Reduction of Lymphedema Secondary to Breast Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lymphedema

Intervention / Treatment
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* Other: Specific supervised exercise and weight loss program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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/m2. Signature of informed consent. Exclusion Criteria: 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 35. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized in a 1:1 ratio
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise and nutritional program<br>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. | Other: Specific supervised exercise and weight loss program<br>* 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.<br>|
| No Intervention: Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the change in volume in the limb affected by lymphedema in the intervention group vs control. | 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. | Baseline, 3rd and 6th month visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI (body mass index) changes | Measured by body composition analysis | Baseline, 3rd and 6th month visits | 
| Change in weight | Weight in kg | Baseline, 3rd and 6th month visits | 
| Change in fat free body mass | Fat free body mass in kg assessed by bioelectrical impedance analysis | Baseline, 3rd and 6th month visits | 
| Change in total fat mass | Total fat mass in kg | Baseline, 3rd and 6th month visits | 
| Change in water on arm affected by lymphedema | Water in ml | Baseline, 3rd and 6th month visits | 
| Change in water on arm not affected by lymphedema | Water in ml | Baseline, 3rd and 6th month visits | 
| Peripheral muscle strength | Measured by hand and quadriceps dynamometry. Assess if strength improves after training. | Baseline, 3rd and 6th month visits | 
| Level of physical activity (IPAQ questionnaire) | Assess whether the level of physical activity improves after training and motivation sessions. | Baseline, 3rd and 6th month visits | 
| Quality of life (through the FACB + 4 test) | Assess if it improves after training and at 6 months of follow-up. | Baseline, 3rd and 6th month visits | 
| Change in serum albumin concentration | Serum albumin in g/dl | Baseline, 3rd and 6th month visits | 
| Change in serum prealbumin concentration | Serum prealbumin in mg/dl | Baseline, 3rd and 6th month visits | 
| Change in cholesterol concentration | Serum cholesterol in mg/dl | Baseline, 3rd and 6th month visits | 
| Change in LDL concentration | Serum LDL in mg/dl | Baseline, 3rd and 6th month visits | 
| Change in TG concentration | Serum TG in mg/dl | Baseline, 3rd and 6th month visits | 
| Changes in plasma levels of high sensitivity C reactive protein (hs-CRP) | Plasma levels of high sensitivity C reactive protein (hs-CRP) in mg/dl | Baseline, 3rd and 6th month visits | 
| Changes in metabolic control | Measured as HbA1c (glycated hemoglobin) | Baseline, 3rd and 6th month visits | 
| Changes in insuline resistance | Measured aas HOMA-IR (homeostatic model assessment of insulin resistance) | Baseline, 3rd and 6th month visits | 
| Changes in vitamin D | Serum vitamin D in ng/ml | Baseline, 3rd and 6th month visits | 
| Diet composition | Adherence to the Predimed Plus diet pattern 17 (0 - minimum adherence, 17 - maximum adherence) | Baseline, 3rd and 6th month visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphedema, breast cancer, strength training, body composition, body mass index, exercise capacity, health-related quality of life, memory, hypocaloric diet, Mediterranean diet