Exercise program for breast cancer patients undergoing chemotherapy
Randomized Controlled Trial of Simultaneous Exercise During Neo-/Adjuvant Chemotherapy in Breast Cancer Patients and Its Effects on Neurocognition
This study is testing if a high-intensity exercise program can help breast cancer patients undergoing chemotherapy improve their thinking skills and reduce cognitive decline.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Johannes Kepler University of Linz Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Linz, Upper Austria) |
| Trial ID | NCT04789187 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with histologically confirmed breast cancer who are scheduled for neo- and adjuvant chemotherapy.
Not a fit: Patients with significant comorbid conditions, prior cognitive impairments, or those unable to participate in physical activity will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve cognitive function and quality of life for breast cancer patients undergoing chemotherapy.
How similar studies have performed: While evidence for the positive effects of exercise on CRCI is still lacking, recent studies suggest a growing interest in this area, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Linz, Upper Austria
- Kepler University Hospital — Linz, Upper Austria, Austria (Recruiting)
Study contacts
- Study coordinator: Milan R Vosko, MD, PhD
- Email: milan.vosko@kepleruniklinikum.at
- Phone: +435768083
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.