Hospital Regional Universitario de Málaga
Málaga, 29009, Spain
NCT Number: NCT04974268
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.
Looking for future studies?
Notify Me18 year–80 year
Female
Interventional
Not applicable
Málaga, 29009, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline, 3rd and 6th month visits
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.
Time frame: Baseline, 3rd and 6th month visits
Measured by body composition analysis
Time frame: Baseline, 3rd and 6th month visits
Weight in kg
Time frame: Baseline, 3rd and 6th month visits
Fat free body mass in kg assessed by bioelectrical impedance analysis
Time frame: Baseline, 3rd and 6th month visits
Total fat mass in kg
Time frame: Baseline, 3rd and 6th month visits
Water in ml
Time frame: Baseline, 3rd and 6th month visits
Water in ml
Time frame: Baseline, 3rd and 6th month visits
Measured by hand and quadriceps dynamometry. Assess if strength improves after training.
Time frame: Baseline, 3rd and 6th month visits
Assess whether the level of physical activity improves after training and motivation sessions.
Time frame: Baseline, 3rd and 6th month visits
Assess if it improves after training and at 6 months of follow-up.
Time frame: Baseline, 3rd and 6th month visits
Serum albumin in g/dl
Time frame: Baseline, 3rd and 6th month visits
Serum prealbumin in mg/dl
Time frame: Baseline, 3rd and 6th month visits
Serum cholesterol in mg/dl
Time frame: Baseline, 3rd and 6th month visits
Serum LDL in mg/dl
Time frame: Baseline, 3rd and 6th month visits
Serum TG in mg/dl
Time frame: Baseline, 3rd and 6th month visits
Plasma levels of high sensitivity C reactive protein (hs-CRP) in mg/dl
Time frame: Baseline, 3rd and 6th month visits
Measured as HbA1c (glycated hemoglobin)
Time frame: Baseline, 3rd and 6th month visits
Measured aas HOMA-IR (homeostatic model assessment of insulin resistance)
Time frame: Baseline, 3rd and 6th month visits
Serum vitamin D in ng/ml
Time frame: Baseline, 3rd and 6th month visits
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
Other
Reduction of Lymphedema Secondary to Breast Cancer Through a Structured Exercise and Weight Loss Program. Randomized Controlled Trial
Acronym: EJERDIETLIF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06905639
Behavior, Breast Diseases
Ponferrada, León, Spain
View Trial DetailsNCT02506530
Breast Diseases, Breast Neoplasms
Toulouse, Midi Pyrenees, France
View Trial DetailsNCT00376597
Breast Diseases, Breast Neoplasms
Castro Valley, California, United States
View Trial DetailsNCT06808178
Breast Cancer Stage II, Breast Diseases
Cairo, Cairo Governorate, Egypt
View Trial Details