Reduction of Lymphedema Secondary to Breast Cancer Through a Structured Exercise and Weight Loss Program. Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To assess the change in volume in the limb affected by lymphedema in the intervention group vs control.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years and under 80 who have lymphedema diagnosed according to the truncated cone formula (increase of > 200 ml with respect to the contralateral) and are referred to Rehabilitation for treatment.
- •Having completed the chemotherapy and radiotherapy treatment at least 6 months prior to randomization.
- •Not having received manual lymphatic drainage in the 2 months prior to the intervention.
- •BMI > 25 y < 40 kg/m
- •Signature of informed consent.
排除标准
- •Traumatological, neurological, rheumatological or cardiovascular problems that prevent patients from performing the training.
- •Phase IIIB structured lymphedema
- •Metastatic disease.
- •Illness that prevents the subject from carrying out the program.
- •Unstable heart disease
- •Ejection fraction of the left ventricle higher than
- •Voluntary or involuntary weight loss > 10% in the last 3 months.
- •Illiterate.
- •Those who do not sign the informed consent to participate in the study.
- •Abusive intake of alcohol or other dependencies that in the opinion of the investigator could interfere with the study.
结局指标
主要结局
To assess the change in volume in the limb affected by lymphedema in the intervention group vs control.
时间窗: 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.
次要结局
- Change in total fat mass(Baseline, 3rd and 6th month visits)
- BMI (body mass index) changes(Baseline, 3rd and 6th month visits)
- Change in weight(Baseline, 3rd and 6th month visits)
- Change in water on arm affected by lymphedema(Baseline, 3rd and 6th month visits)
- Level of physical activity (IPAQ questionnaire)(Baseline, 3rd and 6th month visits)
- Changes in insuline resistance(Baseline, 3rd and 6th month visits)
- Change in serum prealbumin concentration(Baseline, 3rd and 6th month visits)
- Change in TG concentration(Baseline, 3rd and 6th month visits)
- Change in fat free body mass(Baseline, 3rd and 6th month visits)
- Change in water on arm not affected by lymphedema(Baseline, 3rd and 6th month visits)
- Change in serum albumin concentration(Baseline, 3rd and 6th month visits)
- Change in cholesterol concentration(Baseline, 3rd and 6th month visits)
- Changes in metabolic control(Baseline, 3rd and 6th month visits)
- Diet composition(Baseline, 3rd and 6th month visits)
- Quality of life (through the FACB + 4 test)(Baseline, 3rd and 6th month visits)
- Changes in vitamin D(Baseline, 3rd and 6th month visits)
- Peripheral muscle strength(Baseline, 3rd and 6th month visits)
- Change in LDL concentration(Baseline, 3rd and 6th month visits)
- Changes in plasma levels of high sensitivity C reactive protein (hs-CRP)(Baseline, 3rd and 6th month visits)