Regular exercise to help women with early-stage breast cancer on hormone therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolled 150 women with stage I–III breast cancer who have completed primary treatment and begun adjuvant hormone therapy. Participants will take part in a 16-week supervised exercise program, with one gym session and one pool session per week, tailored to individual fitness levels. The study also aims to explore how exercise affects nutritional status, immune function, and gut microbiota, and will evaluate a digital health platform to support personalized care. Researchers will collect data on general health status, physical condition, body composition, and biological markers to understand exercise-related benefits and mechanisms.

Why it matters

Who can join: the full rules

Inclusion Criteria

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.

Exclusion Criteria

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.

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.

Where it's running

• Infanta Sofía University Hospital
  San Sebastián de los Reyes, Madrid, Spain Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.