An interventional study of Exercise intervention - High intensity interval training on a cycle-ergometer in Breast Cancer and Triple Negative Breast Cancer, sponsored by University Hospital of Cologne. Not yet recruiting at 1 site in Germany. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-07-11.
Sponsored by University Hospital of Cologne · Not applicable, Interventional, and Treatment
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.
Recent clinical trials showed promising results in patients with triple negative breast cancer (TNBC) who received four cycles of pembrolizumab (at a dose of 200 mg) every three weeks + standard chemotherapy, compared to patients who received placebo + chemotherapy alone. Importantly, the overall risk of disease progression that precluded surgery, local or distant recurrence, occurrence of a second primary cancer, or death from any cause was 37% lower with pembrolizumab chemotherapy compared to placebo chemotherapy. Exercise training is a supportive multi-effect strategy with the ability to influence multiple organ systems. There is growing epidemiologic evidence that a physically active lifestyle is associated with a lower risk of developing cancer, particularly colon and breast cancer. Recent preclinical studies suggest that exercise can control and attenuate the growth of tumor cells. Therefore, exercise could be a potential means to increase the rate of pCR in cancer patients in general. High-intensity interval training resulted in higher cardiorespiratory fitness levels, particularly in breast cancer and lung patients who exercised for at least 8 weeks, with a significant improvement (from 2.40 to 4.19 mL-min-1-kg-1) observed compared to control groups. The aim of this study is to investigate the effects of HIIT training on immune system response and pCR rates (most commonly defined as complete eradication of the tumor as a surrogate parameter for good prognosis) during neoadjuvant immunochemotherapy in women with TNBC. The working hypothesis is that HIIT training would activate the immune system and enhance the combination of neoadjuvant treatment, leading to higher rates of pCR in the aerobic group compared to the usual treatment group. Thus, this exercise model may also promote microvascular perfusion, improve tumor perfusion, and potentially lead to more favorable outcomes in neoadjuvant therapy, increasing the efficacy of systemic treatments and allowing for better therapeutic outcomes. The researchers support the idea that high-intensity aerobic exercise may at least partially challenge the large heterogeneity in response to medical treatment in women with a first diagnosis of TNBC and lead to higher response rates in the experimental group.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 60 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
Any diseases that do not allow sports activity, such as:
All women in the experimental group receive standardized high-intensity interval training over a period of 6 months in combination with neoadjuvant therapy (immunochemotherapy). The individual training sessions are guided and monitored by qualified exercise therapists, taking into account the side effects of ongoing treatment. Each training session will last about one hour, with the effective training time being 30 minutes. Bike training begins 1 hour before neoadjuvant therapy and then at the same time of day between therapies. The TNBC patients start with 5 minutes of cycling followed by 3 × 3 - minute HIIT training sequences, constantly alternating: i) 30 s at 90% of maximal PO (70 rpm for 30 s) and ii) 30 s of light pedaling at 20% of PO). The training session will be concluded with a 5-min cool-down cycling (easy pedaling) and stretching. This protocol will be performed twice a week throughout the study.
Other: Exercise intervention - High intensity interval training on a cycle-ergometer
The control group will receive the standard care during their neoadjuvant therapy (immunochemotherapy) over a 6-month period.
The experimental group starts with 5 minutes of unloaded cycling, followed by 3 × 3-minute HIIT training sequences alternating between: i) 30 seconds at 90% of maximal PO (70 rpm for 30 seconds) and ii) 30 seconds of light pedaling at 20% of PO). Recent work suggests that this high-intensity approach to aerobic exercise is feasible and safe, even during acute oncology treatment. The HIIT sequences are interspersed with two 3-minute cycling sessions at moderate intensity. The training session will be concluded with a 5-minute cool-down by cycling (light pedaling) and stretching. This protocol will be performed twice a week throughout the study, and all patients who reach an 80% adherence threshold for the exercise intervention will be included in the final analysis.
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)
Time frame: After completion of neoadjuvant therapy and after surgery (6 months from study onset)
Mamma- Ultrasound (the overall response rate of tumor mass);
Ultrasound imaging
Time frame: 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
Time frame: Epidemiological data collected during the study and three years afterwards
Cardiorespiratory fitness
Measures of oxygen uptake via CPET
Time frame: 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
Time frame: 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+)
Time frame: 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);
Time frame: Baseline, and after the completion of neoadjuvant therapy (most likely 6 months after baseline)
Plan to share: Yes — All patient-related data is collected in pseudonymized form. The procedure for pseudonymization will be as follows: The investigator will receive a patient identification form in his study folder. All study patients must be entered there with their full name, date of birth, study initials, and patient documentation sheet number. The patient identification list will be kept separate from the documentation records at the center. This list must be kept completely confidential and must not leave the study center. The patient identification list must be archived for 10 years after the end of the study and then destroyed. Data processing and data management is carried out by the University Hospital Cologne. It stores all changes to the data in an audit trail and has a study-specific customizable user and role concept. The database is integrated into a general IT infrastructure and security concept with firewall and backup system.
Supporting information: Study protocol, Sap, Icf, Csr
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University Hospital of Cologne