Synergic Effects of Physical Activity and Probiotic on Gut Immune System and Quality of Life of Breast Cancer Survivors.

Not Applicable

Withdrawn

• Conditions: Breast Cancer Females

• Registration Number: NCT03760653
• Lead Sponsor: Universidad Europea de Madrid

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.

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-11-07
• Study First Submitted QC: 2018-11-29
• Study First Posted: 2018-11-30
• Primary Completion: 2019-02-01
• Study Completion: 2019-12-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 Anxiety state	Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention	The State-Trait Anxiety Inventory (STAI)
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

Trial Locations

Locations (1)

Mar Larrosa; 🇪🇸 Villaviciosa de Odón, Madrid, Spain