{"type":"trials","record":{"id":487,"source_id":"clinicaltrials-gov","external_id":"NCT07776951","title":"Physical Activity and Healthy Aging: Promoting Cardio-metabolic Capacity to Fight Chronic Inflammation and Improve Outcomes in Breast Cancer Patients (PhActHealth Study)","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.","overall_status":"Recruiting","phases":[],"study_type":"INTERVENTIONAL","sponsor":"University of Milan","enrollment":126,"countries":["Italy"],"start_date":"2026-02-01","completion_date":"2029-02-28","last_update_date":"2026-08-20","source_url":"https://clinicaltrials.gov/study/NCT07776951","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-14T02:45:05.518263+00:00","last_seen_at":"2026-09-25T06:05:41.111+00:00","metadata":{"sex":"FEMALE","acronym":"PhActHealth","age_range":"18 Years","comparator":"Lifestyle counseling","organization":"University of Milan","interventions":["Pre-habilitation exercise program"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Exercise capacity — Baseline and 6 months","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","IGF-1 receptor expression (IGF-1R) — Baseline diagnostic biopsy and surgery","Ki-67 expression — Baseline diagnostic biopsy and surgery","Lipid Profile — Baseline and 6 months","Blood glucose — Baseline and 6 months","Glycated hemoglobin (HbA1c) — Baseline and 6 months","Insulin — Baseline and 6 months","Liver function markers — Baseline and 6 months","C-reactive protein (CRP) — Baseline and 6 months","High-sensitivity C-reactive protein (hs-CRP) — Baseline and 6 months","Interleukin-6 (IL-6) — Baseline and 6 months","Neutrophil-to-lymphocyte ratio (N/L) — Baseline and 6 months","Platelet-to-lymphocyte ratio (P/L) — Baseline and 6 months","Thyroid Function — Baseline and 6 months","Epigenetic markers — Baseline and post-intervention/pre-surgery"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Breast Cancer","Pre-habilitation exercise program"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Title contains controlled term: cancer.","quality_checked_at":"2026-09-25T06:05:45.671606+00:00","duplicate_cluster_key":"id:nct07776951","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-02-01 to 2029-02-28","comparator":"Lifestyle counseling","confidence":"structured-source","population":"FEMALE · 18 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:05:41.115Z","intervention":["Pre-habilitation exercise program"],"participants":126,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Exercise capacity — Baseline and 6 months","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","IGF-1 receptor expression (IGF-1R) — Baseline diagnostic biopsy and surgery","Ki-67 expression — Baseline diagnostic biopsy and surgery","Lipid Profile — Baseline and 6 months","Blood glucose — Baseline and 6 months","Glycated hemoglobin (HbA1c) — Baseline and 6 months","Insulin — Baseline and 6 months","Liver function markers — Baseline and 6 months","C-reactive protein (CRP) — Baseline and 6 months","High-sensitivity C-reactive protein (hs-CRP) — Baseline and 6 months","Interleukin-6 (IL-6) — Baseline and 6 months","Neutrophil-to-lymphocyte ratio (N/L) — Baseline and 6 months","Platelet-to-lymphocyte ratio (P/L) — Baseline and 6 months","Thyroid Function — Baseline and 6 months","Epigenetic markers — Baseline and post-intervention/pre-surgery"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"cancer-and-aging","is_published":true,"match_reasons":["Title contains controlled term: cancer.","Abstract contains controlled term: cancer, tumor.","Source terminology contains: cancer.","Title supplies longevity context: aging.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Cancer and ageing","slug":"cancer-and-aging"}},{"topic_slug":"chronic-inflammation","is_published":true,"match_reasons":["Title contains controlled term: chronic inflammation.","Title supplies longevity context: aging.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","title context","study type"],"relevance_score":80,"intelligence_topics":{"name":"Chronic inflammation","slug":"chronic-inflammation"}},{"topic_slug":"exercise","is_published":true,"match_reasons":["Title contains controlled term: physical activity.","Abstract contains controlled term: exercise.","Source terminology contains: exercise.","Title supplies longevity context: aging.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Exercise","slug":"exercise"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/487","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}