Clinical trial · Interventional
Physical Activity and Healthy Aging: Promoting Cardio-metabolic Capacity to Fight Chronic Inflammation and Improve Outcomes in Breast Cancer Patients (PhActHealth Study)
PhActHealth - Physical Activity and Healthy Aging: Fighting Low Grade Chronic Inflammation to Put Out the Cardio-oncologic Risk
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pre-habilitation exercise program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Personalized pre-habilitation exercise training program and lifestyle counseling
- description
- 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.
- interventionNames
- Behavioral: Pre-habilitation exercise program
- type
- NO_INTERVENTION
- label
- Lifestyle counseling
- description
- 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.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 \[IPAQ\]).
References
Publications (0)
Data not yet available