Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
126 participants
INTERVENTIONAL
2019-12-01
2025-12-01
Brief Summary
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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.
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Detailed Description
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Patients and Methods: This prospective, two-arm, 1:1 randomized, controlled trial aims to investigate the influence of high-intensity training interventions accompanying neo/-adjuvant chemotherapy on CRCI in 126 patients with early breast cancer on cognitive performance measured by the California Verbal Learning Test (CVLT). Secondary endpoints include subjective markers and tests for cognitive performance and inflammatory biomarkers as TNF-α, IL-6, IL-1α, IL-1ß which are suspected to be involved in the pathogenesis of CRCI. As cognitive impairments are believed to be connected to either functional and/or morphological hippocampal damage due to chemotherapy, head MRIs and hippocampal volume measurements will be performed. In addition to a heart rate controlled home-based endurance and strength training for one year, participants in the intervention group will perform a supervised high-intensity interval training (HIIT) exercise program at least once a week. This study will help to clarify whether a long-term supervised exercise intervention program affects CRCI in breast cancer patients and help to reason underlying mechanisms and the pathogenesis of the chemobrain.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Arm A: Exercise intervention arm
High-Intensity-Interval-Training
Defined exercise program up to four times per week including high-intensity-interval-training for one year of active study intervention.
Arm B: Control arm
General Physical Activity Recommendations
Patients will be given general physical activity recommendations during chemotherapy.
Interventions
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High-Intensity-Interval-Training
Defined exercise program up to four times per week including high-intensity-interval-training for one year of active study intervention.
General Physical Activity Recommendations
Patients will be given general physical activity recommendations during chemotherapy.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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German Sport University, Cologne
OTHER
University of Graz
OTHER
Charite University, Berlin, Germany
OTHER
Charles University, Czech Republic
OTHER
Johannes Kepler University of Linz
OTHER
Responsible Party
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Milan Vosko, MD, PhD
Principal Investigator
Principal Investigators
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Milan R Vosko, MD, PhD
Role: STUDY_CHAIR
Johannes Kepler University of Linz
Locations
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Kepler University Hospital
Linz, Upper Austria, Austria
Countries
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Central Contacts
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Facility Contacts
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References
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Kiesl D, Kuzdas-Sallaberger M, Fuchs D, Brunner S, Kommenda R, Tischler C, Hornich H, Akbari K, Kellermair J, Blessberger H, Ocenasek H, Hofmann P, Zimmer P, Vosko MR. Protocol for the Exercise, Cancer and Cognition - The ECCO-Study: A Randomized Controlled Trial of Simultaneous Exercise During Neo-/Adjuvant Chemotherapy in Breast Cancer Patients and Its Effects on Neurocognition. Front Neurol. 2022 Mar 25;13:777808. doi: 10.3389/fneur.2022.777808. eCollection 2022.
Other Identifiers
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1191/2018
Identifier Type: -
Identifier Source: org_study_id
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