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Recruiting NCT07539038

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

— Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Primary outcome measures

  • 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]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Centro di Riferimento Oncologico di Aviano — Aviano

Identifiers

NCT: NCT07539038 · CRO-2022-061

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗