Physical exercise along with gut microbiota improvement -because of probiotic intake- can improve the quality of life and immune system in breast cancer survivors. This is achieved because exercise improves the muscle mass in cancer patients (often reduced by treatment and/or inactivity), together with the gut microbiota improvement, this stimulates the inmune system function, improving the quality of life of these patients.
The aim of this study is to determine the effects of physical exercise together with the supplementation of a probiotic on gut microbiota balance, the gut immune system and quality of life (intended as functional and muscular capacity, physical qualities and emotional state) in breast cancer survivors . A randomized controlled pilot study has been designed in three parallel groups. Breast cancer survivors will be randomly assigned to each of the 3 groups: a) probiotic supplementation + supervised combined physical exercise (PEF), b) probiotic supplementation and habitual sedentary lifestyle (P), and c) control group will follow their usual lifestyle and will receive a placebo (C). The exercise intervention will last 12 weeks. It will include three weekly sessions of programmed physical exercise of \~ 60 min duration (combined training). The exercise program will be individualized and will follow the rules of the world reference institutions for aerobic training. Each session will be held in a qualified fitness center and it will be supervised and individualized for each subject by professional experts .The two supplemented groups will take 3 capsules (Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus acidophilus, Bifidobacterium bifidum) a day (at night before bedtime) for 12 weeks. The variables gut microbiota, fecal levels of immunoglobulin A, cardiorespiratory capacity, anthropometry variables, lifestyle, muscular capacity, quality of life, anxiety, depression and stress levels will be analized at the beginning (baseline dose) and after 12 weeks of intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
The exercise intervention will last 12 weeks. It will include three weekly sessions of programmed physical exercise of \~ 60 min duration (aerobic and strength combined training). The exercise sessions will be individualized and will follow the rules of the world reference institutions for aerobic training. Each session will be held in a authorized fitness center and it will be supervised and individualized for each subject by expert professionals.The probiotic will be taken (3 capsules/day) for 12 weeks. Each probiotic capsule contains Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus acidophilus, Bifidobacterium bifidum.
Probiotic supplementation (3 capsules/day) will be taken before bedtime for 12 weeks.Each probiotic capsule contains Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus acidophilus, Bifidobacterium bifidum.
Mar Larrosa
Villaviciosa de Odón, Madrid, Spain
Change in Quality of life of breast cancer survivors
Breast cancer survivors quality of life will be analyzed with the quality of life questionnaire from The European Organization for Research and Treatment of Cancer EORTC QLQ BR-23 test (a specific module for breast cancer survivors)
Time frame: Quality of life will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Change in Functional capacity
Dynamic fitness cardiorespiratory
Time frame: Functional capacity and physical quality will be analyzed at the beginning (baseline dose) and after 12 weeks of exercise intervention
Change in Body Composition
Body Mass Index
Time frame: Functional capacity and physical quality will be analyzed at the beginning (baseline dose) and after 12 weeks of exercise intervention
Change in Muscular Capacity
Pressure manual test will be determined
Time frame: Muscular capacity will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention.
Change in Dietary habits
Food Frequency Questionnaire
Time frame: Lifestyle will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Change in Physical activity level
Physical activity questionnaire (IPAQ) will be used
Time frame: Lifestyle will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Change in Anxiety state
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Subjects will take 3 capsules/day of placebo capsules (maltodextrin) for 12 weeks
The State-Trait Anxiety Inventory (STAI)
Time frame: Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Change in Depression state
Depression inventory (IDER)
Time frame: Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Change Stress state
Stress coping questionnarie for oncology patients will be used
Time frame: Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Change in Gut Microbiota
Microbial diversity, bifidobacteria and lactobacillus percentage
Time frame: Gut microbiota will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention)
Change in Immune system
Fecal immunoglobulin A levels
Time frame: Immunoglobulin A levels will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention