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

May 17, 2022 updated by: Mar Larrosa, Universidad Europea de Madrid

Physical Activity Along With a Probiotic for the Immune System and Quality of Life Improvement in Breast Cancer Survivor: A Randomised Controlled Pilot Study

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Villaviciosa de Odón, Madrid, Spain, 28670
        • Mar Larrosa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical Exercise and probiotic group
The subjects will receive 3 weekly sessions of combined exercise supervised by professionals in a specialized gym (60 minutes each one). The exercise will consist of a combination of aerobic and strength exercises involving the main muscle groups. They will take the probiotic supplementation at the established dose, 3 capsules/day before bedtime. Each probiotic capsule contains Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus acidophilus, Bifidobacterium bifidum.
Other: Physical 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.
Experimental: Probiotic group
Participants will follow their usual sedentary lifestyle (i.e to practice less than 3 days a week of physical exercise, as is specified in the inclusion criteria). They will take the probiotic supplementation at the established dose. Each probiotic capsule contains Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus acidophilus, Bifidobacterium bifidum
Dietary supplement: Probiotic 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.
Placebo Comparator: Placebo group
They will follow their sedentary lifestyle. Placebo probiotic will consist of a maltodextrin capsule.
Dietary supplement: Placebo group
Subjects will take 3 capsules/day of placebo capsules (maltodextrin) for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Quality of life will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional capacity
Time Frame: Functional capacity and physical quality will be analyzed at the beginning (baseline dose) and after 12 weeks of exercise intervention
Dynamic fitness cardiorespiratory
Functional capacity and physical quality will be analyzed at the beginning (baseline dose) and after 12 weeks of exercise intervention
Change in Body Composition
Time Frame: Functional capacity and physical quality will be analyzed at the beginning (baseline dose) and after 12 weeks of exercise intervention
Body Mass Index
Functional capacity and physical quality will be analyzed at the beginning (baseline dose) and after 12 weeks of exercise intervention
Change in Muscular Capacity
Time Frame: Muscular capacity will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention.
Pressure manual test will be determined
Muscular capacity will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention.
Change in Dietary habits
Time Frame: Lifestyle will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Food Frequency Questionnaire
Lifestyle will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Change in Physical activity level
Time Frame: Lifestyle will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Physical activity questionnaire (IPAQ) will be used
Lifestyle will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Change in Anxiety state
Time Frame: Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
The State-Trait Anxiety Inventory (STAI)
Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Change in Depression state
Time Frame: Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Depression inventory (IDER)
Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Change Stress state
Time Frame: 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
Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Change in Gut Microbiota
Time Frame: Gut microbiota will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention)
Microbial diversity, bifidobacteria and lactobacillus percentage
Gut microbiota will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention)
Change in Immune system
Time Frame: Immunoglobulin A levels will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Fecal immunoglobulin A levels
Immunoglobulin A levels will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Europea de Madrid

Investigators

  • Study Director: Fernando Herrero, PhD, Centro medicina deportiva Miranda Ebro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

November 7, 2018

First Submitted That Met QC Criteria

November 29, 2018

First Posted (Actual)

November 30, 2018

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UEM0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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