Exercise program for breast cancer patients undergoing chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The ECCO-Study evaluates the effectiveness of a high-intensity exercise program during neo/adjuvant chemotherapy in breast cancer patients, focusing on its impact on cognitive function. This randomized controlled trial will assess cognitive performance through neuropsychological tests and MRI volumetry, while also measuring inflammatory biomarkers associated with cancer-related cognitive impairment (CRCI). The study aims to provide evidence on whether exercise can mitigate cognitive decline during chemotherapy, which affects a significant number of breast cancer patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Kepler University Hospital
  Linz, Upper Austria, Austria Recruiting

Study contacts

• Study coordinator: Milan R Vosko, MD, PhD
• Email: milan.vosko@kepleruniklinikum.at
• Phone: +435768083

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.