Clinical Research Directory

Comparison of IPC Therapy as an Alternative or an Adjunct to MLD Within CDT for BCRL

Breast cancer is the most common cancer among women worldwide and lymphedema is one of its most significant complications. Breast cancer-related lymphedema (BCRL) may develop shortly after treatment or even years later, causing physical and psychological burden, functional impairment, and reduced quality of life. Complete decongestive therapy (CDT), which includes manual lymph drainage (MLD), compression, skin care, and exercise, is the standard approach. Intermittent pneumatic compression (IPC) has been proposed as an additional option, and current consensus reports emphasize the need for studies evaluating IPC in combination with MLD. Previous studies comparing IPC and MLD, either alone or in combination, have shown inconsistent results. Some reported no significant difference between treatment groups, while others suggested additional benefits of IPC, particularly in reducing limb heaviness and tension. However, there is still insufficient evidence to clarify the exact role of IPC within CDT. The aim of this study is to investigate the acute effects of using IPC instead of MLD, or in combination with MLD, on arm circumference, arm volume, shoulder range of motion, and quality of life in patients with BCRL.

Pedicled Lateral Chest Wall Lymph-Adipofascial Flap to Prevent Arm Lymphedema After Breast Cancer Surgery

Breast cancer surgery that includes removal of lymph nodes from the armpit (axillary lymph node dissection) can disrupt normal lymphatic drainage and may lead to arm swelling, known as lymphedema. This condition can cause discomfort, limit arm function, and reduce quality of life. Patients with a higher body mass index and those who receive regional lymph node radiation are at particularly high risk. This study aims to evaluate whether a preventive surgical technique, called axillary reconstruction using a pedicled lateral chest wall lymph-adipofascial flap, can reduce the risk of developing arm lymphedema after breast cancer surgery. During standard breast cancer surgery with axillary lymph node dissection, a small flap of tissue containing fat, fascia, and lymphatic tissue from the lateral chest wall is rotated into the axillary area to fill the surgical space and support lymphatic drainage. This is a prospective, single-arm Phase II clinical study. Participants will be followed for up to 24 months after surgery to assess the occurrence of arm lymphedema, changes in arm volume and bioimpedance measurements, quality of life, and surgery-related complications. The results of this study may help determine whether this simple and widely applicable technique can safely reduce the risk of lymphedema in high-risk breast cancer patients.

Combined Exercise Effects in Breast Cancer-related Lymphedema

Breast cancer-related lymphedema (BCRL) is a common and debilitating condition that affects quality of life, mobility, and well-being. While exercise was once thought to worsen symptoms, current evidence suggests it may improve lymphatic function and symptom management. The LymFit project will test a 12-week combined exercise program (aerobic + resistance) in breast cancer survivors with BCRL compared to usual care. This investigation aims to unravel the effects of a combined exercise program on BCRL management. A 12-week randomized controlled trial will be conducted with two arms: a combined exercise intervention (strength + aerobic training) and a control group. The LymFit project primarily aims to assess the effects of 12 weeks of combined exercise on L-Dex in BCRL patients. Secondary objectives include evaluating exercise's effects on i) ECW:ICW ratio (dilution techniques); ii) Body composition (dual-energy X-ray absorptiometry), handgrip strength (dynamometry), cardiorespiratory fitness, quality of life, arm disability, anxiety, depression (questionnaires), and inflammatory profile (blood analysis). The project also examines acute exercise (pre- to post-session) responses on iii) Lymphedema (L-Dex) and iv) Fluid shifts (ultrasound muscle thickness + PV measurement). By integrating clinical outcomes with mechanistic evaluations, this randomized controlled trial seeks to generate evidence-based recommendations for exercise in BCRL management and improve understanding of lymphatic fluid dynamics in this population.

Reliability of Myoton in Evaluating Skin Biomechanics in Breast Cancer-Related Lymphedema

This study aims to evaluate the intra- and inter-rater reliability of the MyotonPRO, a handheld device that measures the viscoelastic properties of the skin, in patients with breast cancer-related lymphedema. Twenty women with unilateral upper extremity lymphedema will be included. Each participant will undergo repeated skin assessments using the MyotonPRO by two independent raters. Additionally, ultrasonographic tissue characteristics and limb volume measurements will be performed. The findings are expected to contribute to the validation of the MyotonPRO for use in clinical lymphedema evaluation.

Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema

Breast cancer-related lymphedema (BCRL) is one of the most common chronic complications following breast cancer treatment. This study enrolls breast cancer patients who are required to undergo axillary lymph node dissection and postoperative adjuvant radiotherapy. Based on patients' preferences, they will be assigned to receive either immediate distal lymphaticovenous anastomosis (ID-LVA) following axillary lymph node dissection (experimental group) or not (control group). The study aims to evaluate the safety and efficacy of ID-LVA in preventing breast cancer-related upper limb lymphedema.