A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients (NCT04073823) | Clinical Trial Compass
TerminatedNot Applicable
A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients
Stopped: Due to unforeseen slow enrollment and a shift in corporate resources due to the COVID-19 impact.
United States2 participantsStarted 2020-01-23
Plain-language summary
The objective of the study is to demonstrate equivalency in treatment effect, as determined by objective measurements, between the modified therapy cycle software and the FDA-cleared Flexitouch therapy cycle software.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female 18 years of age or older
* Diagnosis of unilateral breast cancer-related lymphedema
* Stage I or early stage II lymphedema without severe fibrosis at the time of enrollment
* ≥ 5% volume difference between affected and unaffected arm as verified via perometry
* Willing and able to give informed consent
* Willing and able to comply with the study protocol requirements and all study-related visit requirements
Exclusion Criteria:
* In-home use of PCD within previous 3 months
* Therapist or self-administered manual lymph drainage (MLD) within previous 1 week
* Mastectomy or lymph node removal on side without lymphedema
* Bilateral lymphedema
* Heart failure (acute pulmonary edema, decompensated acute heart failure)
* Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
* Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the arms or trunk
* Active cancer (cancer that is currently under treatment, but not yet in remission)
* Poorly controlled kidney disease (glomerular filtration rate \< 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism, cyclic edema, or Munchausen Syndrome
* BMI \>50
* Any circumstance where increased lymphatic or venous return is undesirable
* Currently pregnant or trying to become pregnant
* Allergy to iodine
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lymphatic Activation
Timeframe: Baseline and following a single treatment, an average of one hour
2
Changes in Swelling - MoistureMeterD
Timeframe: Baseline and following a single treatment, an average of one hour
3
Changes in Swelling - Perometry
Timeframe: Baseline and following a single treatment, an average of one hour
4
Percent Change in Skin Thickness From Baseline to After Treatment.
Timeframe: Baseline and following a single treatment, an average of one hour
5
Incidence of Adverse Events
Timeframe: 24-Hour Follow-Up
6
Post-Treatment Functional Vessel Assessment Via Near Infrared-fluorescent (NIRF) Imaging
Timeframe: Baseline and following a single treatment, an average of one hour
7
Projected Area or Extent of Dermal Backflow Via Near Infrared-fluorescent (NIRF) Imaging