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11,009 result(s) for "Lymphedema"
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Bioimpedance spectroscopy for breast cancer-related lymphedema assessment: clinical practice guidelines
PurposeBreast cancer-related lymphedema (BCRL) represents a significant concern for patients following breast cancer treatment, and assessment for BCRL represents a key component of survivorship efforts. Growing data has demonstrated the benefits of early detection and treatment of BCRL. Traditional diagnostic modalities are less able to detect reversible subclinical BCRL while newer techniques such as bioimpedance spectroscopy (BIS) have shown the ability to detect subclinical BCRL, allowing for early intervention and low rates of chronic BCRL with level I evidence. We present updated clinical practice guidelines for BIS utilization to assess for BCRL.Methods and ResultsReview of the literature identified a randomized controlled trial and other published data which form the basis for the recommendations made. The final results of the PREVENT trial, with 3-year follow-up, demonstrated an absolute reduction of 11.3% and relative reduction of 59% in chronic BCRL (through utilization of compression garment therapy) with BIS as compared to tape measurement. This is in keeping with real-world data demonstrating the effectiveness of BIS in a prospective surveillance model. For optimal outcomes patients should receive an initial pre-treatment measurement and subsequently be followed at a minimum quarterly for first 3 years then biannually for years 4–5, then annually as appropriate, consistent with previous guidelines; the target for intervention has been changed from a change in L-Dex of 10 to 6.5. The lack of pre-operative measure does not preclude inclusion in the prospective surveillance model of care.ConclusionThe updated clinical practice guidelines present a standardized approach for a prospective model of care using BIS for BCRL assessment and supported by evidence from a randomized controlled trial as well as real-world data.
Axillary Surgery in Breast Cancer — Primary Results of the INSEMA Trial
Whether surgical axillary staging as part of breast-conserving therapy can be omitted without compromising survival has remained unclear. In this prospective, randomized, noninferiority trial, we investigated the omission of axillary surgery as compared with sentinel-lymph-node biopsy in patients with clinically node-negative invasive breast cancer staged as T1 or T2 (tumor size, ≤5 cm) who were scheduled to undergo breast-conserving surgery. We report here the per-protocol analysis of invasive disease-free survival (the primary efficacy outcome). To show the noninferiority of the omission of axillary surgery, the 5-year invasive disease-free survival rate had to be at least 85%, and the upper limit of the confidence interval for the hazard ratio for invasive disease or death had to be below 1.271. A total of 5502 eligible patients (90% with clinical T1 cancer and 79% with pathological T1 cancer) underwent randomization in a 1:4 ratio. The per-protocol population included 4858 patients; 962 were assigned to undergo treatment without axillary surgery (the surgery-omission group), and 3896 to undergo sentinel-lymph-node biopsy (the surgery group). The median follow-up was 73.6 months. The estimated 5-year invasive disease-free survival rate was 91.9% (95% confidence interval [CI], 89.9 to 93.5) among patients in the surgery-omission group and 91.7% (95% CI, 90.8 to 92.6) among patients in the surgery group, with a hazard ratio of 0.91 (95% CI, 0.73 to 1.14), which was below the prespecified noninferiority margin. The analysis of the first primary-outcome events (occurrence or recurrence of invasive disease or death from any cause), which occurred in a total of 525 patients (10.8%), showed apparent differences between the surgery-omission group and the surgery group in the incidence of axillary recurrence (1.0% vs. 0.3%) and death (1.4% vs. 2.4%). The safety analysis indicates that patients in the surgery-omission group had a lower incidence of lymphedema, greater arm mobility, and less pain with movement of the arm or shoulder than patients who underwent sentinel-lymph-node biopsy. In this trial involving patients with clinically node-negative, T1 or T2 invasive breast cancer (90% with clinical T1 cancer and 79% with pathological T1 cancer), omission of surgical axillary staging was noninferior to sentinel-lymph-node biopsy after a median follow-up of 6 years. (Funded by the German Cancer Aid; INSEMA ClinicalTrials.gov number, NCT02466737.).
Advances in the prevention and treatment of breast cancer-related lymphedema
PurposeBreast cancer-related lymphedema (BCRL) represents a lifelong risk for breast cancer survivors and once acquired becomes a lifelong burden. This review summarizes current BCRL prevention and treatment strategies.FindingsRisk factors for BCRL have been extensively studied and their identification has affected breast cancer treatment practice, with sentinel lymph node removal now standard of care for patients with early stage breast cancer without sentinel lymph node metastases. Early surveillance and timely management aim to reduce BCRL incidence and progression, and are further facilitated by patient education, which many breast cancer survivors report not having adequately received. Surgical approaches to BCRL prevention include axillary reverse mapping, lymphatic microsurgical preventative healing (LYMPHA) and Simplified LYMPHA (SLYMPHA). Complete decongestive therapy (CDT) remains the standard of care for patients with BCRL. Among CDT components, facilitating manual lymphatic drainage (MLD) using indocyanine green fluorescence lymphography has been proposed. Intermittent pneumatic compression, nonpneumatic active compression devices, and low-level laser therapy appear promising in lymphedema management. Reconstructive microsurgical techniques such as lymphovenous anastomosis and vascular lymph node transfer are growing surgical considerations for patients as well as liposuction-based procedures for addressing fatty fibrosis formation from chronic lymphedema. Long-term self-management adherence remains problematic, and lack of diagnosis and measurement consensus precludes a comparison of outcomes. Currently, no pharmacological approaches have proven successful.ConclusionProgress in prevention and treatment of BCRL continues, requiring advances in early diagnosis, patient education, expert consensus and novel treatments designed for lymphatic rehabilitation following insults.
Effect of exercise mode on physical function and quality of life in breast cancer–related lymphedema: a randomized trial
Purpose This study aimed to compare the effects of virtual reality (VR) training and resistance exercises training on lymphedema symptom severity as well as physical functioning and QoL in women with breast cancer–related lymphedema (BCRL). Methods In a single blinded randomized trial, women diagnosed with unilateral BCRL were randomly divided into two groups: the Xbox Kinect group received VR Kinect-based games ( n  = 30) and resistance exercise group received resistance training ( n  = 30). In addition, both groups received complex decongestive physiotherapy (manual lymphatic drainage, compression bandages, skin care, and exercises). The intervention was conducted five sessions per week for 8 weeks. The outcome measures included excessive limb volume, visual analogue scale (VAS), the Disability of the Arm, Shoulder, and Hand (DASH) questionnaire, shoulder range of motion (ROM), shoulder muscles strength, hand grip strength, and Study Short-Form (SF-36). The outcomes were evaluated pre and post intervention (week 8). Results Statistical significant differences were recorded in VAS (pain intensity), DASH, shoulder ROM ( p  < 0.001), bodily pain ( p  = 0.002), general health ( p  < 0.001), and vitality ( p  = 0.006) in favor of the Xbox Kinect group. However, there were statistically significant differences in shoulder flexion strength ( p  = 0.002), external rotation strength ( p  = 0.004), and abduction strength and handgrip strength ( p  < 0.001) in favor of the resistance exercise group. Conclusions The VR training was superior to resistance exercises training in BCRL management. The empirical findings support the VR as a new effective and encouraging intervention modality which can assist in improving physical functioning and quality of life in women with BCRL. Trial registration This study is retrospectively registered at ClinicalTrials.gov (ID: NCT04724356).
The LYMPH trial: comparing microsurgical with conservative treatment for chronic breast cancer-associated lymphoedema – study protocol of a pragmatic randomised international multicentre superiority trial
IntroductionUp to one-fifth of breast cancer survivors will develop chronic breast cancer-related lymphoedema (BCRL). To date, complex physical decongestion therapy (CDT) is the gold standard of treatment. However, it is mainly symptomatic and often ineffective in preventing BCRL progression. Lymphovenous anastomosis (LVA) and vascularised lymph node transfer (VLNT) are microsurgical techniques that aim to restore lymphatic drainage. This international randomised trial aims to evaluate advantages of microsurgical interventions plus CDT versus CDT alone for BCRL treatment.Methods and analysisThe effectiveness of LVA and/or VLNT in combination with CDT, which may be combined with liposuction, versus CDT alone will be evaluated in routine practice across the globe. Patients with BCRL will be randomly allocated to either surgical or conservative therapy. The primary end point of this trial is the patient-reported quality of life (QoL) outcome ‘lymphoedema-specific QoL’, which will be assessed 15 months after randomisation. Secondary end points are further patient-reported outcomes (PROs), arm volume measurements, economic evaluations and imaging at different time points. A long-term follow-up will be conducted up to 10 years after randomisation. A total of 280 patients will be recruited in over 20 sites worldwide.Ethics and disseminationThis study will be conducted in compliance with the Declaration of Helsinki and the International Council for Harmonisation-Good Clinical Practice (ICH-GCP) E6 guideline. Ethical approval has been obtained by the lead ethics committee ‘Ethikkommission Nordwest- und Zentralschweiz’ (2023-00733, 22 May 2023). Ethical approval from local authorities will be sought for all participating sites. Regardless of outcomes, the findings will be published in a peer-reviewed medical journal. Metadata detailing the dataset’s type, size and content will be made available, along with the full study protocol and case report forms, in public repositories in compliance with the Findability, Accessibility, Interoperability and Reuse principles.Trial registration number NCT05890677.
Preventive effects of progressive resistance training of different intensities on breast cancer–related lymphedema
Purpose Explore the preventive effects of varying intensity progressive resistance exercise on breast cancer-related lymphedema. Methods A total of 114 breast cancer patients who underwent axillary lymph node dissection at Tangshan People’s Hospital from January to April 2024 were included. Participants were randomly assigned to three groups: the control group received conventional care; intervention group 1 received conventional care + low-intensity progressive resistance exercise; and intervention group 2 received routine nursing + moderate and high-intensity progressive resistance exercise. Body composition and grip strength were assessed pre-intervention, post-intervention, and at 3 and 6 months follow-up to compare differences among the groups. Results (1) Body composition: At post-intervention, 3 and 6 months follow-up, segmental water differences and extracellular water ratios, along with 1- and 5-kHz SFBIA in both intervention groups, were lower than in the control group. Intervention group 2 had a lower extracellular water ratio than group 1 at post-intervention, and at 3 months follow-up, group 2 showed lower water differences and extracellular water ratios than group 1, with slight variations at 6 months ( P  < 0.001). (2) Grip strength: At post-intervention, 3 months and 6 months follow-up, grip strength in intervention group 1 and intervention group 2 was higher than that in control group, and the difference was statistically significant ( P  < 0.001). Conclusion Resistance exercise enhances muscle strength and prevents lymphedema, with moderate-high-intensity exercise proving more effective than low intensity. Adverse events were minimal, suggesting that increasing resistance exercise intensity, while considering participants’ conditions, may yield better preventive outcomes.
A Randomized Trial Evaluating Bioimpedance Spectroscopy Versus Tape Measurement for the Prevention of Lymphedema Following Treatment for Breast Cancer: Interim Analysis
Background Breast cancer-related lymphedema (BCRL) represents a major source of morbidity among breast cancer survivors. Increasing data support early detection of subclinical BCRL followed by early intervention. A randomized controlled trial is being conducted comparing lymphedema progression rates using volume measurements calculated from the circumference using a tape measure (TM) or bioimpedance spectroscopy (BIS). Methods Patients were enrolled and randomized to either TM or BIS surveillance. Patients requiring early intervention were prescribed a compression sleeve and gauntlet for 4 weeks and then re-evaluated. The primary endpoint of the trial was the rate of progression to clinical lymphedema requiring complex decongestive physiotherapy (CDP), with progression defined as a TM volume change in the at-risk arm ≥ 10% above the presurgical baseline. This prespecified interim analysis was performed when at least 500 trial participants had ≥ 12 months of follow-up. Results A total of 508 patients were included in this analysis, with 109 (21.9%) patients triggering prethreshold interventions. Compared with TM, BIS had a lower rate of trigger (15.8% vs. 28.5%, p   <  0.001) and longer times to trigger (9.5 vs. 2.8 months, p   =  0.002). Twelve triggering patients progressed to CDP (10 in the TM group [14.7%] and 2 in the BIS group [4.9%]), representing a 67% relative reduction and a 9.8% absolute reduction ( p   =  0.130). Conclusions Interim results demonstrated that post-treatment surveillance with BIS reduced the absolute rates of progression of BCRL requiring CDP by approximately 10%, a clinically meaningful improvement. These results support the concept of post-treatment surveillance with BIS to detect subclinical BCRL and initiate early intervention.
Impact of a self management mobile application on quality of life and limb circumference in women with breast cancer related lymphedema
Breast cancer-related lymphedema (BCRL) adversely affects the daily performance and quality of life (QoL) in affected patients. This study aimed to determine the Impact of a self-management mobile application on quality of life and limb circumference in women with BCRL. This randomized clinical trial was conducted on 180 patients with BCRL in Shiraz, Iran, from May 2023 to January 2024. The participants were randomly assigned to the intervention ( n  = 90) and control ( n  = 90) groups. The control group received the normal treatments at the lymph clinic. In addition to the usual clinic treatments, the intervention group had access to a mobile application for 3 months. The primary outcomes were QoL, assessed using the Lymphedema Life Impact Scale (LLIS), and the difference in arm circumference, measured using a standard tape. After the intervention, the mean (SD) LLIS score in the intervention group was 29.1 (10.7), which was significantly lower than the control group with 39.3 (15.5). This difference was statistically significant ( p  < 0.001), indicating a substantial improvement in QoL in the intervention group compared to the control group. Additionally, the intervention group showed a lower mean (SD) arm circumference difference of 2.18 (1.4) compared to the control group with 3.78 (2.6). This result also was statistically significant ( p  < 0.001). Therefore, we recommend using the application to support self-management among women with BCRL.