Physical Activity Along With a Probiotic for the Immune System and Quality of Life Improvement in Breast Cancer Survivor: A Randomised Controlled Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer Females
- Sponsor
- Universidad Europea de Madrid
- Locations
- 1
- Primary Endpoint
- Change in Quality of life of breast cancer survivors
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Mar Larrosa
Senior Researcher
Universidad Europea de Madrid
Eligibility Criteria
Inclusion Criteria
- •Breast Cancer Survivors
- •\<18 aged.
- •No chemotherapy treatment or that at least three months have passed after the last chemotherapy treatment before the beginning of the study.
- •Breast cancer status: I-IV status.
- •ECOG scale: 0-
- •Normal weight.
Exclusion Criteria
- •Extreme Diet.
- •Exercise practice (at least at the doses recommended by WHO)
- •Presence of heart disease
- •Uncontrolled blood hypertension: (\>160/90 mmHg).
- •Uncontrolled metabolic disease
- •Infectious chronic disease
- •Uncontrolled pain
- •Pregnancy or breast feeding
- •Gastrointestinal disease
- •Alcoholism
Outcomes
Primary Outcomes
Change in Quality of life of breast cancer survivors
Time Frame: Quality of life will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
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)
Secondary Outcomes
- Change in Functional capacity(Functional capacity and physical quality will be analyzed at the beginning (baseline dose) and after 12 weeks of exercise intervention)
- Change in Body Composition(Functional capacity and physical quality will be analyzed at the beginning (baseline dose) and after 12 weeks of exercise intervention)
- Change in Muscular Capacity(Muscular capacity will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention.)
- Change in Physical activity level(Lifestyle will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention)
- Change in Dietary habits(Lifestyle will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention)
- Change in Anxiety state(Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention)
- Change in Depression state(Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention)
- Change Stress state(Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention)
- Change in Gut Microbiota(Gut microbiota will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention))
- Change in Immune system(Immunoglobulin A levels will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention)