Effects of Physical Activity in Early Stage Hormone Receptor Positive Breast Cancer Patients

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 Overview

• Status: Recruiting
• Conditions: Breast Cancer

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 Type: Observational
• Enrollment (Estimated): 44

Contacts and Locations

• Study Contact: Name: Mattia Garutti; Phone Number: 0434659092; Email: mattia.garutti@cro.it

Study Locations

• Italy
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Recruiting
      • Centro di Riferimento Oncologico di Aviano
      • Contact: Mattia Garutti, MD; Phone Number: 0434659092; Email: mattia.garutti@cro.it
      • Principal Investigator: Mattia Garutti, MD
      • Sub-Investigator: Linda Cucciniello, MD
      • Sub-Investigator: Fabio Puglisi, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Early stage hormone receptor positive breast cancer patients participating to the Medicina and Sport

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 6 months after the end of the physical activity program

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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.	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.	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)	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	Up to 6 months after the end of the physical activity program
Change from Baseline in BIA	Mean difference in Bioelectrical Impedance Analysis (BIA)	Up to 6 months after the end of the physical activity program

Collaborators and Investigators

• Sponsor: Centro di Riferimento Oncologico - Aviano

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: CRO-2022-061