome
Number of Participants With Successful Assessment of Lymphedema by Multiple Frequency Bioimpedance Spectroscopy
Time frame: 36 months
Successful, serial multiple frequency bioimpedance assessment for newly developing lymphedema in the 3 study groups
Incidence of Lymphedema (Newly-developing)
Time frame: 3 years of semi-annual follow-up
Incidence of newly-developing lymphedema for each study cohort, as detected by serial multiple frequency bioimpedance spectroscopy scans for increased interstitial fluid within regional tissues.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. undecided at this time.
Related trials for Lymphedema
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
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.
Stanley G Rockson principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexitouch and Class 1 compression garment in people with Lymphedema and Breast Cancer, run by Stanford University 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 2 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 30 Mar 2017. 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 30 Mar 2017). 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?
Number of Participants With Successful Assessment of Lymphedema by Multiple Frequency Bioimpedance Spectroscopy (time frame: 36 months). 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 30 Mar 2017.