Status:
UNKNOWN
Exercise, Cancer and Cognition: The ECCO-Study
Lead Sponsor:
Johannes Kepler University of Linz
Collaborating Sponsors:
German Sport University, Cologne
University of Graz
Conditions:
Breast Cancer
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 investigat...
Detailed Description
Background: Epidemiological research indicates that increased levels of physical activity are associated with decreased breast cancer risk and mortality. Thereby, exercise programs can substantially i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT04789187
Start Date
December 1 2019
End Date
December 1 2025
Last Update
March 12 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kepler University Hospital
Linz, Upper Austria, Austria, 4020