Breast Cancer FemalesESICANCT03760653
Synergic Effects of Physical Activity and Probiotic on Gut Immune System and Quality of Life of Breast Cancer Survivors.
A study testing Physical Exercise and probiotic group and Probiotic group in people with Breast Cancer Females, run by Universidad Europea de Madrid at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer Females
- What is being tested?
- Physical Exercise and probiotic group and Probiotic group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer Females
- Being tested
- Physical Exercise and probiotic group, Probiotic group, Placebo group
- Keywords
- Breast Cancer Survivor, Probiotic, Immune System, Physical Exercise, Quality of Life, Gut Microbiota
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Exercise and probiotic groupOther
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.
Probiotic groupDietary 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.
Placebo groupDietary supplement
Subjects will take 3 capsules/day of placebo capsules (maltodextrin) for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Dietary Supplement: Probiotic group |
| Placebo group | Placebo comparator | They will follow their sedentary lifestyle. Placebo probiotic will consist of a maltodextrin capsule. Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Quality of life will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Secondary outcomes (10)
Change in Functional capacity
Dynamic fitness cardiorespiratory
Measured: Functional capacity and physical quality will be analyzed at the beginning (baseline dose) and after 12 weeks of exercise intervention
Change in Body Composition
Body Mass Index
Measured: Functional capacity and physical quality will be analyzed at the beginning (baseline dose) and after 12 weeks of exercise intervention
Change in Muscular Capacity
Pressure manual test will be determined
Measured: Muscular capacity will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention.
Change in Dietary habits
Food Frequency Questionnaire
Measured: Lifestyle will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Change in Physical activity level
Physical activity questionnaire (IPAQ) will be used
Measured: Lifestyle will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Change in Anxiety state
The State-Trait Anxiety Inventory (STAI)
Measured: Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Change in Depression state
Depression inventory (IDER)
Measured: Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Change Stress state
Stress coping questionnarie for oncology patients will be used
Measured: Emotional state will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Change in Gut Microbiota
Microbial diversity, bifidobacteria and lactobacillus percentage
Measured: Gut microbiota will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention)
Change in Immune system
Fecal immunoglobulin A levels
Measured: Immunoglobulin A levels will be analyzed at the beginning (baseline dose) and after 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start1 Oct 2018
- Primary completion1 Feb 2019
- Study completion31 Dec 2019
Why it stopped: The researcher who was able to recruit the patients abandoned the project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemalesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mar Larrosa, Universidad Europea de Madrid
- Investigators
- Fernando Herrero, PhD, Study director, Centro medicina deportiva Miranda Ebro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760653
- Sponsor's protocol ID
- UEM0002
- Acronym
- ESICA
- Status last verified
- May 2022
- First submitted
- 7 Nov 2018
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aaronson 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.
PubMed 8433390Battaglini 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.
PubMed 24829866Benton 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.
PubMed 23579251Bressa 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.
PubMed 28187199Campbell 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.
PubMed 22488704Cerda 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.
PubMed 26924990Cramp F, Byron-Daniel J. Exercise for the management of cancer-related fatigue in adults. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD006145. doi: 10.1002/14651858.CD006145.pub3.
PubMed 23152233Dulko D, Pace CM, Dittus KL, Sprague BL, Pollack LA, Hawkins NA, Geller BM. Barriers and facilitators to implementing cancer survivorship care plans. Oncol Nurs Forum. 2013 Nov;40(6):575-80. doi: 10.1188/13.ONF.575-580.
PubMed 24161636Erdman SE, Poutahidis T. Gut bacteria and cancer. Biochim Biophys Acta. 2015 Aug;1856(1):86-90. doi: 10.1016/j.bbcan.2015.05.007. Epub 2015 Jun 4.
PubMed 26050963Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
PubMed 25220842Fong DY, Ho JW, Hui BP, Lee AM, Macfarlane DJ, Leung SS, Cerin E, Chan WY, Leung IP, Lam SH, Taylor AJ, Cheng KK. Physical activity for cancer survivors: meta-analysis of randomised controlled trials. BMJ. 2012 Jan 30;344:e70. doi: 10.1136/bmj.e70.
PubMed 22294757Forsythe LP, Alfano CM, George SM, McTiernan A, Baumgartner KB, Bernstein L, Ballard-Barbash R. Pain in long-term breast cancer survivors: the role of body mass index, physical activity, and sedentary behavior. Breast Cancer Res Treat. 2013 Jan;137(2):617-30. doi: 10.1007/s10549-012-2335-7. Epub 2012 Dec 15.
PubMed 23242613Gnagnarella P, Draga D, Baggi F, Simoncini MC, Sabbatini A, Mazzocco K, Bassi FD, Pravettoni G, Maisonneuve P. Promoting weight loss through diet and exercise in overweight or obese breast cancer survivors (InForma): study protocol for a randomized controlled trial. Trials. 2016 Jul 28;17:363. doi: 10.1186/s13063-016-1487-x.
PubMed 27464488Hallal PC, Victora CG. Reliability and validity of the International Physical Activity Questionnaire (IPAQ). Med Sci Sports Exerc. 2004 Mar;36(3):556. doi: 10.1249/01.mss.0000117161.66394.07. No abstract available.
PubMed 15076800Goedert JJ, Jones G, Hua X, Xu X, Yu G, Flores R, Falk RT, Gail MH, Shi J, Ravel J, Feigelson HS. Investigation of the association between the fecal microbiota and breast cancer in postmenopausal women: a population-based case-control pilot study. J Natl Cancer Inst. 2015 Jun 1;107(8):djv147. doi: 10.1093/jnci/djv147. Print 2015 Aug.
PubMed 26032724
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03760653
- Acronym / sponsor ID
- ESICA / UEM0002
- Conditions
- Breast Cancer Females
- Keywords
- Breast Cancer Survivor, Probiotic, Immune System, Physical Exercise, Quality of Life, Gut Microbiota
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The researcher who was able to recruit the patients abandoned the project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical Exercise and probiotic group | Experimental | Other: Physical Exercise and probiotic groupThe 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. |
| Probiotic group | Experimental | Dietary Supplement: Probiotic groupParticipants 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 |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupThey will follow their sedentary lifestyle. Placebo probiotic will consist of a maltodextrin capsule. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Exercise and probiotic groupThe 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. | Other | Physical Exercise and probiotic group |
| Probiotic groupProbiotic supplementation (3 capsules/day) will be taken before bedtime for 12 weeks.Each probiotic capsule contains Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus acidophilus, Bifidobacterium bifidum. | Dietary supplement | Probiotic group |
| Placebo groupSubjects will take 3 capsules/day of placebo capsules (maltodextrin) for 12 weeks | Dietary supplement | Placebo group |
Primary outcome
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)
10 secondary outcomes
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
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
Change in Muscular Capacity
Time frame: 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
Change in Physical activity level
Time frame: 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
Change in Depression state
Time frame: 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
Change in Gut Microbiota
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Background: PubMed 8433390Aaronson 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.
- Background: PubMed 24829866Battaglini 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.
- Background: PubMed 23579251Benton 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.
- Background: PubMed 28187199Bressa 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.
- Background: PubMed 22488704Campbell 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.
- Background: PubMed 26924990Cerda 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.
- Background: PubMed 23152233Cramp F, Byron-Daniel J. Exercise for the management of cancer-related fatigue in adults. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD006145. doi: 10.1002/14651858.CD006145.pub3.
- Background: PubMed 24161636Dulko D, Pace CM, Dittus KL, Sprague BL, Pollack LA, Hawkins NA, Geller BM. Barriers and facilitators to implementing cancer survivorship care plans. Oncol Nurs Forum. 2013 Nov;40(6):575-80. doi: 10.1188/13.ONF.575-580.
- Background: PubMed 26050963Erdman SE, Poutahidis T. Gut bacteria and cancer. Biochim Biophys Acta. 2015 Aug;1856(1):86-90. doi: 10.1016/j.bbcan.2015.05.007. Epub 2015 Jun 4.
- Background: PubMed 25220842Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
- Background: PubMed 22294757Fong DY, Ho JW, Hui BP, Lee AM, Macfarlane DJ, Leung SS, Cerin E, Chan WY, Leung IP, Lam SH, Taylor AJ, Cheng KK. Physical activity for cancer survivors: meta-analysis of randomised controlled trials. BMJ. 2012 Jan 30;344:e70. doi: 10.1136/bmj.e70.
- Background: PubMed 23242613Forsythe LP, Alfano CM, George SM, McTiernan A, Baumgartner KB, Bernstein L, Ballard-Barbash R. Pain in long-term breast cancer survivors: the role of body mass index, physical activity, and sedentary behavior. Breast Cancer Res Treat. 2013 Jan;137(2):617-30. doi: 10.1007/s10549-012-2335-7. Epub 2012 Dec 15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Herrero, PhD study director
Centro medicina deportiva Miranda Ebro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Exercise and probiotic group and Probiotic group in people with Breast Cancer Females, run by Universidad Europea de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03760653, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.