Exercise, Cancer and Cognition: The ECCO-Study

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04789187

Studienbeginn:
Dezember 2019

Letztes Update:
12.03.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Johannes Kepler University of Linz

Collaborator:
German Sport University, Cologne, University of Graz, Charite University, Berlin, Germany, Charles University, Czech Republic,

Studienleiter

Milan R Vosko, MD, PhD
Study Chair
Johannes Kepler University of Linz

Kontakt

Milan R Vosko, MD, PhD
Kontakt:
Phone: +435768083
Phone (ext.): 6672
E-Mail: milan.vosko@kepleruniklinikum.at» Kontaktdaten anzeigen

David Kiesl, MD
Kontakt:
Phone: +43768083
Phone (ext.): 1610
E-Mail: david.kiesl@kepleruniklinikum.at» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Kepler University Hospital
4020 Linz
AustriaRekrutierend» Google-Maps
Ansprechpartner:
David Kiesl, MD
Phone: +435768083
Phone (ext.): 1610
E-Mail: david.kiesl@kepleruniklinikum.at

Milan R Vosko, MD, PhD
Phone: +43768083
Phone (ext.): 6672
E-Mail: milan.vosko@kepleruniklinikum.at» Ansprechpartner anzeigen

Studien-Informationen

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 increase patients' quality of life during and after treatment. Up to 80% of

breast cancer patients demonstrate a decrease in their cognitive capacity, summarized as the

symptom-complex "Cancer Related Cognitive Impairment (CRCI)". Most frequently reported

impairments are mild to moderate deficits in processing speed, attention, memory and

executive functions. In about 35% of affected patients, cognitive symptoms persist for

months, or even years, after completion of medical treatment, impairing daily functioning,

limiting ability to return to work and decreasing overall quality of life. Recent studies

indicate a key role of inflammatory pathways in the CRCI genesis. Attention to physical

activity therefore as a potential supportive care option is increasing. Anyhow, evidence for

positive effects of exercise on CRCI is still lacking.

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Cognition (Time Frame - 12 month):
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.

Secondary outcome:

1. Hippocampal Volume (Time Frame - 12 month):
Devation of hippocampal volume measured 12 months after baseline assessment.

Studien-Arme

Active Comparator: Arm A: Exercise intervention arm
Placebo Comparator: Arm B: Control arm

Geprüfte Regime

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.

Quelle: ClinicalTrials.gov

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