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Lymphedema clinical trials

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NCT ID: NCT01385488 Completed - Lymphedema Clinical Trials

Bioelectrical Impedance for Self-monitoring of Lymphedema

Start date: May 2011
Phase: N/A
Study type: Interventional

- Breast cancer treatment-related lymphedema requires life-long self-care is required. - No objective measurement mechanism exists that can easily be used to self-monitor arm volume. - Bioelectrical impedance devices approved for lymphedema measurement may be able to be used for self-monitoring. - The investigators will conduct a two-part study to first develop an impedance driven self-measurement protocal and then test the protocol in home settings. - The investigators hypothesize in part two of the study that when compared to participants who are not self-monitoring, those who self-monitor limb volume will: 1) report more days of garment use, skin care, and simple-MLD; and, 2) have fewer, less distressful, less intense symptoms, better productivity/activity, report higher perceived self-management/self-efficacy and QOL; experience fewer missed days of work, lymphedema treatment days, arm infections, and have a smaller number of antibiotic prescriptions.

NCT ID: NCT01351376 Completed - Breast Cancer Clinical Trials

LLLT Combined With CDT in Breast Cancer-Related Lymphedema

Start date: May 2011
Phase: N/A
Study type: Interventional

This study aims to explore the effects of Low Level Laser Therapy (LLLT) on breast cancer-related lymphedema when utilized in conjunction with Complex Decongestive Therapy (CDT) when compared to CDT treatment alone. The investigators hypothesize that the addition of LLLT to CDT will result in statistically significant improvements and greater long-term benefits as measured by changes in arm volume and quality of life when compared to the benefits of CDT alone for the treatment of breast cancer-related lymphedema.

NCT ID: NCT01336790 Recruiting - Lymphedema Clinical Trials

International Lymphatic Disease and Lymphedema Registry

Start date: March 2009
Phase:
Study type: Observational

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.

NCT ID: NCT01318785 Recruiting - Lymphedema Clinical Trials

Therapeutical Assessment of Compression Armsleeves for Lymphatic Indications

BF09-PH-01
Start date: September 2011
Phase: Phase 2
Study type: Interventional

Examination of therapeutical effects of different types of armsleeves in treating lymphatic diseases after breast cancer surgery during maintenance phase 1. thesis: - all types should be equal regarding volume reduction 2. thesis: armsleeves manufactured with microfibre yarn are expected to be - better in wearing comfort and - better in handling features.

NCT ID: NCT01279018 Completed - Pain, Postoperative Clinical Trials

Persistent Pain After Breast Cancer Treatment With Docetaxel

Start date: October 2010
Phase: N/A
Study type: Observational

Breast cancer treatment is for many patients followed by sequelae, such as persistent pain, sensory disturbances, lymphedema and reduced physical function. These undesired consequences of the treatment are a major clinical problem, with persistent pain affecting 25-60%, sensory disturbances 20-80%, lymphedema 2-86% and reduced physical function 13-28% of patients. Development of persistent pain after breast cancer treatment, involves a complex pathophysiology that involves pre-, intra- and postoperative factors. Several risk factors for the development of persistent pain after breast cancer treatment have been identified; young age, psychosocial factors, surgical procedure and radiation therapy. Neurotoxicity is a well know attribute of many chemotherapeutic agents, such as taxanes. The purpose of this nationwide study is to retrospectively examine a cohort of breast cancer patients treated with docetaxel, to clarify if docetaxel may influence the prevalence and intensity of persistent pain and other sequelae.

NCT ID: NCT01276054 Terminated - Lymphedema Clinical Trials

Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients.

Start date: December 2010
Phase: Phase 2
Study type: Interventional

Lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity of arm lymphedema. This randomized phase II trial is studying how well sentinel and/or axillary lymph node biopsy with or without axillary reverse mapping works in reducing incidence and severity of lymphedema in patients with resectable stage 0-II breast cancer

NCT ID: NCT01273909 Enrolling by invitation - Breast Cancer Clinical Trials

Outcomes After Perforator Flap Reconstruction for Breast Reconstruction and/or Lymphedema Treatment

Start date: July 2010
Phase: N/A
Study type: Observational

The goal of this prospective, observational study is to investigate the clinical, psychosocial, and patient satisfaction outcomes of patients who undergo perforator flap reconstruction for breast reconstruction and/or vascularized lymph node transfer (VLNTx) for the treatment of lymphedema. The investigators hypothesize that (1) perforator flap breast reconstruction will result in excellent clinical, psychosocial, and patient satisfaction outcomes compared to non-perforator flap breast reconstruction; (2) perforator flap breast reconstruction is associated with less persistent postsurgical pain than other forms of breast reconstruction, even after controlling for major cofactors, such as the extent of auxiliary lymph node dissection and the use of radiation therapy; (3) perforator flap reconstruction for the treatment of Lymphedema (i.e., VLNTx ) will result in the reduction of symptoms and complications of lymphedema.

NCT ID: NCT01239160 Terminated - Lymphedema Clinical Trials

Two Pneumatic Compression Devices in the Treatment of Lower Extremity Lymphedema

ACE
Start date: November 2, 2010
Phase: N/A
Study type: Interventional

The treatment of lymphedema has been a major focus of attention for physicians and scientists for several decades. At this time, no successful techniques have been developed to prevent lymphedema, and therefore, a great deal of emphasis is placed on treatment modalities that can lessen the severity and impede the progression of this debilitating condition. The treatment on offer usually consists of a maintenance phase using compression garments and an intensive treatment phase, which includes the use of skin care, compression bandaging, exercise and manual lymphatic drainage (MLD). The intensive phase is usually described as complex decongestive therapy (CDT). This is time consuming and requires high resource usage. Pneumatic compression devices (PCD) offer and alternative to MLD and can be used by the patient. There are a number of devices on the market that are categorized into 1. without calibrated gradient compression 2. With calibrated gradient compression. This trial will compare two PCDs, a simple device without calibrated compression, and an advanced device with calibrated compression, in the reduction of swelling and maintenance of reduced limb volume in 262 patients with lower limb lymphoedema. The primary end point will be limb volume reduction over 12 weeks of treatment, with secondary outcome after 24 weeks.

NCT ID: NCT01187173 Completed - Depression Clinical Trials

The Fibrosis-Lymphedema Continuum in Head and Neck Cancer

Start date: July 2010
Phase: N/A
Study type: Observational

Goal: The primary goal of this study is to longitudinally investigate, in head and neck cancer (HNC) patients, the potential fibrosis-lymphedema continuum. Specifically, we will examine the development, patterns, progression, and prevalence of late-effect fibrosis and/or lymphedema, explore potential biological correlatives including pro-inflammatory cytokines and genetic polymorphisms, and evaluate the relationship among late-effect fibrosis and/or lymphedema and select psychosocial stressors that potentially interact with cytokine pathways. H: A minimum of 20 percent of HNC patients will experience late-effect fibrosis and/or lymphedema. H: We will be able to differentiate characteristics patterns of the development of late-effect fibrosis and/or lymphedema. H: We will be able to differentiate patterns of symptoms associated with late-effect fibrosis and/or lymphedema. H: We will be able to differentiate patterns of inflammatory response and the development of late-effect fibrosis and/or lymphedema. H: Select polymorphisms will increase the likelihood of development of late-effect fibrosis and/or lymphedema. H: Incidence and severity of late-effect fibrosis and/or lymphedema will correlate with total dose of radiation to involved anatomical site. H: HNC patients with fibrosis and/or lymphedema experience greater levels of depression and social withdrawal than those without these conditions.

NCT ID: NCT01152099 Completed - Lymphoedema Clinical Trials

A Clinical Trial About the Contribution of Manual Lymph Drainage in Complex Physical Therapy for Patients With Lymphoedema Secondary to Mastectomy

Start date: September 11, 2007
Phase: N/A
Study type: Interventional

Hypothesis: To know the utility of manual lymph drainage (MLD) as part of the Physical Complex Therapy has turn out relevant because of the exclusive dedication that it supposes to the therapist. To date, the evidence-base for MLD is very limited and only two studies analyze its relevance. The first study measured the effect of compression bandage with or without MLD. The group receiving compression and MLD had a significant reduction in limb volume and decreased pain, despite the fact the MLD was given only for one week (Johansson et al., 1999). A further study investigated the effect of eight sessions of MLD over two weeks in 42 women with breast cancer-related lymphoedema, and the findings suggested that MLD do not contribute significantly to oedema reduction, although the MLD course was relatively short and the study group was limited to those with mild to moderate swelling (20-30 % of difference). Information about the quality of life, using the questionnaire EORT QLQ-C30 was gathered but the results were not considered in the final assessment (Andersen and Cabbage 2000). Similar studies would provide comparative and enlightening information with regard to the previous results. The investigators could determine if the MLD, in spite of not obtaining an improvement in the volume of the lymphoedema, provides a benefit in the reduction of the symptoms related to it. The investigators hypothesized that MLD does not contribute significantly in volume limb reduction but it provides a clinical improvement regarding the quality of life according to the questionnaire EORT QLQ-C30. For the calculation of the sample size the investigators depart from the following assumptions: The effect of the standard treatment on the control group control will produce an average volume limb reduction of 5 %. The effect of the treatment in the experimental group will be an average of the 25 % (a minor difference of effects would indicate a discreet effect of the tested treatment). The investigators also assume that, the standard deviation will be similar in both groups and near to 25 %. With this information and for an alpha risk of 0.05 and a power of 0.80 the calculation of the sample size is 20 patients in every group. Considering a rate of withdrawal of 30 % in every group, the appropriate sample size is 58 patients assigned in two groups of 29 patients. Main aim: To analyze the effectiveness of Manual Lymph Drainage (MLD) in the treatment of postmastectomy lymphoedema in order to reduce the volume of lymphoedema Secondary aims: To analyze the duration of the reduction of the lymphoedema in the time. To analyze the improvement in the concomitant symptomatology of the lymphoedema using the results of two quality of life tests validated in Spanish: EORTC QLQ-C30 version 2.0, for the cancer in general and EORTC QLQ-BR23 specifically for the breast cancer. In particular, the items refering to the upper extremity (47, 48, 49) and to the corporal image (39, 40, 41, 42) and in which the higher the score the worse the result. Methodology: Researching Project with methodology of randomized, controlled clinical trial. Group A or Control: patients with standard treatment (care the skin, exercise and measures of compression -bandage for one month and later a sleeve of compression). Group B or Experimental: patients with standard treatment (care of the skin, exercise and measures of compression (bandage for one month and later a sleeve for lymphoedema) and in addition they receive Manual Lymph Drainage Main variable: Volume reduction of the affected arm after the treatment expressed in percentage. Number of patients: 58 women.