Breast CancerNCT07539038
Effects of Physical Activity in Early Stage Hormone Receptor Positive Breast Cancer Patients
An observational study of Breast Cancer, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial summary
The advances in early detection coupled with improvements in treatments have led to an ever-increasing number of breast cancer survivors. New methods to improve outcomes, including strategies aimed at improving the quality of life and reducing the risk of other diseases, may represent valid additions to the currently… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 3 Apr 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- Adult, Older adult
Study population: Early stage hormone receptor positive breast cancer patients participating to the Medicina and Sport
Who may be able to join
- Patients with early stage (I-IIIa) hormone receptor-positive breast cancer receiving adjuvant endocrine therapy
- Female patients ≥18 years of age
- Written informed consent must be obtained before any study-related assessment is performed
- Participation to the Medicina and Sport physical activity program organized by Andos Pordenone
Who cannot join
- Patients with early hormone receptor negative breast cancer
- Patients with early hormone receptor positive breast cancer receiving chemotherapy
- Patients with advanced/metastatic breast cancer.
- Patients receiving active treatment for secondary primary tumors (excluding basal cell carcinoma or in situ neoplasias).
- Patients with history of vertebral and/or femoral fractures
- Patients with CVDs not optimally controlled by medical therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Centro di Riferimento Oncologico di Aviano
Aviano, Pordenone, 33081
Mattia Garutti, MD, 0434659092, mattia.garutti@cro.it
Mattia Garutti, MD
About this study
The advances in early detection coupled with improvements in treatments have led to an ever-increasing number of breast cancer survivors. New methods to improve outcomes, including strategies aimed at improving the quality of life and reducing the risk of other diseases, may represent valid additions to the currently available treatment options. Interventions targeting diet, weight and physical activity can reduce the risk of cancer occurrence, prevent cancer recurrence, improve survival and the quality of life.
This is an observational, prospective study aimed at evaluating the effects of physical activity on the quality of life of patients with early stage hormone receptor positive breast cancer receiving adjuvant hormonal therapy and adhering to a physical activity program lasting for a total of 12 weeks organized by ANDOS onlus (Associazione Italiana Donne Operate al Seno).
Read the detailed description
The advances in early detection coupled with improvements in treatments have led to an ever-increasing number of breast cancer survivors. New methods to improve outcomes, including strategies aimed at improving the quality of life and reducing the risk of other diseases, may represent valid additions to the currently available treatment options. Interventions targeting diet, weight and physical activity can reduce the risk of cancer occurrence, prevent cancer recurrence, improve survival and the quality of life.
This is an observational, prospective study aimed at evaluating the effects of physical activity on the quality of life of patients with early stage hormone receptor positive breast cancer receiving adjuvant hormonal therapy and adhering to a physical activity program lasting for a total of 12 weeks organized by ANDOS onlus (Associazione Italiana Donne Operate al Seno).
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life as measured by the EORTC QLQ-C30 questionnaire.
Mean differences on the questionnaire will be evaluated. The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) is a 30-item validated tool used to assess the physical, psychological, and social functions of cancer patients. Higher scores on functional scales and the global health status represent a higher/better level of functioning, while higher scores on symptom scales represent a higher level of symptomatology.
Measured: Up to 6 months after the end of the physical activity program
Secondary outcomes (8)
Change from Baseline in Pain Intensity (Brief Pain Inventory - Short Form)
Pain intensity will be assessed using the Brief Pain Inventory (BPI) Severity score, rated on an 11-point Likert scale from 0 (no pain) to 10 (pain as bad as you can imagine). A higher score indicates greater pain intensity.
Measured: Up to 6 months after the end of the physical activity program
Change from Baseline in Physical Activity Levels
Subjective physical fitness and activity will be evaluated using the IPAQ (International Physical Activity Questionnaire). This questionnaire assesses walking, moderate-intensity, and vigorous-intensity activities. Results are reported as Metabolic Equivalent of Task (MET)-minutes per week. Higher MET-minutes indicate higher physical activity levels.
Measured: Up to 6 months after the end of the physical activity program
Change from Baseline in Dietary Habits and Nutritional Intake
Evaluated through food diaries provided during nutritional visits. The diaries assess caloric intake and macronutrient distribution (carbohydrates, proteins, fats).
Measured: Up to 6 months after the end of the physical activity program
Change from Baseline in Blood Test Results
Difference in mean of laboratory parameters as collected during routine nutritional visits to assess the metabolic impact of the program.
Measured: Up to 6 months after the end of the physical activity program
incidence of Hormonal Therapy-Related Toxicities
Frequencies of side effects and toxicities related to hormonal therapy assessed via clinical examination and patient interview according to CTCAE (Common Terminology Criteria for Adverse Events) or standard clinical practice.
Measured: Through the end of the program and follow-up (up to 6 months).
Change from Baseline in BMI
Mean difference in BMI (Body Mass Index)
Measured: Up to 6 months after the end of the physical activity program
Change from Baseline in body measures
Mean difference in body measures such as circumferences and plicometry
Measured: Up to 6 months after the end of the physical activity program
Change from Baseline in BIA
Mean difference in Bioelectrical Impedance Analysis (BIA)
Measured: Up to 6 months after the end of the physical activity program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start3 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539038
- Sponsor's protocol ID
- CRO-2022-061
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Activity in Early Stage Hormone Receptor Positive Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07539038
- Acronym / sponsor ID
- CRO-2022-061
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Apr 2026 (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.
The advances in early detection coupled with improvements in treatments have led to an ever-increasing number of breast cancer survivors. New methods to improve outcomes, including strategies aimed at improving the quality of life and reducing the risk of other diseases, may represent valid additions to the currently available treatment options. Interventions targeting diet, weight and physical activity can reduce the risk of cancer occurrence, prevent cancer recurrence, improve survival and the quality of life.
This is an observational, prospective study aimed at evaluating the effects of physical activity on the quality of life of patients with early stage hormone receptor positive breast cancer receiving adjuvant hormonal therapy and adhering to a physical activity program lasting for a total of 12 weeks organized by ANDOS onlus (Associazione Italiana Donne Operate al Seno).
Detailed description
The advances in early detection coupled with improvements in treatments have led to an ever-increasing number of breast cancer survivors. New methods to improve outcomes, including strategies aimed at improving the quality of life and reducing the risk of other diseases, may represent valid additions to the currently available treatment options. Interventions targeting diet, weight and physical activity can reduce the risk of cancer occurrence, prevent cancer recurrence, improve survival and the quality of life.
This is an observational, prospective study aimed at evaluating the effects of physical activity on the quality of life of patients with early stage hormone receptor positive breast cancer receiving adjuvant hormonal therapy and adhering to a physical activity program lasting for a total of 12 weeks organized by ANDOS onlus (Associazione Italiana Donne Operate al Seno).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Early stage hormone receptor positive breast cancer patients participating to the Medicina and Sport
Key inclusion criteria (4 listed)
- Patients with early stage (I-IIIa) hormone receptor-positive breast cancer receiving adjuvant endocrine therapy
- Female patients ≥18 years of age
- Written informed consent must be obtained before any study-related assessment is performed
- Participation to the Medicina and Sport physical activity program organized by Andos Pordenone
Key exclusion criteria (6 listed)
- Patients with early hormone receptor negative breast cancer
- Patients with early hormone receptor positive breast cancer receiving chemotherapy
- Patients with advanced/metastatic breast cancer.
- Patients receiving active treatment for secondary primary tumors (excluding basal cell carcinoma or in situ neoplasias).
- Patients with history of vertebral and/or femoral fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Quality of Life as measured by the EORTC QLQ-C30 questionnaire.
Time frame: Up to 6 months after the end of the physical activity program
Mean differences on the questionnaire will be evaluated. The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) is a 30-item validated tool used to assess the physical, psychological, and social functions of cancer patients. Higher scores on functional scales and the global health status represent a higher/better level of functioning, while higher scores on symptom scales represent a higher level of symptomatology.
8 secondary outcomes
Change from Baseline in Pain Intensity (Brief Pain Inventory - Short Form)
Time frame: Up to 6 months after the end of the physical activity program
Change from Baseline in Physical Activity Levels
Time frame: Up to 6 months after the end of the physical activity program
Change from Baseline in Dietary Habits and Nutritional Intake
Time frame: Up to 6 months after the end of the physical activity program
Change from Baseline in Blood Test Results
Time frame: Up to 6 months after the end of the physical activity program
incidence of Hormonal Therapy-Related Toxicities
Time frame: Through the end of the program and follow-up (up to 6 months).
Change from Baseline in BMI
Time frame: Up to 6 months after the end of the physical activity program
Change from Baseline in body measures
Time frame: Up to 6 months after the end of the physical activity program
Change from Baseline in BIA
Time frame: Up to 6 months after the end of the physical activity program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. 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 Italy. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mattia Garutti (0434659092, mattia.garutti@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life as measured by the EORTC QLQ-C30 questionnaire. (time frame: Up to 6 months after the end of the physical activity program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2026.