A Study Evaluating FT-SW in Unilateral Breast Cancer-Related Lymphedema Patients
NCT ID: NCT04073823
Last Updated: 2023-01-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
2 participants
INTERVENTIONAL
2020-01-23
2020-02-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study Evaluating Flexitouch Plus With Connectivity on Compliance in 30 Patients With Breast Cancer-Related Lymphedema.
NCT04432727
Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-risk Status
NCT00383500
Home-based Compression Therapy for Arm and Truncal Lymphedema in Breast Cancer
NCT00880022
Flexitouch Lymphedema System in Treating Stage II Lymphedema in Patients With Breast Cancer
NCT01019512
Treatment of Breast Cancer-related Lymphedema With a Negative Pressure Device
NCT03252145
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Flexitouch Plus
Flexitouch Plus
Flexitouch Plus full arm and core treatment
Flexitouch Plus with SW
Flexitouch Plus FT with software modification
Flexitouch Plus full arm and trunk/chest treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Flexitouch Plus
Flexitouch Plus full arm and core treatment
Flexitouch Plus FT with software modification
Flexitouch Plus full arm and trunk/chest treatment
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tactile Medical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
4070
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.