Breast CancerECCONCT04789187
Exercise, Cancer and Cognition: The ECCO-Study
A study testing High-Intensity-Interval-Training and General Physical Activity Recommendations in people with Breast Cancer, run by Johannes Kepler University of Linz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- High-Intensity-Interval-Training and General Physical Activity Recommendations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2019to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Kepler University Hospital
Linz, Upper Austria, 4020
David Kiesl, MD, +435768083 ext. 1610, david.kiesl@kepleruniklinikum.at
Milan R Vosko, MD, PhD, +43768083 ext. 6672, milan.vosko@kepleruniklinikum.at
About this study
Official title: Randomized Controlled Trial of Simultaneous Exercise During Neo-/Adjuvant Chemotherapy in Breast Cancer Patients and Its Effects on Neurocognition
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- High-Intensity-Interval-Training, General Physical Activity Recommendations
- Keywords
- Breast, Cancer, CRCI, Chemobrain, Cognition, Exercise, High-Intensity-Interval-Training
- Medical subject headings
- Breast Neoplasms, Neoplasms, Chemotherapy-Related Cognitive Impairment, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity-Interval-TrainingProcedure or surgery
Defined exercise program up to four times per week including high-intensity-interval-training for one year of active study intervention.
General Physical Activity RecommendationsProcedure or surgery
Patients will be given general physical activity recommendations during chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Exercise intervention arm | Active comparator | Not described Receives: Procedure: High-Intensity-Interval-Training |
| Arm B: Control arm | Placebo comparator | Not described Receives: Procedure: General Physical Activity Recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 month
Secondary outcomes (1)
Hippocampal Volume
Devation of hippocampal volume measured 12 months after baseline assessment.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Dec 2019
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Kepler University of Linz
- Sponsor type
- University, hospital or other
- Collaborators
- German Sport University, Cologne, University of Graz, Charite University, Berlin, Germany, Charles University, Czech Republic
- Responsible party
- Principal investigator, Milan Vosko, MD, PhD, Johannes Kepler University of Linz
- Investigators
- Milan R Vosko, MD, PhD, Study chair, Johannes Kepler University of Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789187
- Sponsor's protocol ID
- 1191/2018
- Acronym
- ECCO
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2020
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35401389
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Simultaneous Exercise During Neo-/Adjuvant Chemotherapy in Breast Cancer Patients and Its Effects on Neurocognition
- ClinicalTrials.gov ID
- NCT04789187
- Acronym / sponsor ID
- ECCO / 1191/2018
- Conditions
- Breast Cancer
- Keywords
- Breast, Cancer, CRCI, Chemobrain, Cognition, Exercise, High-Intensity-Interval-Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- Collaborators
- German Sport University, Cologne, University of Graz, Charite University, Berlin, Germany, Charles University, Czech Republic
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Arm A: Exercise intervention arm | Active comparator | Procedure: High-Intensity-Interval-Training |
| Arm B: Control arm | Placebo comparator | Procedure: General Physical Activity Recommendations |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity-Interval-TrainingDefined exercise program up to four times per week including high-intensity-interval-training for one year of active study intervention. | Procedure or surgery | Arm A: Exercise intervention arm |
| General Physical Activity RecommendationsPatients will be given general physical activity recommendations during chemotherapy. | Procedure or surgery | Arm B: Control arm |
Primary outcome
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.
1 secondary outcome
Hippocampal Volume
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Derived from this study: PubMed 35401389Kiesl 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milan R Vosko, MD, PhD study chair
Johannes Kepler University of Linz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity-Interval-Training and General Physical Activity Recommendations in people with Breast Cancer, run by Johannes Kepler University of Linz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Milan R Vosko, MD, PhD (+435768083 ext. 6672, milan.vosko@kepleruniklinikum.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04789187, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.