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

NCT07539038 | Recruiting

• 1 other identifier: CRO-2022-061
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change from Baseline in Pain Intensity (Brief Pain Inventory - Short Form)

  Up to 6 months after the end of the physical activity program

• Change from Baseline in Physical Activity Levels

  Up to 6 months after the end of the physical activity program

• Change from Baseline in Dietary Habits and Nutritional Intake

  Up to 6 months after the end of the physical activity program

• Change from Baseline in Blood Test Results

  Up to 6 months after the end of the physical activity program

• incidence of Hormonal Therapy-Related Toxicities

  Through the end of the program and follow-up (up to 6 months).

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro di Riferimento Oncologico - Aviano: lead

Study Sites (1)

Centro di Riferimento Oncologico di Aviano

Aviano, Pordenone, 33081, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Mattia Garutti

CONTACT

0434659092; mattia.garutti@cro.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: April 3, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

IT (1)