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

Breast Cancer Females Clinical Trial

— ESICA  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03760653
• Other study ID #: UEM0002
• Status: Withdrawn
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2022
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Females
• Breast Neoplasms

Intervention

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.

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 group
Subjects will take 3 capsules/day of placebo capsules (maltodextrin) for 12 weeks

Locations

Country	Name	City	State
Spain	Mar Larrosa	Villaviciosa de Odón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

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