Evaluation of heart function after physical activity during adjuvant chemotherapy in breast cancer patients: a follow-up study of two previous randomized controlled trials.

Evaluation of heart function after physical activity during adjuvant chemotherapy in breast cancer patients: a follow-up study of two previous randomized controlled trials. - Pact-paces-heart study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50246

Enrollment

182

Registered

2018-05-15

Start date

2018-09-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiotoxicity damage to the heart

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - All eligible breast cancer participants of the previous PACT and PACES study. , PACT: physical activity during cancer treatment PACES: physical activity during adjuvant chemotherapy effectiveness study

Exclusion criteria

Exclusion criteria: - Participants who died during follow-up - Participants who are not considered eligible by their treating physician, based on psychological or physiological contraindications. - Participants treated with systemic therapy or thoracic radiotherapy after the completion of the original PACT and PACES study for recurrent breast cancer, including contralateral breast cancer. - Participants treated with systemic therapy or thoracic radiotherapy after the completion of the original PACT and PACES study for other malignancies than breast cancer, excluding non-melanoma skin-cancer.

Design outcomes

Primary

Measure	Time frame
Our primary outcome will be the difference in increased extracellular volume fraction (ECV) between patients who have participated in a moderate- to high-intensity supervise exercise program (intervention group of PACT and the On-Track program of PACES) during adjuvant chemotherapy compared to a combined control group of PACT and PACES.	—

Secondary

Measure	Time frame
- Left ventricular parameters, other than ECV, measured by CMR - Right ventricular parameters, measured by CMR - Left and right atrial function and geometry measured by CMR - Resting echocardiogram parameters of left and right ventricular function - Post-exercise echocardiogram parameters of left and right ventricular function - Cardiopulmonary exercise testing parameters - Parameters of endothelial function, measured by the EndoPAT - Muscle strength - Quality of life, anxiety and depression and fatigue - Biochemical measurements - Cognitive functioning - Heart rate variability - Physical activity	—

Measure

Time frame

- Left ventricular parameters, other than ECV, measured by CMR - Right ventricular parameters, measured by CMR - Left and right atrial function and geometry measured by CMR - Resting echocardiogram parameters of left and right ventricular function - Post-exercise echocardiogram parameters of left and right ventricular function - Cardiopulmonary exercise testing parameters - Parameters of endothelial function, measured by the EndoPAT - Muscle strength - Quality of life, anxiety and depression and fatigue - Biochemical measurements - Cognitive functioning - Heart rate variability - Physical activity

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Countries

Netherlands

Outcome results