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48 active trials for Lymphedema

The Effect of Complex Decongestive Physiotherapy on Sensory Parameters in Breast Cancer Related Lymphedema.

The aim of this study was to determine the effect of complex decongestive physiotherapy in women with unilateral breast cancer-related lymphedema on sensory parameters.

Start: November 2019

Hypofractionated Loco-regional Adjuvant Radiation Therapy of Breast Cancer Combined With a Simultaneous Integrated Boost

The purpose of the study is to investigate the difference in late radiation morbidity between hypofractionated and normofractionated loco-regional breast irradiation irrespective of mastectomy or lumpectomy. In patients who a candidates for a boost, the boost will be provided as a simultaneous integrated boost.

Start: March 2015

Effect of Exercise on Indocyanine Green (ICG) Lymphography Imaging

Indocyanine Green (ICG) lymphography is a relatively new imaging technique that allows for quick visualization of superficial lymph flow in real-time, without radiation exposure. This imaging is useful for diagnosing and assessing lymphedema. ICG lymphography has a higher sensitivity and specificity than lymphoscintigraphy, the current gold standard imaging device for lymphedema. ICG lymphography precisely and reliably diagnoses, tracks, and stages lymphedema severity, ranging from subclinical or early lymphedema to more advanced cases. The ICG contrast dye used to visualize the lymphatic system takes approximately six hours to plateau. Therefore, patients must wait six hours between their initial and delayed scans. The purpose of this study is to determine if exercising on a Nu-step device between ICG initial and delayed scans would shorten the period of time a patient had to spend at the hospital on the day of their ICG lymphography. The general procedures for this involve (after selecting subjects, consenting subjects, educating the subject on the protocol, along with other appropriate measures): Taking baseline vitals (HR & SpO2) and limb circumference measurements 5-minute period of time to acquaint subject with the exercise equipment (Nu-Step) at any level of exertion injection of contrast agent to allow for visualization of the superficial lymphatic system by a qualified nurse Initial scan A 5-minute period of exercise at "moderate" level of exercise (This correlates to the rating of perceived exertion levels of 12-13; All exercise periods should be at this level and will be monitored by a provider) Second scan & vitals 5-minute period of exercise Third scan & vitals o Continue 5-minute exercise period followed by scan & vitals until disease pattern emerges * Exercise for 5 minutes then scan and vitals until images reach steady state for two consecutive scans Final vitals (HR & SpO2) * Repeat scan every 1 hour until the normal 6 hour scan to monitor for further changes in lymphatic pattern. Exit survey

Start: April 2019

Characterization of Treatment Responses in Lymphedema

This study is designed to investigate the treatment response of lymphedema, of the upper or lower extremity, during clinical, pharmacologic treatment of lymphedema with oral ketoprofen. Correlation of clinical responses (changes in limb volume and skin thickness) with changes in the inflammasome will help to define the molecular substrate of treatment response.

Start: June 2019

Microsurgical Treatment of Breast Cancer-related Lymphedema by Lymphaticovenous Anastomosis

Research question: Is lymphaticovenous anastomosis (LVA) for the treatment of breast cancer-related lymphedema of the arm (BCRL) more effective and cost-effective compared to standard conservative treatment? Hypothesis: LVA improves the health-related quality of life of patients who developed BCRL after breast cancer treatment and is cost-effective compared to conservative treatment. Study design: A multicenter randomised controlled trial (RCT) consisting of two treatment groups: conservative treatment (group A) and LVA (group B). The study is conducted in Maastricht University Medical Center, Radboud University Medical Center, Zuyderland Medical Center and Canisius-Wilhelmina Hospital. Study population: Women over 18 years old who underwent (axillary) treatment for breast cancer presenting with early stage lymphedema of the arm for which they received at least three months conservative treatment Intervention: LVA involves anastomosing lymphatic vessels to small veins to bypass obstructions in the lymphatic system. Usual care: Complex decongestive therapy (CDT) which includes skin care, manual lymphatic drainage, and compression therapy. Outcome measures: The primary outcome is health-related quality of life after 12 months follow-up measured with the Lymph-ICF questionnaire. Secondary outcomes are (in)direct costs, QALYs, cost-effectiveness ratio, the discontinuation rate of conservative treatment, and excess limb volume. Sample size: A total of 120 patients will be included and randomised in two groups of 60 patients each. Cost-effectiveness analysis: A trial-based economic evaluation is performed from the societal perspective to determine the cost-effectiveness, expressed in an incremental cost-effectiveness ratio (ICER) (i.e. cost per QALY gained), of LVA compared to CDT. Direct and indirect cost data is collected on the patient-level. The difference in QALYs is assessed with the EQ-5D-5L questionnaire. A Budget Impact Analysis (BIA) will be performed to analyse the financial consequences related to implementing LVA. Time schedule: Patient inclusion will take maximally 21 months. With a follow-up of 24 months, the total study period will be 48 months. The last three months are used for data analysis. Outcome assessment is at inclusion (before randomisation) and 3, 6, 12, 18, and 24 months later.

Start: January 2019

Sentinel Node Detection in Endometrial Cancer: A Consolidation Study on Detection Rates of Metastatic Disease

Evaluation of removal of Sentinel lymph nodes only for detection of pelvic lymph node metastases in high risk and low risk endometrial cancer.

Start: February 2019

A Real World, Observational Registry of Chronic Wounds and Ulcers

More than 100 hospital based outpatient wound centers in the USA and Puerto Rico agree to transmit structured data on all patients followed with chronic wounds and ulcers (e.g. diabetic foot ulcers, venous ulcers, pressure ulcers, arterial ulcers, surgical wounds, and traumatic wounds). Data are collected at point of care including adherence to wound care quality measures developed by the USWR as a Qualified Clinical Data Registry (QCDR).

Start: January 2005

Histologic Analysis of the Lymphatic Vessels Used for Supermicrosurgical Lymphatico-venous Anastomoses in Lymphedema

Lymphedema, primary or secondary, is a chronic disease that causes functional impairment and has an important impact on patient's quality of life. Lymphedema can be primary or secondary. Secondary lymphedema, which is more common, especially in industrialized countries, is often due to surgery and radiotherapy to treat cancer. There is no definite cure for lymphedema; conservative treatments such as elastic compression garments, bandages and manual lymphatic drainage help reducing the edema but do not resolve it. Many types of surgery have been used in the past, the most recent are lymphatic-venous anastomoses, a minimally invasive procedure that may be performed under local anesthesia. Briefly, after visualizing the lymphatic vessels with a fluorescent dye, one or more anastomosis are created between collecting lymphatic vessels and superficial veins in order to drain the lymph into the blood stream bypassing the obstacle. During this procedure, it is possible to take samples of the collecting lymphatic vessels that are to be anastomosed with veins and use them for histological and immunohistochemical studies, without causing any additional discomfort to the patient. These samples can be formalin fixed and paraffin embedded. The obtained sections will be stained with a lymphatic endothelium marker and a smooth muscle specific stain. A morphometric study will be conducted and, based on the results a statistical evaluation will be made. The analysis will be conducted on samples obtained from patients, affected by secondary or primary lymphedema willing to provide their free and informed consent. The aim of this study is to evaluate the histopathological characteristics of the collecting lymphatic vessels that have been anastomosed with adjacent veins during surgery, and relate the results with the obtained clinical response. The acquired knowledge will contribute to optimize the clinical approach to prevent and treat lymphedema, by helping to select the patients that will benefit more from the surgery, and to select vessels and anatomical sites that have better chances to provide efficient anastomoses.

Start: June 2017