Physical Activity and Healthy Aging: Promoting Cardio-metabolic Capacity to Fight Chronic Inflammation and Improve Outcomes in Breast Cancer Patients (PhActHealth Study)

NCT07776951 · tracked via the Priya Life Science Italy tracker

Sponsor

University of Milan

Phase

Not applicable

Started

2026-02-01

Last updated

2026-08-20

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Pre-habilitation exercise program

Pre-habilitation exercise program: Participants undertake a 16-week personalized pre-habilitation exercise training program as follows: * Aerobic training: five times per week with an initial session duration set at 45 minutes.The initial target intensity is set at 40% of the Heart Rate Reserve (HRR). Both duration and intensity are progressively increased based on individual exercise tolerance, aiming for an intensity of approximately 60% HRR and a duration of 60 minutes per session. * Resistance training: twice per week, ensuring at least 24-48 hours of recovery between sessions. Patients follow the prescribed number of sets and repetitions demonstrated in in the video tutorials provided by the study staff.

Study 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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * being a patient with first diagnosis of primary BC; * luminal BC tumor subtype B defined as positive for estrogen and/or progesterone receptor expression, HER2 negative and high Ki-67; or triple Negative BC tumor subtype defined as negative for estrogen and/or progesterone receptor expression, HER2 negative, defined by the Pathology and Medical Oncology units as defined by the ESMO Guidelines Committee (referred to the American Society of Clinical Oncology/College of American Pathologists guidelines for assessment of hormone receptor (HR) status (i.e. ER and 4 PgR)25 and HER2 status, and by the International Ki-67 in Breast Cancer Working Group for Ki-67); * candidate for chemotherapy/immunotherapy neoadjuvant treatment; * signed informed consent for study participation; * declared being not engaged in any competitive or recreational physical activity. Exclusion Criteria: * therapeutic modifications during the intervention period; * presence of chronic conditions (such as autoimmune diseases, neurodegenerative diseases, psychiatric disorders/cognitive disabilities, chronic obstructive pulmonary disease); * presence of any condition that significantly impairs the ability to perform exercise; * pregnancy/lactation/intention to initiate pregnancy; * prior chemotherapy or immunotherapy within the past three years; * high baseline physical activity level (i.e. performing exercise at a dose of 600 MET minutes a week or greater, according to the score of the International Physical Activity Questionnaire \[IPAQ\]).

Primary outcome measure(s)

Exercise capacity — Baseline and 6 months
Change in metabolic equivalents of task (METs) at peak exercise intensity, measured during a maximal exercise stress test.

Trial sites (2)

Facility	City	Region	Status
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan	Italy	Not Yet Recruiting
University of Urbino "Carlo Bo"	Urbino	Italy	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07776951 on ClinicalTrials.gov ↗ ← All trials in Italy