Blood and Lymph Conditions

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Neoplasms

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Symptoms and General Pathology

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Lymphedema

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Intervention group that receives supervised exercise and weight loss program based on individual and group intervention with Mediterranean diet and substitute for a daily meal (non-mandatory), manual lymphatic drainage and compression garment if there is more than 600 ml of excess volume in the limb affected.

Control group will receive recommendations for aerobic unsupervised exercise 150 min per week, standard dietary recommendations (Mediterranean diet pattern and 1800 Kcal diet), manual lymphatic drainage and compression garment if there is more than 600 ml of excess volume in the limb affected.

Intervention group that receives supervised exercise and weight loss program based on individual and group intervention with Mediterranean diet and substitute for a daily meal, manual lymphatic drainage and compression garment if there is more than 600 ml of excess volume in the limb affected.

Specific supervised exercise and weight loss program

Gabriel Olveira, MD, PhD

This study evaluates the reduction of lymphedema and its complications in obese women treated with a muscle training and weight loss program as well as the improvement body composition, muscle strength, quality of life and neurocognitive function, compared to a conventional treatment control group.

Introduction: Breast cancer is the most frequent tumour in women. Breast cancer-related lymphedema (BCRL) occurs in 10 to 36% of patients undergoing dissection and emptying of axillary nodes and between 5 and 17% undergoing sentinel node biopsy. BCRL is associated with discomfort, pain, risk of infections, disability, symptoms of depression and anxiety and worse quality of life. The prevalence of persistent lymphedema increases with the presence of obesity.

Aim: In overweight or obese women with BCRL to assess whether a muscle training and weight loss program reduces lymphedema volume and its associated complications, as well as improves body composition, muscle strength, quality of life and neurocognitive function, compared to a conventional treatment control group.

Methodology: Open prospective randomized trial of 2 parallel arms. Subjects: patients referred to the Rehabilitation Unit with lymphedema secondary to breast cancer and overweight or obesity. The control group will receive the usual treatment and general dietary recommendations and the intervention group will carry out a program of supervised exercise (strength and aerobic) and weight loss (based on the Mediterranean diet and with a meal replacement). The change in volume in the limb affected by lymphedema, segmental body composition and phase angle (impedance measurement), muscular strength (hand dynamometry), level of physical activity (IPAQ), dietary parameters, quality of life (FACB+4) will be assessed. Cognitive function (Memory FSRCT test), psychological symptoms (anxiety and depression by means of HADS) NS biochemical parameters (albumin, prealbumin, lipids, CRP, 25-OH vitamin D and insulin) will be analyzed.

Patients will be randomized in a 1:1 ratio

Reduction of Lymphedema Secondary to Breast Cancer

Reduction of Lymphedema Secondary to Breast Cancer Through a Structured Exercise and Weight Loss Program. Randomized Controlled Trial

It will be studied whether a reduction of 200 ml of the affected arm is achieved with respect to itself and / or with respect to the healthy one, after training.

Fat free body mass in kg assessed by bioelectrical impedance analysis

Measured by hand and quadriceps dynamometry. Assess if strength improves after training.

Assess whether the level of physical activity improves after training and motivation sessions.

Assess if it improves after training and at 6 months of follow-up.

Plasma levels of high sensitivity C reactive protein (hs-CRP) in mg/dl

Measured aas HOMA-IR (homeostatic model assessment of insulin resistance)

Adherence to the Predimed Plus diet pattern 17 (0 - minimum adherence, 17 - maximum adherence)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Reduction of Lymphedema Secondary to Breast Cancer	NCT04974268	Lymphedema	Specific superv...	18 Years - 80 Years	Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Reduction of Lymphedema Secondary to Breast Cancer	NCT04974268	Lymphedema	Specific superv...	18 Years - 80 Years	Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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