Exercise may ease side effects of breast cancer treatment
NCT ID NCT07215364
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times
Summary
This Spanish trial tests whether a 6-month exercise program (combining resistance and aerobic training) can improve quality of life in 74 early breast cancer patients taking hormone therapy. Half the participants will do the exercise program three times a week, while the other half receive standard care. The study measures changes in symptoms and overall well-being over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- exercise program (combined resistance and aerobic training)
- What this could lead to
- If it works, this could show that a structured exercise program helps breast cancer patients feel better during hormone therapy.
- What could go wrong
- This is a small pilot study with only 74 patients, so results may not apply to everyone. The exercise program requires commitment, and some patients may not complete it.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 74 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Written informed consent document (ICD) prior to any specific study procedures, showing patience, willingness and ability to comply with the physical activity program in the experimental group, and scheduled visits and study procedures in both groups. 2. Patients ≥18 years of age at signing of ICD. 3. Documented histologically confirmed HR+/HER2- invasive EBC, adequately treated according to standard clinical practice and with absence of any evidence of disease (loco-regional or metastatic at distance). HR and HER2 assessments are performed under institutional guidelines. * HR testing should utilize an assay consistent with the most recent American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) Guidelines. * HER2 negativity is determined as immunohistochemistry (IHC) score 0/1+ or negative by in situ hybridization (ISH) according to the recommendations of the most recent ASCO/CAP Guidelines. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. 5. Pre-, peri-, and post-menopausal women (as determined by the investigator and according to the institutional guidelines) that have already received between 10 and 18 weeks of an AI (with or without a LHRHa) before the randomization in the study and administered according to local guidelines. Note: Patients that are candidate to receive an adjuvant CDK4/6i will only be eligible if the CDK4/6i was initiated at least 6 weeks before the randomization in the study and administered according to local guidelines. 6. Patients must have undergone adequate (definitive) loco-regional therapy (surgery with or without radiation therapy), with or without neo-/adjuvant systemic CT. 7. Patients must have an adequate organ and bone marrow function according to the standard clinical practice and institutional guidelines. 8. Patients must be able and willing to fill out repeated questionnaires on QoL, pain and fatigue, as well as to adhere to the physical activity program. 9. Fluent Spanish language skills for the complete comprehension of the questionnaires. 10. With the consent of the investigator for participation in physical training and considering the medical history of the patient. Exclusion Criteria: 1. Patients have received less than 10 weeks or more than 18 weeks of an AI (with or without a LHRHa) before the randomization in the study. 2. Patients that are candidate to receive an adjuvant CDK4/6i initiated the treatment less than 6 weeks before the randomization in the study. 3. Patients have musculoskeletal injuries. 4. Patients have known significant heart disease (myocardial infarction, unstable angina, congestive heart failure, cardiomyopathy, etc.). 5. Patients with weight over 150kg. 6. Patients have any type of illness or mental condition that prevents or compromises the well-being of the patient or compliance with the procedures. 7. Patients have any cardiovascular contraindication to physical training by the investigator. 8. Patients have been performing supervised training, either aerobic and/or resistance training (at a gym \[group or individual classes\] or in a specific sport), at least 2 days per week in the past 6 months. 9. No access and/or unable to manage the website and other digital tools (i.e. applications) for training sessions.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hopsital Clínico San Carlos
NOT_YET_RECRUITINGMadrid, 28040, Spain
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Hospital Quirón Sagrado Corazón de Sevilla
RECRUITINGSeville, 41013, Spain
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Hospital Universitario Clínico San Cecilio
RECRUITINGGranada, 18016, Spain
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Hospital Universitario de Navarra
RECRUITINGPamplona, Navarre, 31008, Spain
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Institut Català d'Oncología (ICO) L'Hospitalet
NOT_YET_RECRUITINGL'Hospitalet de Llobregat, Barcelona, 08908, Spain
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