Breast Cancer Clinical Trial
— ECCOOfficial title:
Randomized Controlled Trial of Simultaneous Exercise During Neo-/Adjuvant Chemotherapy in Breast Cancer Patients and Its Effects on Neurocognition
The "ECCO"-study evaluates the efficacy of simultaneous controlled exercise during neo/-adjuvant chemotherapy in breast cancer patients and its effects on neurocognition. In this study the investigators examine the benefits of the individualized high intensity training program on a cancer related cognitive impairment. Changes in patients' cognition are evaluated by neuropsychological testing. Possible structural changes are detected with MRI volumetry. Biomarkers connected to Cancer Related Cognitive Impairment (CRCI) and chemotherapy related inflammatory processes which impair cognition, respectively, will be assessed.
Status | Recruiting |
Enrollment | 126 |
Est. completion date | December 1, 2025 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Histologically confirmed breast cancer and planned neo- and adjuvant chemotherapy - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Age 18 - 70 years - Adequate hematologic functions 28d prior to randomization (Platelet count over 50 G/L, Hemoglobin over 8 g/dL) - Able to perform exercise according to protocol - Signed informed consent prior to randomization - Fluid in German Exclusion Criteria: - Significant comorbid conditions precluding participation in a physical activity program (investigators decision) - Anamnestic cognitive impairment or psychological disorders - Disabled patients unable to participate in the physical activity program or performing cognitive tests - Vigorous physical activity of >300 minutes weekly within the last year before diagnosis of breast cancer 8.3 - Patients unwilling to complete endurance exercise or complete all questionnaires related to the study - Past or current history of other malignant neoplasms other than breast cancer in the last 5 years except basal cell carcinoma of the skin and/or in situ carcinoma of the cervix - Clinically significant cardiovascular disease (including myocardial infarction < 6 month before randomization, unstable angina, symptomatic congestive heart failure NYHA II-IV, serious uncontrolled cardiac arrhythmia, preexcitation syndromes (eg Wolff-Parkinson-White-Syndrome), high grade or complete AV-Block, left bundle branch block, permanent pacemaker stimulation, uncontrolled hypertension (systolic blood pressure >160 mmHg), aortic valve stenosis, moderate to high-grade valve disease, endo-, myo-, pericarditis, acute aortic dissection, acute pulmonary embolism, acute phlebothrombosis of the lower extremity - Current pregnancy or plans to become pregnant within the next year after study entry (Pregnancy tests are included in clinical routine before every chemotherapy) - Signs of severe morphological brain damage in the baseline screening |
Country | Name | City | State |
---|---|---|---|
Austria | Kepler University Hospital | Linz | Upper Austria |
Lead Sponsor | Collaborator |
---|---|
Johannes Kepler University of Linz | Charite University, Berlin, Germany, Charles University, Czech Republic, German Sport University, Cologne, University of Graz |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognition | The primary endpoint is measured by the changes in the total score of the California Verbal Learning Test (CVLT), measured 12 months after baseline assessment. Total points of the score are 176 pts., with less points indicating a worse outcome/ cognitive impairment and more points a better outcome/ cognitive function. | 12 month | |
Secondary | Hippocampal Volume | Devation of hippocampal volume measured 12 months after baseline assessment. | 12 month |
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