Clinical trial NCT03760653: Synergic Effects of Physical Activity and Probiotic on Gut Immune System and Quality of Life of Breast Cancer Survivors.
Official title: Physical Activity Along With a Probiotic for the Immune System and Quality of Life Improvement in Breast Cancer Survivor: A Randomised Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer Females
Keywords: Breast Cancer Survivor
Probiotic
Immune System
Physical Exercise
Quality of Life
Gut Microbiota
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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: 0-1.
* 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.

Primary outcomes:
measure: Change in Quality of life of breast cancer survivors
timeFrame: Quality of life will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Secondary outcomes:
measure: Change in Functional capacity
timeFrame: Functional capacity and physical quality will be analyzed at the beginning (baseline dose) and after 12 weeks of exercise intervention
measure: Change in Body Composition
timeFrame: Functional capacity and physical quality will be analyzed at the beginning (baseline dose) and after 12 weeks of exercise intervention
measure: Change in Muscular Capacity
timeFrame: Muscular capacity will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention.
measure: Change in Dietary habits
timeFrame: Lifestyle will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
measure: Change in Physical activity level
timeFrame: Lifestyle will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
measure: Change in Anxiety state
timeFrame: Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
measure: Change in Depression state
timeFrame: Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
measure: Change Stress state
timeFrame: Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
measure: Change in Gut Microbiota
timeFrame: Gut microbiota will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention)
measure: Change in Immune system
timeFrame: Immunoglobulin A levels will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Other outcomes:
Locations:
city: Villaviciosa de Odón
country: Spain
facility: Mar Larrosa
state: Madrid
Study officials:
affiliation: Centro medicina deportiva Miranda Ebro
name: Fernando Herrero, PhD
role: STUDY_DIRECTOR
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