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

European University

Status: Withdrawn

Conditions: Breast Cancer Females

Treatments: Dietary Supplement: Probiotic group; Other: Physical Exercise and probiotic group; Dietary Supplement: Placebo group

Study type: Interventional

Funder types: Other

Identifiers

NCT03760653

UEM0002

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 3 patient groups, including a placebo group

Physical Exercise and probiotic group

Experimental group

Description:

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.

Treatment:

Other: Physical Exercise and probiotic group

Probiotic group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Probiotic group

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo group