Clinical Trials Logo

Lymphedema clinical trials

View clinical trials related to Lymphedema.

Filter by:

NCT ID: NCT02929121 Completed - Lymphedema Clinical Trials

A 24 Month Study to Compare Efficacy of Doxycycline vs Placebo for Improving Filarial Lymphedema in India

LeDoxy-India
Start date: January 15, 2019
Phase: Phase 3
Study type: Interventional

Current lymphedema management protocols are based on the use of simple measures of hygiene (regular washing with soap and water, skin and nail care), use of topical antibiotics or antifungal agents, exercise and footwear. This is considered the "standard of care" in most endemic countries in the absence of any structured treatment programs. Previous controlled clinical trials and extensive field experience have shown the benefit of these measures in reducing the frequency of attacks of acute dermato-lymphangio-adenitis (ADLA) that drive the progression of lymphedema. In the present study, the progression of lymphedema in a group of patients who receive a six-week course of doxycycline will be compared with that of a group who receives doxycycline "look-alike" placebo tablets. However, both groups will be enrolled into a standardized "regimen of hygiene" described above. Thus, patients enrolled in the "placebo" group also will receive the current standard of care, and the placebo used in the study will help to identify the benefits of doxycycline on a background of simple hygiene measures. The regimens will be explained to all participants who will be trained to use established standardized methods of hygiene and be effectively applying it prior to the initiation of the drug treatment. In addition, patients will be evaluated at 3, 6, 12 and 24 months.. A common, generic SOP with handouts that describes methods and the training schedule will be used so that similar methods are employed across all sites.

NCT ID: NCT02927496 Completed - Lymphedema Clinical Trials

A 24 Month Study, to Compare the Efficacy of Doxycycline vs. Placebo for Improving Filarial Lymphedema in Mali

LeDoxy-Mali
Start date: June 19, 2018
Phase: Phase 3
Study type: Interventional

Current lymphedema management protocols are based on the use of simple measures of hygiene (regular washing with soap and water, skin and nail care), use of topical antibiotics or antifungal agents, exercise and footwear. This is considered the "standard of care" in most endemic countries in the absence of any structured treatment programs. Previous controlled clinical trials and extensive field experience have shown the benefit of these measures in reducing the frequency of attacks of acute dermato-lymphangio-adenitis (ADLA) that drive the progression of lymphedema. In the present study, the progression of lymphedema in a group of patients who receive a six-week course of doxycycline will be compared with that of a group who receives doxycycline "look-alike" placebo tablets. However, both groups will be enrolled into a standardized "regimen of hygiene" described above. Thus, patients enrolled in the "placebo" group also will receive the current standard of care, and the placebo used in the study will help to identify the benefits of doxycycline on a background of simple hygiene measures. The regimens will be explained to all participants who will be trained to use established standardized methods of hygiene and be effectively applying it prior to the initiation of the drug treatment. In addition, patients will be evaluated at 3, 6, 12 and 24 months.. A common, generic SOP with handouts that describes methods and the training schedule will be used so that similar methods are employed across all sites.

NCT ID: NCT02912767 Completed - Endometrial Cancer Clinical Trials

Prevalence of Self Reported Lymphedema in Patients With Endometrial Cancer

Start date: July 20, 2016
Phase:
Study type: Observational

The investigators are interested in understanding how the patient has been doing since their surgery for endometrial cancer and if they are experiencing any symptoms related to lymphedema (swelling) in the your lower body. The investigators hope that information from the patient and others will help them improve care for women treated for endometrial cancer.

NCT ID: NCT02857621 Completed - Lymphedema Clinical Trials

Evaluation of Pressure Applying Efficiency in Multi-Layer Bandaging

Start date: August 2016
Phase: N/A
Study type: Observational

Lymphedema is a condition characterized by excess accumulation of protein rich tissue fluid in interstitial spaces. It is a progressive chronic disease and without appropriate management may result in serious complications. In Israel, patients are referred to physiotherapists certified in treatment for lymphedema. According to the International Society of Lymphology (ISL) the best treatment is a holistic, multidiscipline approach. Amongst the different methods of lymphedema management, the use of compression is the only treatment that has shown to be effective in randomized controlled trials. The ISL recommends that patients with lymphedema in the lower limb ought to bandage their leg with multi-layer bandaging on a daily basis for a period of two to four weeks. A new classification system for compression bandages was recommended; pressure of <20 mmHg was categorized as mild, 20-40 mmHg as medium, 40-60 mmHg as strong and ≥60 mmHg as very strong. In patients with leg edema, bandages with strong pressure were shown to be the most effective. However, in the presence of a venous ulcer on a lymphatic leg, pressure between 35 and 45 mmHg is the widely accepted range for sufficient and safe compression. The use of measurement instruments is currently the only realistic method for determining the actual pressure achieved beneath the bandage. However, it is neither economical nor feasib¬le nor is it realistic in terms of time. Recent studies show that many healthcare professionals use inadequate sub-bandage pressure. No study so far has focused on therapists that are trained in lymphatic treatment. In spite of correct pressure bandaging importance, the question whether physiotherapists succeed in correctly applying it is left unanswered. The main purpose of this study is to evaluate the pressure applying efficiency in multi-layer bandaging among physiotherapists in Israel who treat lymphedema. 34 physiotherapists trained in lymphatic treatment will be recruited for this research. Each volunteer will receive a questionnaire concerning their self-perceived competence in the application of compression bandages. Afterwards, two practical trials will be held a week apart in which the subjects will be asked to apply bandages using strong and medium pressure. Using PicoPress®, pressure will be measured directly after bandaging and two hours later. Our hypothesis is that the majority of therapists will properly apply medium or strong pressure on the lower limbs.

NCT ID: NCT02752659 Completed - Breast Cancer Clinical Trials

Reliability and Validity of Self-measured Arm Circumference in Women With Breast Cancer

Start date: June 2016
Phase: N/A
Study type: Interventional

Early detection and treatment of onset or worsening of breast cancer-related lymphedema (BCRL) can potentially prevent or postpone the condition to progress into a chronic progressive condition or eliminate the risk of infections in the arm (cellulitis). Self-surveillance for BCRL by routinely measuring own arm circumference could potentially enable early detection of onset or worsening of lymphedema. The aim is to determine whether women who have received surgery for breast cancer, can perform self-measures of arm circumference in a reliable and valid manner using written and video supported instructions without in-person teaching by a physiotherapist.

NCT ID: NCT02734979 Completed - Lymphedema Clinical Trials

Prospective Evaluation of a Surgical Solution for Breast Cancer-Associated Lymphedema

Biobridge
Start date: July 20, 2016
Phase: N/A
Study type: Interventional

To investigate whether addition of the Biobridge scaffold to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm.

NCT ID: NCT02724514 Completed - Breast Cancer Clinical Trials

Multi-Parametric Assessment of Breast Lymphedema

Start date: January 2015
Phase:
Study type: Observational

Breast lymphedema (swelling due to fluid) is a common complication of breast cancer therapy. Unlike lymphedema in the arm, breast lymphedema is not as well-known and has not been studied. At present, no objective and standardized tools exist to evaluate breast lymphedema. The purpose of this study is to investigate the use of ultrasound analysis and bio-impedance to determine if it is possible to measure the extent of the fluid in the breast.

NCT ID: NCT02700529 Completed - Lymphedema Clinical Trials

Ubenimex in Adult Patients With Lymphedema of The Lower Limb (ULTRA)

Start date: June 2016
Phase: Phase 2
Study type: Interventional

This proof-of-concept study is designed as a randomized, double-blind, placebo-controlled study comparing ubenimex at 150 mg, 3 times daily (total daily dose of 450 mg) with placebo for 6 months treatment period in patients with leg lymphedema.

NCT ID: NCT02676752 Completed - Lymphedema Clinical Trials

Skin/Soft Tissue Elasticity in Head and Neck Cancer Survivors With Lymphedema and Fibrosis

Start date: September 2016
Phase:
Study type: Observational

This research trial studies skin/soft tissue elasticity in head and neck cancer survivors with lymphedema and fibrosis. Lymphedema and fibrosis is a common effect of head and neck cancer which may lead to skin tightness, pain, and body image issues. Early detection of lymphedema and fibrosis may help reduce serious functional loss of the neck. Shear wave elastography is a technique that provides a quantitative measure of stiffness using a push pulse to generate shear waves within the tissues. Conventional imaging techniques are then used to monitor the shear waves generated through the tissue to calculate the shear wave speed. Shear wave elastography may help obtain an early and accurate measurement of tissue elasticity in head and neck cancer survivors.

NCT ID: NCT02650297 Completed - Lymphedema Clinical Trials

The Effect of Combined Decongestive Therapy and Pneumatic Compression Pump on Body Image in Patients With Lymphedema

Start date: October 2009
Phase: Phase 1/Phase 2
Study type: Interventional

Patients with lymphedema may experience pain and body image issues. This study investigates the effect of Combined Decongestive Therapy and pneumatic compression pump on body image in patients with lymphedema secondary to breast cancer treatment.42 women with breast cancer related lymphedema participated. All patients completed the body image and relationships scale. Researchers divided the participants randomly into an intervention (n=21) or control group (n=21). In the first phase, CDT was accompanied by use of a compression pump for four weeks, three days per week. In the second phase, Combined DecongestiveTherapy was performed daily without compression pump for four weeks by patients at home. At the end of each phase, both groups completed the questionaire. Researchers analyzed the data with SPSS v.17.