Exercise, Cancer and Cognition: The ECCO-Study

NCT04789187 | Unknown DMC

• 1 other identifier: 1191/2018
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Breast Cancer

Keywords

Breast; Cancer; CRCI; Chemobrain; Cognition; Exercise; High-Intensity-Interval-Training

Outcome Measures

Primary Outcomes (1)

• Cognition

  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.

  12 month

Secondary Outcomes (1)

• Hippocampal Volume

  12 month

Study Arms (2)

Arm A: Exercise intervention arm

ACTIVE COMPARATOR

Procedure: High-Intensity-Interval-Training

Arm B: Control arm

PLACEBO COMPARATOR

Procedure: General Physical Activity Recommendations

Interventions

High-Intensity-Interval-Training PROCEDURE

Defined exercise program up to four times per week including high-intensity-interval-training for one year of active study intervention.

Arm A: Exercise intervention arm

General Physical Activity Recommendations PROCEDURE

Patients will be given general physical activity recommendations during chemotherapy.

Arm B: Control arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Kepler University of Linz: lead
• German Sport University, Cologne: collaborator
• University of Graz: collaborator
• Charite University, Berlin, Germany: collaborator
• Charles University, Czech Republic: collaborator

Study Sites (1)

Kepler University Hospital

Linz, Upper Austria, 4020, Austria

RECRUITING

Related Publications (1)

• 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.

  PMID: 35401389 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms; Chemotherapy-Related Cognitive Impairment; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Milan R Vosko, MD, PhD

  Johannes Kepler University of Linz

  STUDY CHAIR

Central Study Contacts

Milan R Vosko, MD, PhD

CONTACT

+435768083; milan.vosko@kepleruniklinikum.at

David Kiesl, MD

CONTACT

+43768083; david.kiesl@kepleruniklinikum.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Pseudonymization
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 9, 2021
• Study Start: December 1, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)