Breast Cancer Females
Conditions
Keywords
Breast Cancer Survivor, Probiotic, Immune System, Physical Exercise, Quality of Life, Gut Microbiota
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.
Interventions
OTHERPhysical Exercise and probiotic group
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.
DIETARY_SUPPLEMENTProbiotic group
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.
DIETARY_SUPPLEMENTPlacebo group
Subjects will take 3 capsules/day of placebo capsules (maltodextrin) for 12 weeks
Sponsors
Universidad Europea de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The probiotic and the placebo will be encapsulated in identical capsules and in identical cans that will only be identified with the letters A and B
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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: 0-1. * 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 * Any condition that contraindicates the exercise practice in survivors cancer (fractures risk, severe leukopenia , low platelet count) * Antibiotics intake during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of life of breast cancer survivors | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Composition | Functional capacity and physical quality will be analyzed at the beginning (baseline dose) and after 12 weeks of exercise intervention | Body Mass Index |
| Change in Muscular Capacity | Muscular capacity will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention. | Pressure manual test will be determined |
| Change in Dietary habits | Lifestyle will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention | Food Frequency Questionnaire |
| Change in Physical activity level | Lifestyle will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention | Physical activity questionnaire (IPAQ) will be used |
| Change in Functional capacity | Functional capacity and physical quality will be analyzed at the beginning (baseline dose) and after 12 weeks of exercise intervention | Dynamic fitness cardiorespiratory |
| Change in Depression state | Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention | Depression inventory (IDER) |
| Change Stress state | Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention | Stress coping questionnarie for oncology patients will be used |
| Change in Gut Microbiota | Gut microbiota will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention) | Microbial diversity, bifidobacteria and lactobacillus percentage |
| Change in Immune system | Immunoglobulin A levels will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention | Fecal immunoglobulin A levels |
| Change in Anxiety state | Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention | The State-Trait Anxiety Inventory (STAI) |
Countries
Spain
Outcome results
None listed