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

NCT03760653 | Withdrawn

• 1 other identifier: UEM0002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Females

Keywords

Breast Cancer Survivor; Probiotic; Immune System; Physical Exercise; Quality of Life; Gut Microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Change in Functional capacity

  Functional capacity and physical quality will be analyzed at the beginning (baseline dose) and after 12 weeks of exercise intervention

• Change in Body Composition

  Functional capacity and physical quality will be analyzed at the beginning (baseline dose) and after 12 weeks of exercise intervention

• Change in Muscular Capacity

  Muscular capacity will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention.

• Change in Dietary habits

  Lifestyle will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention

• Change in Physical activity level

  Lifestyle will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention

Study Arms (3)

Physical Exercise and probiotic group

EXPERIMENTAL

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

Probiotic group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

They will follow their sedentary lifestyle. Placebo probiotic will consist of a maltodextrin capsule.

Dietary Supplement: Placebo group

Interventions

Physical Exercise and probiotic group OTHER

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.

Physical Exercise and probiotic group

Probiotic group DIETARY_SUPPLEMENT

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.

Probiotic group

Placebo group DIETARY_SUPPLEMENT

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Female breast cancer survivors
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Mar Larrosa

Villaviciosa de Odón, Madrid, 28670, Spain

Location

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MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Fernando Herrero, PhD

  Centro medicina deportiva Miranda Ebro

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 30, 2018
• Study Start: October 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: December 31, 2019
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

ES (1)