Clinical trial · Interventional
Synergic Effects of Physical Activity and Probiotic on Gut Immune System and Quality of Life of Breast Cancer Survivors.
Physical Activity Along With a Probiotic for the Immune System and Quality of Life Improvement in Breast Cancer Survivor: A Randomised Controlled Pilot Study
NCT03760653CI-TRIAL-00058675ESICAwithdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The researcher who was able to recruit the patients abandoned the project.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Females | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physical Exercise and probiotic group | Other | — | UNRESOLVED |
| Placebo group | Dietary Supplement | — | UNRESOLVED |
| Probiotic group | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Physical Exercise and probiotic 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.
- interventionNames
- Other: Physical Exercise and probiotic group
- type
- EXPERIMENTAL
- label
- Probiotic 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
- interventionNames
- Dietary Supplement: Probiotic group
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (29)
- BACKGROUNDAaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. PMID 8433390
- BACKGROUNDBattaglini CL, Mills RC, Phillips BL, Lee JT, Story CE, Nascimento MG, Hackney AC. Twenty-five years of research on the effects of exercise training in breast cancer survivors: A systematic review of the literature. World J Clin Oncol. 2014 May 10;5(2):177-90. doi: 10.5306/wjco.v5.i2.177. PMID 24829866
- BACKGROUNDBenton MJ, Schlairet MC, Gibson DR. Change in quality of life among breast cancer survivors after resistance training: is there an effect of age? J Aging Phys Act. 2014 Apr;22(2):178-85. doi: 10.1123/japa.2012-0227. Epub 2013 Apr 9. PMID 23579251
- BACKGROUNDBressa C, Bailen-Andrino M, Perez-Santiago J, Gonzalez-Soltero R, Perez M, Montalvo-Lominchar MG, Mate-Munoz JL, Dominguez R, Moreno D, Larrosa M. Differences in gut microbiota profile between women with active lifestyle and sedentary women. PLoS One. 2017 Feb 10;12(2):e0171352. doi: 10.1371/journal.pone.0171352. eCollection 2017. PMID 28187199
- BACKGROUNDCampbell KL, Pusic AL, Zucker DS, McNeely ML, Binkley JM, Cheville AL, Harwood KJ. A prospective model of care for breast cancer rehabilitation: function. Cancer. 2012 Apr 15;118(8 Suppl):2300-11. doi: 10.1002/cncr.27464. PMID 22488704
- BACKGROUNDCerda B, Perez M, Perez-Santiago JD, Tornero-Aguilera JF, Gonzalez-Soltero R, Larrosa M. Gut Microbiota Modification: Another Piece in the Puzzle of the Benefits of Physical Exercise in Health? Front Physiol. 2016 Feb 18;7:51. doi: 10.3389/fphys.2016.00051. eCollection 2016. PMID 26924990