Blood and Lymph Conditions

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Behaviors and Mental Disorders

Lymphedema

Breast Neoplasms

Neoplasm Metastasis

Weight Loss

Body Weight

Lymphatic Diseases

Quality of Life

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)

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Nutritional and Metabolic Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Obesity

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

The diet programme will be characterized by carbohydrates (60 %); proteins (20 %, half comprised of vegetable proteins); total fat (20 %; saturated fat \< 10 %). After calculating the patient's energy need, the amount of calories will be successively adjusted to create an 800 kcal deficit per day.

The diet programme will be characterized by carbohydrates (50%),total lipids (30%) and proteins (20%). After calculating the patient's energy need, the amount of calories will be successively adjusted to create an 800 kcal deficit per day.

50 pcos women will be assigned to hypocaloric mediterranean diet for 6 months

mediterranean diet, restricted calorie

50 pcos women will be assigned to standardized hypocaloric diet for 6 months

hypocaloric diet, restricted calorie

Francesco Orio, MD

Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of reproductive-aged women that manifests itself with chronic anovulation, hyperandrogenism and insulin resistance. Available guidelines recommend lifestyle intervention although they do not suggest the best dietetic regimen for the treatment of PCOS. Thus, the purpose of this study is to compare the effectiveness of two nutritional protocols, namely Mediterranean Diet and Hypocaloric Diet in PCOS women.

PCOS is the most common endocrine disorder of reproductive age women, that is often associated with chronic anovulation, hyperandrogenism and insulin resistance. The central importance of insulin resistance in the pathogenesis of the syndrome has been established by several in vivo and in vitro studies. No data are available for the best therapeutical approach for metabolic dysfunction of PCOS. The new guidelines for the management of metabolic risk in PCOS strongly recommended that overweight/obese women with PCOS should lose weight changing their lifestyle. Although calorie-restricted diets are currently recommended to reach the healthy weight, there are still unsatisfied data regarding the best dietetic regimen that should be suggested.

In this study, our purpose is to compare two nutritional protocols in order to find the best dietetic approach for improving clinical, metabolic and hormonal outcomes in pcos women.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Mediterranean Diet Versus Hypocaloric Diet in PCOS	NCT02397174	Polycystic Ovar...	mediterranean d... hypocaloric die...	18 Years - 35 Years	Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

Spots Global Cancer Trial Database for hypocaloric diet