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NCT04241341
The researchers are doing this study to see if having immediate lymphatic reconstruction after axillary lymph node dissection (ALND) can decrease the development of lymphedema, a side effect of ALND. Other purposes of the study include: Comparing the approach of immediate lymphatic reconstruction after ALND with the approach of ALND alone Looking at whether having immediate lymphatic reconstruction after ALND improves a person's quality of life Seeing if adding standard of care radiation therapy to either study approach (immediate lymphatic reconstruction after ALND or ALND alone) has an effect on development of lymphedema
NCT06569719
Breast cancer is the most common type of cancer in women worldwide. Advances in treatment have increased survival rates, so patients must live with the complications resulting from the cancer and its treatment. One of the most common side effects is lymphedema, which can occur as a secondary effect of surgical or radiotherapy treatment. Lymphatic edema is a condition characterized by an excess of lymphatic fluid, rich in proteins, in the subcutaneous tissue, causing pain, a feeling of heaviness in the affected limb, restricted range of motion, and, in some cases, progressing to the formation of ulcers and recurrent infections; inevitably affecting the quality of life of the women who suffer from it. There are various therapeutic strategies to reduce the risk of developing lymphedema or to treat it. Among the management options is complex decongestive therapy (CDT), which is a conservative treatment that includes manual lymphatic drainage (MLD), compression therapy, skin care, and lymph-reducing exercises (LRE). Surgical options include lymph node transfer and lymphovenous anastomosis; redirecting lymphatic circulation and reducing edema in the affected limb. This is why the current research is undertaken, aiming to evaluate the effectiveness of combining these two treatment approaches in terms of reducing lymphedema, the presence of cellulitis, and changes in patients' quality of life
NCT05303675
In order to prevent lymphedema after breast surgery, patients are advised to know the risk factors for lymphedema and to avoid situations that may cause lymphedema, to perform active and passive arm exercises, to evaluate the affected area for lymphedema, to perform self-care and this should be under the self-management of the patients. Investigators think that this study will have a positive effect on the literature since there are no studies on risk scoring, the combined use of training and exercises to strengthen self-care skills in preventing the development of breast cancer-associated lymphedema. From this point of view, the study was planned as a randomized controlled experiment to examine the effects of preoperative lymphedema scoring and postoperative progressive upper extremity exercises on upper extremity function and self-care in women with breast cancer.
NCT05725265
This study is conducted to compare between efficacy of large and small area of low-level laser therapy (LLLT) in treatment of post mastectomy lymphedema. The change of severity of BCRL will be measured by the difference of circumference and skin thickness, detected by ultrasound. The influence on clinical symptoms, such as pain, shoulder mobility and hand function, are also investigated in the study.
NCT05246592
The purpose of this study is to compare the difference in the incidence of upper limb edema and dysfunction between the Preponderant lymphatic reflux group (high ratio of axillary lymphatic reflux to axillary vein reflux) and the Preponderant venous reflux group (low ratio of axillary lymphatic reflux to axillary vein reflux).
NCT04098783
Aim: The study was performed to examine effects of Health Belief Model based nursing interventions given at home visits on prevention of lymphedema in women having breast surgery. Methods: The study had an experimental design. 72 women receiving radiotherapy after breast surgery, of whom 37 formed the intervention group and 35 formed the control group. The study had an experimental design. Data were collected with a personal information questionnaire, Quick-Disabilities of the Arm, Shoulder and Hand Score (Q-DASH), European Organization for Research and Treatment of Cancer Quality of Life for Breast Cancer 23 (EORTC QLQ-BR23), Strategies Used by Patients to Promote Health (SUPPH), Arm Circumference Form at three home visits at three-month intervals. Hypotheses of the study 1. Extremity function restrictions will be lower in the intervention group than in the control group. 2. Self-efficacy levels will be higher in the intervention group than in the control group. 3. Functions improving the quality of life will be higher in the intervention group than in the control group. 4. There will be fewer symptoms reducing the quality of life in the intervention group than in the control group. 5. The incidence of lymphedema will be lower in the intervention group than in the control group. 6. The mean cost of the intervention group at home visits, will be lower than in the control group. What does this paper contribute? * Nurses can play an effective role in enabling women undergoing breast surgery to acquire behavior of lymphedema prevention. This may reduce treatment costs. * Future research should evaluate collaborative models of care in general practice aimed at improving lymphedema prevention for women undergoing breast surgery. * Policymakers should consider introducing funding measures for breast cancer survivors by nurses.
NCT04272372
Patients with breast cancer related lymphedema (clinical stage 0-2) will include in this study. Patients will take their demographic and clinical history and will evaluate with measurements of extremity volumes, body mass index, quality of life status and image studies (lymphoscintigraphy, Ultrasonography (USG), Indocyanine Green (ICG) Lymphograph or magnetic resonance imaging (MRI)) before and after the complete decongestive therapy. Outcome measurements such as limb volume, quality of life questionnaire and USG will repeat every 6,12,18, 24 months.
NCT04432727
The objective of this study is to demonstrate the feasibility of using the Flexitouch Plus with Cellular Connectivity (FT-CC) to monitor device use data to determine if reminders to patients impact compliance, and to identify the impact device compliance has on arm girth, quality of life (QOL), and symptom assessment.
NCT05595330
According to the inclusion and exclusion criteria, a total of 108 patients were enrolled and randomly divided into control group (n = 56) and intervention group (n = 52). The control group received routine nursing, while the intervention group received upper limb lymphedema prevention program for breast cancer patients after surgery. Before surgery, at the third chemotherapy (about 2.1 months after surgery) and the sixth chemotherapy (about 4.2 months after surgery), the self-designed general information questionnaire was used to investigate the patient's basic situation, and the corresponding tools were used to measure the volume of the patient's upper arm, the grip strength of the affected arm, and the range of motion of the affected shoulder joint.
NCT04245657
Breast cancer is the most frequent cancer type in women globally. In conjunction with the new developments, breast cancer survival has increased therefore the management of long-term complications has gained importance. Breast cancer survivors can face the loss of muscle strength, increased fatigue and diminished physical function associated with treatment-related long term effects and psychological affection and thereby reduced quality of life. Upper extremity lymphedema or breast cancer-related lymphedema (BCRL) is one of the most prominent long term complications which affects breast cancer survivors in many ways after breast cancer surgery. It has been reported that breast cancer survivors with BCRL have the lower muscle strength and more activity limitations when compared to the ones free of BCRL. In BCRL, affected extremity has been found to 36% more weaker when compared to the unaffected side. Fatigue is one of the most prominent symptoms when considering cancer-related symptoms in cancer survivors. It has been stated that increased fatigue is correlated with increased activity limitation and deterioration in physical function. The hand-grip test which is frequently used in the assessment of decreased muscle function has been stated as a reliable and repeatable test in breast cancer survivors. In addition, this test is frequently applicable to assess mortality, physical and functional capacity, symptoms after surgery and to designate an exercise program. There are studies that investigate upper extremity function associated with hang-grip strength in breast cancer survivors. Yet, there is a lack of the objective result or conclusion of the BCRL effect on upper extremity function which is assessed with hang-grip strength when compared without BCRL. Therefore, this study is planned to investigate of cumulative effects of factors such as lymphedema severity, age, fatigue, body mass index, muscle strength, physical activity level, pain level, exercise benefits/barriers scale score on hand-grip strength related upper extremity functionality in breast cancer survivors.
NCT03765996
One of the most common conservative treatments of lymphoedema is Complex Decongestive Physiotherapy (CDP). The bandage is one of the most important components of the treatment process. The multilayer short-stretch bandage is used to maintain volume reduction and prevent lymph backflow caused by compression. However, some patients refuse or postpone treatment or show a lower compliance with compression bandaging.Kinesio® Tex tape (KT) is a new technique for managing lymphoedema in the field of physical and alternative therapy, and it may affect decongestion of lymphatic fluid accumulated under the skin. Some studies which showed that KT was an effective for patients with BCRL, it was applied on both the affected arm and anastomosis. One of these studies also reported that a significant reduction in limb volume in patients who were applied of the tape only to the affected arm. This significant effect could also be seen by applying KT only to the anastomosis. In literature, however, there is no evidence to support this theory. So the aim of this study is to determine the effectiveness of KT which was applied to anastomotic regions along with CDP in the management of BCRL.
NCT04166279
This study emphasizes the importance of rehabilitation in breast cancer survivors after mastectomy, even during the course of radiotherapy and chemotherapy, both for good efficacy in reducing pain and for functional recovery of the upper limb. Authors designed a randomized-controlled trial to compare two different rehabilitation protocols: the single rehabilitative treatment (ST) and the group treatment (GT). The study is the first attempt to measure the reaching movement after BC surgery with an optoelectronic evaluation system previously standardized in the neurological field during rehabilitation treatment.
NCT04158193
The purpose of this study is to evaluate the clinical efficacy of acupuncture on chronic upper limb lymphedema in patients with breast cancer surgery
NCT04125953
The aim of this research is to study the influence of stochastic modulated vibrations on the autonomic nervous system of breast cancer patients during radiation therapy
NCT03333226
Breast cancer related lymphedema (BCRL) is a debilitating and distressing condition affecting approximately one out of five breast cancer survivors. BCRL is a chronic swelling of the upper arm following axillary lymph nodes dissection, and it is associated to a significant functional, psychological and social morbidity, with an heavy impact on life quality. Several studies reported BCRL incidence between 6.7% and 62.5% for different population cohorts. Randomized clinical trials (RCTs) reported that sentinel lymph node biopsy (SLNB) when compared with axillary lymph node dissection (ALND) leads to a significant reduction in postoperative complications. However, the advent of SLNB does not solve the problem of BCRL with a concrete chance to develop a lymphedema after single SLNB around 7%. Health care cost of BCRL rehabilitative treatment is not available in literature yet. Few studies considered incidence, risk factors and treatment costs of BCRL among working-age women after breast cancer treatment, reporting that BCRL population had significantly higher rehabilitative medical costs ($14,877 to $23,167) with twice as much risk to develop BCRL complications, such as lymphangitis or cellulitis when compared to "BCRL free" population (OR = 2.02, P = .009). Axillary reverse mapping (ARM) procedure claims to map and preserve arm lymphatic drainage during ALND and/or during SLNB, reducing BCRL development. ARM is developed as result of assumption that arm's lymphatic pathway is not involved by metastatic tumor cells of the primary breast cancer. However, when the arm lymph node correspond to the SLN it should be removed for correct tumor staging, thus a lymphatic drainage disruption onset will be expected with BCRL risk increase. During the ARM procedure, a fluorescence imaging technique (photodynamic procedure) is useful for detecting lymphatic drainage of the upper limb and it allows in differentiating the fluorescent ARM node from the SLN identified by the radioguided technique (99mTC-Nanocoll).