Clinical trial · Interventional
Exercise, Cancer and Cognition: The ECCO-Study
Randomized Controlled Trial of Simultaneous Exercise During Neo-/Adjuvant Chemotherapy in Breast Cancer Patients and Its Effects on Neurocognition
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| General Physical Activity Recommendations | Procedure | — | UNRESOLVED |
| High-Intensity-Interval-Training | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: Exercise intervention arm
- interventionNames
- Procedure: High-Intensity-Interval-Training
- type
- PLACEBO_COMPARATOR
- label
- Arm B: Control arm
- interventionNames
- Procedure: General Physical Activity Recommendations
Primary outcomes (1)
- measure
- Cognition
- timeFrame
- 12 month
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKiesl 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