Exercise Intervention in Women Diagnosed With Triple-negative Breast Cancer Receiving Oncologic Treatment
NCT Number: NCT06497322
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breast Cancer|Triple Negative Breast Cancer
Interventions: OTHER: Exercise intervention - High intensity interval training on a cycle-ergometer
Sponsor: University Hospital of Cologne
Collaborators: St. Elisabeth Krankenhaus Köln-Hohenlind
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-12-31
Locations: University Hospital of Cologne and St. Elizabeth Hospital, Cologne, NRW, 50937, Germany

Summary:
In this randomized, controlled, prospective, two-arm intervention study, the investigators plan to investigate the effects of high-intensity interval training in women diagnosed with triple-negative breast cancer. Breast cancer is one of the most common cancers and one of the leading causes of cancer-related deaths worldwide. Among the different subtypes, triple-negative breast cancer accounts for about 15-20% of all breast cancer cases and is characterized by a more aggressive clinical course. Recent results indicate that the percentage of patients with a pathologic complete response was 13% higher in the chemotherapy-immunotherapy group (by 64.8%) than in the placebo-chemotherapy group (51.2). High-intensity interval training has a positive effect on the immune system, suggesting that it may improve the efficacy of chemo-immunotherapy, leading to a higher rate of pathologic complete response (pCR) in patients with newly diagnosed triple-negative breast cancer. In addition to the immunomodulatory effects, this exercise model could boost microvascular perfusion, thereby improving tumor perfusion, enhancing chemo-immunotherapy and leading to better outcomes.

Primary Outcome Measures: Pathological complete remission of the tumor (pCR);, The absence of residual invasive cancer of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0/Tis ypN0 in the current AJCC staging system), After completion of neoadjuvant therapy and after surgery (6 months from study onset)
Secondary Outcome Measures: Mamma- Ultrasound (the overall response rate of tumor mass);, Ultrasound imaging, Baseline (prior to any data collection or therapy administration), and every three weeks during neoadjuvant chemotherapy|Progression free survival and Overall survival, Clinically relevant data, Epidemiological data collected during the study and three years afterwards|Cardiorespiratory fitness, Measures of oxygen uptake via CPET, At baseline (prior to any data collection or therapy administration), three months after baseline, and six months after baseline (following completion of neoadjuvant therapy)|OCTA - optical coherence tomography angiography, Measure of blood vessel compliance for the eye, At baseline (prior to any data collection or therapy administration) and after the completion of neoadjuvant therapy (most commonly 6 months)|Biomarkers of immune response, Blood sampling to measure i) Longitudinal dynamics of soluble biomarkers such as e.g. CRP (mg/dL); ii) Longitudinal dynamics of blood counts such as e.g. leukocytes (cells/uL); iii) Longitudinal dynamics of immune cell subsets measured by flow-cytometry such as e.g. activated T-cells (CD8+HLA-DR+), At baseline (prior to any data collection or therapy administration) and after the completion of neoadjuvant therapy (most commonly 6 months)|Quality of life, cancer-related fatigue, treatment tolerance and side-effects; physical activity behavior., Questionnaire items (0 - 100 scale, with 0 being lower and 100 being the higher, positive outcome);, Baseline, and after the completion of neoadjuvant therapy (most likely 6 months after baseline)