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

NCT07776951 | Recruiting DMC

• 2 other identifiers: PhActHealthG53D12001480006
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 2

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

Keywords

chronic inflammation; luminal B breast cancer; Triple Negative Breast Cancer (TNBC); lifestyle intervention; exercise; METs

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

  Change in metabolic equivalents of task (METs) at peak exercise intensity, measured during a maximal exercise stress test.

  Baseline and 6 months

Secondary Outcomes (19)

• Pathologic Complete Response (pCR)

  At surgery, following completion of neoadjuvant treatment

• Residual Cancer Burden (RCB)

  At surgery, following completion of neoadjuvant treatment

• Stromal Tumor-Infiltrating Lymphocytes (sTILs)

  Baseline diagnostic biopsy and surgery

• Tumor Angiogenesis

  Baseline diagnostic biopsy and surgery

• Tumor tissue Insulin-like growth factor 1 (IGF-1) expression

  Baseline diagnostic biopsy and surgery

Other Outcomes (19)

• Gut microbiota

  At follow up (6 and 12 months)

• Body mass index (BMI)

  Baseline and 6 months

• Fat Mass (FM)

  Baseline and 6 months

Study Arms (2)

Personalized pre-habilitation exercise training program and lifestyle counseling

EXPERIMENTAL

Participants receive specific recommendations for maintaining an active lifestyle, with additional guidance on nutritional habits, stress management, substance use, alcohol consumption, smoking, and sleep. Furthermore, participants are asked to wear a wrist-worn wearable device for the entire duration of the intervention in order to monitor their adherence to the intervention program: a 16-week personalized pre-habilitation exercise training, that includes a combination of aerobic endurance exercises, aimed at enhancing exercise capacity, and muscle-strengthening exercises, aimed at increasing muscle mass and strength.

Behavioral: Pre-habilitation exercise program

Lifestyle counseling

NO INTERVENTION

Participants receive specific recommendations for maintaining an active lifestyle, with additional guidance on nutritional habits, stress management, substance use, alcohol consumption, smoking, and sleep. Furthermore, participants are asked to wear a wrist-worn wearable device for the entire duration of the intervention in order to track physical activity habits.

Interventions

Pre-habilitation exercise program BEHAVIORAL

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.

Personalized pre-habilitation exercise training program and lifestyle counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \[IPAQ\]).

Sponsors & Collaborators

• University of Milan: lead
• University of Urbino "Carlo Bo": collaborator
• Istituto Auxologico Italiano: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator

Study Sites (2)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

NOT YET RECRUITING

University of Urbino "Carlo Bo"

Urbino, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Francesca Bianchi, PhD

  University of Milan

  PRINCIPAL INVESTIGATOR

• Christine Desmedt, PhD

  Laboratory for Translational Breast Cancer Research, Ku Leuven

  PRINCIPAL INVESTIGATOR

• Valentina Bollati, PhD

  University of Milan

  PRINCIPAL INVESTIGATOR

• Elia M Biganzoli, PhD

  University of Milan

  STUDY DIRECTOR

• Elena Barbieri, PhD

  Università degli Studi di Urbino Carlo Bo'

  PRINCIPAL INVESTIGATOR

• Roberta Biciuffi, MSc

  University of Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elia M Biganzoli, Professor

CONTACT

+39 02503 19652; elia.biganzoli@unimi.it

Roberta Biciuffi, MSc

CONTACT

roberta.biciuffi@unimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Medical Statistics

Model Details: Participants are randomized into two arms: assessed before and after the intervention with personalized pre-habilitation exercise training program and lifestyle advice.

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: August 20, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: August 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)