29 Clinical Trials for Lymphedema
Lymphedema affects millions and currently lacks effective drug treatments, relying mainly on compression therapy. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have shown potential in managing obesity and diabetes, which can worsen lymphedema. Although anecdotal evidence suggests benefits of GLP-1 RAs for lymphedema patients, rigorous prospective studies are lacking. This study aims to evaluate the effectiveness of GLP-1 RAs in improving quality of life and clinical outcomes in lymphedema patients, thereby addressing a critical gap in literature and potentially offering a new treatment option.
To learn if reconstruction of the lymphatic system at the time of axillary lymphadenectomy can reduce the risk of developing lymphedema.
The goal of this clinical trial in adult patients diagnosed with upper extremity lymphedema is to test the safety and effectiveness of small, wearable sensors that may be able to measure lymphedema. The main questions this study aims to answer are: * Do these sensors detect lymphedema? * If so, how accurate are these wearable sensors? Participants will complete one in-person measurement session and one phone call with study staff 14 days after the measurement session to check-in on the participant's well-being.
An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema
Lymphedema is a painful and disfiguring condition related to the buildup of protein-rich fluid in the body's tissues. The goal of this research study is to determine the safety and efficacy of a novel, proprietary device in the treatment of upper extremity lymphedema. This device has been previously studied on healthy people that do not have a diagnosis of lymphedema. It was found that using the device on them does not cause significant changes to their vital signs or level of pain. Side effects are reported sometimes; however, these are to be expected and are also frequently reported when people receive the standard of care for their lymphedema. Patients who have diagnosed lymphedema will be approached to participate in this study as part of their care. Participants will wear this device for approximately 40 minutes and then have certain measurements taken before and after doing so. These measurements include the size of their arm, how much pain/discomfort they are currently in, and if they experienced any side effects. After getting treatment with the device, they will receive the standard of care treatment for their lymphedema from their provider. After the standard of care has concluded, the previously mentioned measurements will be repeated. This data will be put together and analyzed to look for differences in arm size before and after treatment with the device as well as to look for the prevalence of side effects.
This clinical trial studies how well new adhesive-based sensors that stick to the skin (transcutaneous) work in detecting cancer-related long-term arm swelling (lymphedema). For many patients, lymphedema s painful, unsightly, and weakening. The early signs of lymphedema are hard to see, and sometimes it is only diagnosed by hospital equipment at larger centers. Treating lymphedema early is usually more successful than trying to treat in later stages. The adhesive-based sensors used in this study work by using techniques called photoplethysmography (PPG) and bioimpedance (BI). PPG is an optical technique that can be used to detect blood volume changes in tissue. BI evaluates how tissue responds to an externally applied electrical current. This study may assist researchers in distinguishing participants with lymphedema in comparison to participants without lymphedema, and develop a way for patients to check for lymphedema at home.
Chronic lymphedema in the lower extremities is a common problem found in older adults that can result in cellulitis, poor wound healing, venous stasis ulcers, and other comorbidities. Compressive therapies are the present gold standard for the manual treatment of lymphedema in the lower extremities. However, the benefits of these compressive therapies are modest, and they are not well tolerated by older adults. An alternative manual treatment is the osteopathic pedal pump, an osteopathic manipulative treatment, that uses a rhythmical pumping motion instead of compressive force to move interstitial fluid from the lower extremities back to the circulatory system. However, the evidence that the osteopathic pedal pump can reduce volume in the lower extremities remains anecdotal. The aim of this study is to determine if the osteopathic pedal pump can reduce volume in the lower extremities among older adults with chronic lymphedema. Leg volume will be measured using water displacement. Older adults with chronic lymphedema of the lower extremities will be randomly assigned to one of two groups: a treatment group that will receive one session of the osteopathic pedal pump and a control group that will receive one session of a light touch treatment.
The purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.
The goal of this study is to evaluate the effectiveness of a standardized lymphedema and fibrosis self-management program (LEF-SMP) to improve LEF self-management and reduce LEF-associated symptom burden, functional deficits, and improve quality of life in head and neck cancer (HNC) survivors.
To investigate whether the addition of Fibralign's BioBridge® Collagen Matrix (BioBridge) devices to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm.
The purpose of this study is to collect information that may identify people who are at risk of developing lower extremity lymphedema (LEL) after sentinel lymph node biopsy (SLN) during surgery for early-stage vulvar or cervical cancer, and to improve the quality and accuracy of the information that is given to people who have this procedure. Please note that, during this study, the researchers will collect information from a questionnaire completed by people who had SLN and LND+/- SLN during surgery for early-stage cervical or vulvar cancer. No form of treatment will be provided as part of the study, and no investigational tests or procedures will be performed.
This randomized clinical trial aims to compare clinic-based CDT and home-based (a hybrid model) CDT on changes in the severity of lymphedema, symptom burden, functional status, and healthcare utilization in HNC survivors with lymphedema.
To investigate whether the addition of Fibralign's BioBridge® Collagen Matrix (BioBridge) devices to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm.
This study is being done to see the long-term results for patients who choose to have surgery for lymphedema (with the vascularized lymph node transfer), compared to patients who choose not to have surgery.
This study is being done to find out how many women develop lymphedema after an axillary lymph node dissection. The investigators also want to look for reasons why some women get lymphedema and others don't. Specifically, the investigators want to do tests on the breast tissue that is removed at the time of surgery to see if they can identify inflammation in the breast tissue, which may increase a woman's risk for lymphedema. The investigators will also ask the patient to answer questions to see how much their quality of life is affected by lymphedema, and whether this study can help women by detecting lymphedema earlier.
The primary objectives of this study are twofold: 1) to detect and determine the level of symptoms, functional disability, and changes in quality of life that breast cancer patients experience from changes in their arms during and after treatment for breast cancer by collecting patient reported outcome measures, objective measurements, and clinical information in a prospectively maintained database and 2) to improve breast cancer-related lymphedema outcomes by early detection using objective measurements and symptoms assessments and assess these outcomes by maintaining the data in a database in order to contribute to the literature. The secondary aim of this study is to assess extracellular fluid content in the upper extremity, breast, and/or trunk of patients treated for breast cancer before, during, and after treatment in order to better understand the role of bioimpedance spectroscopy in lymphedema screening.
The purpose of the International Lymphatic Disease and Lymphedema Patient Registry and Biorepository is to collect health information in order to study the disease classification, natural history, and impact of Lymphatic Disease, Lymphedema and Related Disorders and its treatments and medical outcomes.
Breast cancer is the second most common cancer in women. One in five women who have been treated for breast cancer develop lymphedema. Lymphedema is a very common result of breast cancer and its treatment. Lymphedema is the build-up of fluid in tissues, which results in tissue swelling. The lymph system is a network of lymph vessels, tissues, and organs that carry extra fluid from your cells/tissues throughout the body. If this lymph fluid is not able to flow in the body how it should, there will be swelling which can lead to lymphedema. It can be classified into stages 0 to 3 depending on the severity of the condition. Stages 0 and 1 are reversible, and through early diagnosis and treatment, the recovery to the normal volume and normal skin status of arms can be possible. On the other hand, stage 2 or higher is irreversible, and tissue fibrosis progresses and cannot return to normal skin; therefore, it is important to detect early and start treatment. This is an observational longitudinal study. Potential participants will be recruited for follow-up after breast cancer surgery. Only patients who fit the inclusion criteria will be considered for participation in the study and contacted by the healthcare provider. Standard of care will be used to guide any treatment needed by participants while they are part of the study.
This study evaluates how swelling in the chest following breast cancer treatment may affect patients' quality of life and shoulder function.
The aim of this study is to test whether lymphatic surgery provides better QoL (assessed with the Lymph-ICF-UL, (Lymphedema Functioning Disability and health questionnaire for upper limb lymphedema)) 15 months after randomization (and therefore about one year after surgery) compared to conservative treatment only for patients with chronic lymphedema (LE)
This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes or melanoma. The lymphovenous bypass procedure creates a path for lymphatic fluid to flow away from the arms. It is usually done after a diagnosis of lymphedema. In this study, giving lymphovenous bypass before underarm lymph node surgery may help prevent lymphedema from forming.
To demonstrate that the Insight Pro Device is safe and effective for use in detecting lymphatic and venous disorders.
The purpose of this study is to determine whether the addition of simple hand mobility and grip strengthening exercises to the usual care for upper extremity lymphedema will reduce limb volume and improve the quality of life, hand dexterity, and grip strength for those experiencing breast cancer-related lymphedema. Researchers will compare those receiving the usual treatment to those receiving the usual treatment plus hand mobility and grip strengthening exercises.
This trial investigates a new approach using a mobile three-dimensional (3D) scanning application for volumetric measurement of the head and neck region in patients with head and neck lymphedema. Lymphedema is the buildup of extra lymph fluid in tissues that causes swelling. Accurate volumetric measurements of swelling are crucial to the diagnosis of lymphedema and to monitoring response to therapy and disease progression over time. A mobile 3D surface scanning application may help doctors measure and analyze swelling in patients with head and neck lymphedema.
This is a study of biomarkers obtained from prospectively collected subject samples and their correlation with cardiovascular and metabolic diseases. The purpose of this initiative is to develop an enduring tool to allow for collaborative research between clinicians at Cleveland Clinic Main Campus and basic scientists at the Lerner Research Institute. This collaboration will allow resources to be available to clinical and basic researchers alike. This tool will enable research of vascular disease in the Vascular Lab and will leverage this valuable asset to the fullest extent to allow for interdepartmental collaboration.
This real-world, observational registry captures structured data on chronic wounds and ulcers from 1,482 practitioners across all 50 U.S. states and Puerto Rico. Data are collected at the point of care through electronic health records (EHRs) or electronic data capture (EDC) systems and transmitted daily to the U.S. Wound Registry (USWR), a CMS-recognized Qualified Clinical Data Registry (QCDR). The registry supports quality improvement and comparative effectiveness research by providing insight into patient demographics, treatment patterns, and outcomes across a wide range of wound types and interventions.
The purpose of the study is to determine the recurrence rates and survival of patients with clinical T1-2N0 ER+/Her2- invasive breast cancer who have biopsy proven image detected nodal disease treated with upfront lumpectomy or mastectomy with TAD followed by adjuvant therapy. This is a prospective, single arm phase II clinical trial. Patients will be screened and enrolled per eligibility criteria. Patient, tumor, and treatment data will be documented.
Background: The lymphatic system is a network of vessels that carry a clear fluid called lymph through the body. Problems in the lymphatic system can cause pain, fluid buildup, and issues with immunity. There is much researchers do not understand about lymphatic anomalies. In this natural history study, they will collect data from a lot of people over a long time. Objective: To better understand why lymphatic anomalies develop. The goal is to improve future treatments. Eligibility: People aged 0 days and older with a suspected or confirmed lymphatic anomaly. Their unaffected parents or siblings aged 7 years or older are also needed. Design: Participants may remain in the study indefinitely. Affected participants may be evaluated every 10 months to 2 years. Some participants will be seen over telemedicine. Others will be seen at the NIH Clinical Center for 2-5 days. All participants will have a physical exam. They may provide specimens including blood, saliva, hair follicles, stool, skin, and other tissues. Samples may be used for genetic testing. Participants may undergo other tests depending on their medical conditions. The NIH Clinical Center visit may include: Heart tests include placing stickers on the chest to measure electrical activity and using sound waves to capture pictures of the heart. A lung test measures the muscle strength in the chest. Participants will blow into a tube. Photographs may be taken of participants faces and other features. Imaging scans will take pictures of the inside of the body. One scan will measure bone density. One type of scan tracks how lymph fluid moves through the body. Participants will be under anesthesia, and they will be injected with a dye.
Breast cancer is estimated to affect approximately 300,000 women in the US in 2023. Studies demonstrate that 1 in 5 will develop breast cancer related lymphedema secondary to the treatments that they receive. BCRL at this time has no cure, however early detection can prevent the progression to late stage BCRL. At this time a technique of arm massage, manual lymphatic drainage (MLD), is used for treatment. This study investigates a new method of MLD, which is guided by the individual patients' lymphatic anatomy through use of ICG-lymphography.