Breast Cancer Early Stage Breast Cancer (Stage 1-3)NCT07893327
Evaluation of the Effect of Regular Physical Exercise in Breast Cancer.
A study testing Supervised exercise program in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares at 1 site in Spain.
Trial summary
This study, titled "Evaluation of the effect of regular physical exercise in women with breast cancer on adjuvant hormone therapy," is a research project designed to see how guided exercise can help women recovering from breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- Supervised exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 17 Jan 2026to Dec 2028
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To participate in the study, subjects must meet all of the following requirements:
- Age and Diagnosis: Women over 18 years old diagnosed with Stage I, II, or III invasive breast carcinoma.
- Treatment Status: Must have completed primary oncological treatment (surgery, chemotherapy, and/or radiotherapy) and be within the first three months of starting adjuvant hormone therapy (tamoxifen or aromatase inhibitors).
- Physical Condition: A good general health status, defined as an ECOG performance status of 0-2, and the functional ability to perform supervised moderate physical exercise.
- Technical Requirements: Access to the internet and the ability to use the mobile application required for study evaluations.
- Consent: Voluntary agreement to participate, confirmed by a signed written informed consent form.
Who cannot join
- Patients will be excluded from the study if they meet any of the following conditions:
- Prior Exercise Habits: Having performed regular physical exercise (one hour or more per week) during the last six months.
- Limiting Symptoms: Presence of symptoms such as fever, chest pain, dizziness, blurred vision, or vomiting that would limit exercise.
- Clinical Parameters: Analytical lab results showing hemoglobin below 10 g/dL or a platelet count below 50,000.
- Medical Pathologies: Uncontrolled arrhythmias, heart failure, recent head trauma (within the last month), untreated osteoporosis, COPD, or cognitive impairment, among other contraindicating conditions.
- Oncological Status: Distant metastases or an active oncological disease other than breast cancer.
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- Medications and Supplements: Currently taking or having taken antibiotics or probiotic supplements within the last 1.5 months.
- Other Factors: Pregnancy, breastfeeding, travel difficulties, or any inability to comply with the required technological follow-up.
- The selection process is prospective, aiming to recruit a total of 150 patients over three phases (50 patients per year). Participants who meet all criteria but do not wish to follow the exercise program may be assigned to the control group.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Infanta Sofía University Hospital
San Sebastián de los Reyes, Madrid, 28702
Merino, MD PhD, +34911914171, mmerinos.hulp@salud.madrid.org
About this study
Official title: Evaluation of the Effect of Regular Physical Exercise in Women With Breast Cancer Undergoing Adjuvant Hormonal Therapy.
This study, titled "Evaluation of the effect of regular physical exercise in women with breast cancer on adjuvant hormone therapy," is a research project designed to see how guided exercise can help women recovering from breast cancer.
Here is a simple summary of the study:
Read more
Who is it for? The study includes 150 women who have finished their primary treatments (like surgery or chemotherapy) and are in the early stages of hormone therapy.
The Goal: Researchers want to understand how regular exercise improves quality of life, physical fitness, and nutrition. They are also studying how exercise affects the immune system and the gut microbiota (the healthy bacteria in your body).
The Exercise Program: Participants take part in a 16-week supervised program. It consists of two sessions per week: one in a gym and one in a swimming pool. These sessions are led by experts and are specifically adapted to each patient's physical condition and needs.
Using Technology: To help with the study, participants use a mobile app (IALIBIRD) and a wearable activity tracker (like a bracelet). These tools monitor daily steps, sleep quality, and heart rate, and allow patients to report how they feel.
Medical Check-ups: Throughout the study, patients have regular visits to the hospital for blood tests and to provide saliva and stool samples for biological analysis. They also have body scans (DXA) to measure bone health, muscle mass, and body fat.
Why is this important? While hormone therapy is a vital treatment, it can last for 5 to 10 years and cause side effects like extreme tiredness, joint pain, and anxiety. This study aims to prove that regular exercise is a safe and effective way to reduce these symptoms and help women feel better during their recovery.
Read the detailed description
- Study Overview and Justification This project is an experimental clinical study promoted by a multidisciplinary consortium including IMDEA Nutrition, Hospital Universitario Infanta Sofía (HUIS), CSIC, and the Polytechnic University of Madrid (UPM). Breast cancer is the most frequent tumor in women, and approximately 70% of cases are hormone-receptor positive, requiring adjuvant hormone therapy for 5 to 10 years. While effective, this treatment often causes side effects like fatigue (asthenia), joint pain, anxiety, and bone density loss, which significantly diminish patients' quality of life. Scientific evidence suggests that exercise can reduce cancer risk, improve survival, and mitigate these side effects by modulating molecular pathways (like IGF-1), stimulating the immune system (NK cells), and improving the gut microbiota.
- Objectives and Primary Variables The general objective is to evaluate how a regular exercise program impacts the quality of life, physical condition, body composition, nutritional status, and biological markers of these patients. Specific objectives include: Designing a digital health framework for personalized care. Identifying microbiota profiles and genetic polymorphisms (SNPs) that correlate with exercise response. Analyzing epigenetic marks (DNA methylation) and metabolomic profiles. Evaluating the usability and adherence to the IALIBIRD-CM digital platform. The primary variable is the variation in general health status and quality of life measured through validated questionnaires and biological biomarkers.
- Study Population and Selection The study will recruit 150 participants across three yearly phases (50 patients per phase). Inclusion Criteria: Women over 18 with Stage I, II, or III breast cancer; finished primary treatment (surgery, chemo, or radiotherapy); within their first 3 months of hormone therapy (Tamoxifen or Aromatase inhibitors); and an ECOG status of 0-2. Exclusion Criteria: Patients already exercising regularly (>1 hour/week in the last 6 months); presence of metastases; or current use of antibiotics/probiotics (within 1.5 months).
- The Exercise Intervention The intervention consists of a 16-week (4-month) supervised program. Participants attend two sessions per week at the Dehesa Boyal Sports Center: one in a gym/multipurpose room and one in a pool. The program is divided into four blocks: Month 1 (Adaptation): Focus on technical familiarization, mobility, and tolerance with low intensity. Month 2 (Base Construction): Increasing volume and introducing light-to-moderate loads. Month 3 (Moderate Progression): Improving functional strength and cardiorespiratory capacity. Month 4 (Consolidation): Focused on functional circuits and autonomy. Intensity is individually monitored using the Borg Scale of Perceived Exertion (targeting a score of 5-6 by Month 4) and heart rate trackers.
- Multidimensional Evaluation and Biomarkers Patients undergo five hospital visits (V0 to V4) for comprehensive monitoring: Anthropometry: Body composition is measured via DXA scans (bone density, muscle mass, and visceral fat) and bioimpedance. Omics \& Lab Tests: Blood, stool, saliva, and 24-hour urine samples are analyzed for: Gut Microbiota: 16S rRNA sequencing to study bacterial diversity. Genetics/Epigenetics: Analysis of SNPs related to metabolism and inflammation, and genome-wide DNA methylation. Immune Markers: Flow cytometry to study lymphocyte populations (NK, CD8+, etc.) and immunosenescence markers. Questionnaires: Validated tools assess quality of life (EORTC QLQ-C30/BR-23), depression (PHQ-9), anxiety (STAI), sleep (Pittsburgh), and cognitive status ("chemobrain").
- Digital Health and Artificial Intelligence A cornerstone of the study is the IALIBIRD-CM platform, which uses a mobile app and wearables. Passive Variables: Real-time data on steps, sleep efficiency, and heart rate variability. Active Variables: Ecological Momentary Assessment (EMA) allows patients to report mood, fatigue, and symptoms directly through the app. AI Integration: The study explores machine learning to identify patient profiles and predict treatment responses, eventually moving toward a federated data architecture to protect privacy in clinical settings.
- Ethics and Data Management The study adheres to the Declaration of Helsinki and strict EU/Spanish data protection regulations (RGPD). Participants provide written informed consent and may withdraw at any time. Data is handled through a pseudo-anonymized system using platforms like REDCap to ensure participant privacy and data integrity.
- Being tested
- Supervised exercise program
- Keywords
- breast cancer, physical activity
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exercise programOther
6-week supervised exercise program for women with Stage I-III breast cancer receiving hormone therapy. Participants perform two weekly sessions (one gym, one pool) at the Dehesa Boyal Sports Center, led by specialists. The intervention progresses through four monthly phases: adaptation, base building, moderate progression, and consolidation. Intensity is tailored using the Borg Scale and heart rate monitors.
A central component is the IALIBIRD-CM digital platform, where patients use an app and wearables to track activity, sleep, and symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The experimental arm consists of a 16-week supervised exercise program for women with Stage I-III breast cancer receiving hormone therapy. Participants perform two weekly sessions (one gym, one pool) at the Dehesa Boyal Sports Center, led by specialists. The intervention progresses through four monthly phases: adaptation, base building, moderate progression, and consolidation. Intensity is tailored using the Borg Scale and heart rate monitors.
A central component is the IALIBIRD-CM digital platform, where patients use an app and wearables to track activity, sleep, and symptoms. Monitoring includes DXA scans for body composition and regular collection of blood, saliva, urine and stool samples. These help researchers analyze changes in the gut microbiota, immune markers, and genetics to understand how exercise improves quality of life and mitigates treatment side effects Receives: Other: Supervised exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life
Evaluate the effect of a regular physical exercise intervention compared with standard care on health-related quality of life in patients with breast cancer using EORTC QLQ-BR42 questionnaires.
Measured: through study completion, an average of 1 year
Secondary outcomes (17)
Change in physical activity level asseseed by IPAQ.
Physical activity level will be assessed using the International Physical Activity Questionnaire (IPAQ). Higher scores indicate higher levels of physical activity.
Measured: through study completion, an average of 1 year
Bioelectrical impedance analysis (BIA).
Assess changes in nutritional status and body composition using bioelectrical impedance analysis (BIA).
Measured: through study completion, an average of 1 year
Change in Mediterranean Diet Adherence Screener (MEDAS) score
Adherence to the Mediterranean dietary pattern will be evaluated using the MEDAS questionnaire.
Measured: through study completion, an average of 1 year
Change in dietary intake
Assess dietary intake using a Food Frequency Questionnaire and a three-day dietary record.
Measured: through study completion, an average of 1 year
Change in sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI).
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index.
Measured: through study completion, an average of 1 year
Change in depressive symptoms assessed by Patient Health Questionnaire-9 (PHQ-9).
Depressive symptom severity will be measured using the Patient Health Questionnaire-9.
Measured: through study completion, an average of 1 year
Change in anxiety symptoms assessed by IPIP-ANX.
Anxiety symptoms will be assessed using the IPIP Anxiety scale.
Measured: through study completion, an average of 1 year
Change in perceived cognitive function assessed by FACT-Cog.
Cognitive function will be assessed using the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog)
Measured: through study completion, an average of 1 year
Genetic and epigenetic biomarkers measured by Illumina Infinium Methylation chips.
Genetic and epigenetic biomarkers will be assessed at baseline through analysis of selected SNPs and DNA methylation profiles using commercially available panels related to cancer progression, lifestyle factors, metabolic regulation, hematopoietic alterations, and microbiota-associated pathways.
Measured: Baseline
Longitudinal Changes in Gut Microbiota Composition and Diversity Assessed by 16S rRNA Gene Sequencing
Gut microbiota composition and microbial functional profiles will be characterized at baseline and throughout follow-up to assess changes associated with physical activity and lifestyle factors.
Measured: through study completion, an average of 1 year
Metabolomic and immunosenescence biomarker modulation
Changes in metabolomic profiles and immunosenescence-associated molecular markers will be evaluated to characterize the biological effects of the intervention
Measured: through study completion, an average of 1 year
Progression-Free Survival (PFS) and Overall Survival (OS)
PFS and OS by investigator assessment.
Measured: From date of randomization until the end of follow-up, assessed up to 52 weeks
Usability and Acceptability of the Digital Health Platform
Assess the usability, user experience, participant satisfaction, and adherence associated with the digital health platform implemented as a support tool for the study.
Measured: Through study completion, an average of 1 year
Change in patient activation assessed by PAM-13.
Knowledge, skills, and confidence for self-management will be assessed, using the 13-item Patient Activation Measure (PAM-13).
Measured: Through study completion, an average of 1 year
Longitudinal Changes in Clinical Laboratory Parameters Assessed by Routine Laboratory Tests
Assess changes over time in routine clinical laboratory parameters, including complete blood count, coagulation profile, blood biochemistry, lipid profile, and glycemic profile.
Measured: Through study completion, an average of 1 year
Nutritional Biomarkers
Assess changes in nutritional biomarkers, including vitamins (A, B1, B6, B9, B12, C, D, and E), iron, ferritin, zinc, magnesium, selenium, sodium, potassium, chloride, calcium, phosphorus, copper, albumin, and prealbumin.
Measured: Through study completion, an average of 1 year
Inflammatory Biomarkers
Assess changes in inflammatory biomarkers, including interleukin (IL)-1β, IL-6, IL-8, IL-10, tumor necrosis factor alpha (TNF-α), and C-reactive protein (CRP).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start17 Jan 2026
- Primary completionOct 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Investigación E Innovación Biomédica Hospital Universitario Infanta Sofia-Henares
- Sponsor type
- University, hospital or other
- Collaborators
- IMDEA Food, Fundación General CSIC, Universidad Politecnica de Madrid
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893327
- Sponsor's protocol ID
- IALIBIRD-CM1
- Other IDs
- TEC-2024/BIO-281
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No