💬In plain words
What the trial is, and whether it could suit you
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:
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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