Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT04974268
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT04974268
Study Brief:
Protocol Section:
NCT04974268