Interventional Recruiting
NCT07776951 on ClinicalTrials.gov
Physical Activity and Healthy Aging: Promoting Cardio-metabolic Capacity to Fight Chronic Inflammation and Improve Outcomes in Breast Cancer Patients (PhActHealth Study)
Official title: PhActHealth - Physical Activity and Healthy Aging: Fighting Low Grade Chronic Inflammation to Put Out the Cardio-oncologic Risk
- Sponsor: University of Milan
- Collaborators: University of Urbino "Carlo Bo", Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Istituto Auxologico Italiano
- Enrollment: 126 (Estimated)
- Study start: 2026-02-01 (Actual)
- Primary completion: 2028-02-28 (Estimated)
- Study completion: 2029-02-28 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- InterventionModelDescription: Participants are randomized into two arms: assessed before and after the intervention with personalized pre-habilitation exercise training program and lifestyle advice.
- Masking: None
- PrimaryPurpose: Treatment
Brief Summary
PhActHealth is a multicenter randomized controlled trial enrolling women with newly diagnosed luminal B or triple-negative breast cancer (BC) who are candidates for neoadjuvant therapy. The study aims to investigate the effects of a preoperative, unsupervised exercise training program on exercise capacity, as well as on immune response, autonomic nervous system (ANS) regulation, cardiovascular health, and tumor aggressiveness prior to surgical removal.
Participants are randomly assigned to either an intervention group or a control group. All patients receive lifestyle counseling, while those in the intervention group additionally follow a personalized aerobic and resistance exercise program throughout the neoadjuvant treatment period before surgery.
The primary outcome is the improvement in exercise capacity. The secondary outcomes are tumor-specific and systemic responses to the intervention, evaluated by analyzing molecular, metabolic, and inflammatory markers, as well as clinical and functional parameters.
Conditions
- Breast Cancer
Intervention / Treatment
- Behavioral: Pre-habilitation exercise program
Primary Outcome Measures
-
Exercise capacity
(Baseline and 6 months)
Change in metabolic equivalents of task (METs) at peak exercise intensity, measured during a maximal exercise stress test.
Countries
Italy
Locations and Investigators
-
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy (Not yet recruiting)
- Ornella Garrone
-
University of Urbino "Carlo Bo", Urbino, Italy (Recruiting)
- Elena Barbieri
Study Officials
- Francesca Bianchi, PhD (Principal Investigator) — University of Milan
- Christine Desmedt, PhD (Principal Investigator) — Laboratory for Translational Breast Cancer Research, Ku Leuven
- Valentina Bollati, PhD (Principal Investigator) — University of Milan
- Elia M Biganzoli, PhD (Study Director) — University of Milan
- Elena Barbieri, PhD (Principal Investigator) — Università degli Studi di Urbino Carlo Bo'
- Roberta Biciuffi, MSc (Principal Investigator) — University of Milan