Effects of an exercise training program on cardiac health in women with breast cancer: the Mama Move Gaia on treatment trial

Conditions

Breast cancer Cancer Malignant neoplasms of breast

Helena Guedes, David João, Pedro Antunes, Sandra Silva, Inês Leão et al. (12 authors)

Journal of Clinical Oncology2023-06-011 citations

10.1200/jco.2023.41.16_suppl.e12596

Effects of exercise training on cardiac toxicity markers in women with breast cancer undergoing chemotherapy with anthracyclines: a randomized controlled trial

Pedro Antunes, Ana Joaquim, Francisco Sampaio, Célia Nunes, António Ascensão et al. (13 authors)

European Journal of Preventive Cardiology2023-02-2847 citations

10.1093/eurjpc/zwad063

Impact of exercise training on cardiotoxicity and cardiac health outcomes in women with breast cancer anthracycline chemotherapy: a study protocol for a randomized controlled trial.

Antunes P, Esteves D, Nunes C, Sampaio F, Ascensão A, Vilela E, Teixeira M, Amarelo AL, Joaquim A.

2019-07-1511 citations

10.1186/s13063-019-3499-9

Interventions

Patients will be randomised to either the intervention or the control group using a permutated block design with random four and six block sizes. Patients in the intervention group wil

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 10/01/2019: 1. Female 2. Aged 18 years or older 3. Histological confirmation of invasive breast cancer 4. Breast cancer stage IA-IIIC 5. Scheduled to receive neoadjuvant or adjuvant anthracycline-containing chemotherapy by decision of the Multidisciplinary Group Consultation of Centro Hospitalar de Vila Nova de Gaia/Espinho 6. Able to provide informed consent 7. Acceptance of randomization to intervention group or control group 8. Baseline assessments before anthracycline-containing chemotherapy begins. Previous inclusion criteria: 1. Female 2. Aged 18 years or older 3. Histological confirmation of invasive breast cancer 4. Breast cancer stage IA-IIIC 5. Scheduled to receive neoadjuvant or adjuvant anthracycline-containing chemotherapy and/or trastuzumab by the Multidisciplinary Group Consultation of Centro Hospitalar de Vila Nova de Gaia/Espinho decision 6. Able to provide informed consent 7. Acceptance of randomization to intervention group or control group

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 10/01/2019: 1. Contraindications to maximal exercise testing 2. Decompensated diabetes mellitus 3. Severe anaemia (1 of the New York Heart Association. 2. Osteoporosis (Tscore < 2.5) 3. Contraindications to maximal exercise testing 4. Usual medication containing beta-blockers 5. Severe anaemia (<8 g/dl) that cannot be corrected with transfusion and/or replacement of iron deficiency and/or vitamin deficiency

Design outcomes

Primary

Measure	Time frame
Current primary outcome measures as of 10/01/2019: 1. Cardiotoxicity markers: 1.1. Systolic function (left ventricular ejection fraction), assessed using standard transthoracic echocardiography at the baseline, at the end of treatment and 3 months afterwards 1.2. Myocardial deformation (global longitudinal strain), assessed using standard transthoracic echocardiography at the baseline, at the end of treatment and 3 months afterwards 1.3. Circulating cardiac biomarkers (amino-terminal pro-brain natriuretic peptide), assessed using blood samples at the baseline, 24 hours before the start of each treatment cycle, at the end of treatment and 3 months afterwards 2. Cardiac health outcomes will be assessed at the baseline, at the end of treatment and 3 months afterwards: 2.1. Resting blood pressure, measured in a seated comfortable position using a cardiac monitor 2.2. Resting heart rate, measured in a seated comfortable position using a cardiac monitor 2.3. Resting heart rate variability, measured in a seated comfortable position after at least 5 minutes of rest using a Polar V800 heart rate monitor with a Polar H7 Heart Rate Sensor chest strap. Analysis will be done using Kubios v2 Heart Rate Variability software. 2.4. Heart rate recovery (measured using a cardiac monitor after 30 seconds and 60 seconds after completion of a cardiopulmonary test), defined as the difference between peak heart rate achieved in the cardiopulmonary test and the heart rate at 30 seconds and 60 seconds following this. Previous primary outcome measures: 1. Cardiotoxicity markers: 1.1. Systolic function (left ventricular ejection fraction), assessed using standard transthoracic echocardiography at the baseline, at the end of treatment and 3 months afterwards 1.2. Myocardial deformation (gl	—

Measure

Time frame

Current primary outcome measures as of 10/01/2019: 1. Cardiotoxicity markers: 1.1. Systolic function (left ventricular ejection fraction), assessed using standard transthoracic echocardiography at the baseline, at the end of treatment and 3 months afterwards 1.2. Myocardial deformation (global longitudinal strain), assessed using standard transthoracic echocardiography at the baseline, at the end of treatment and 3 months afterwards 1.3. Circulating cardiac biomarkers (amino-terminal pro-brain natriuretic peptide), assessed using blood samples at the baseline, 24 hours before the start of each treatment cycle, at the end of treatment and 3 months afterwards 2. Cardiac health outcomes will be assessed at the baseline, at the end of treatment and 3 months afterwards: 2.1. Resting blood pressure, measured in a seated comfortable position using a cardiac monitor 2.2. Resting heart rate, measured in a seated comfortable position using a cardiac monitor 2.3. Resting heart rate variability, measured in a seated comfortable position after at least 5 minutes of rest using a Polar V800 heart rate monitor with a Polar H7 Heart Rate Sensor chest strap. Analysis will be done using Kubios v2 Heart Rate Variability software. 2.4. Heart rate recovery (measured using a cardiac monitor after 30 seconds and 60 seconds after completion of a cardiopulmonary test), defined as the difference between peak heart rate achieved in the cardiopulmonary test and the heart rate at 30 seconds and 60 seconds following this. Previous primary outcome measures: 1. Cardiotoxicity markers: 1.1. Systolic function (left ventricular ejection fraction), assessed using standard transthoracic echocardiography at the baseline, at the end of treatment and 3 months afterwards 1.2. Myocardial deformation (gl

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Secondary

Measure	Time frame
All secondary outcomes will be measured at the baseline, at the end of treatment and 3 months afterwards: 1. Functional outcomes: 1.1. Cardiopulmonary capacity (maximum oxygen consumption), evaluated using a Bruce treadmill test with an echocardiogram and continuous analysis of the O2/CO2 exchange 1.2. Upper limb strength (maximum voluntary handgrip strength), assessed using a handgrip dynamometer (6 trials per participant with 3 in each arm) 1.3. Lower limb functionality, assessed using the sit-stand test 2. Health-related quality of life and fatigue, assessed using the European Organization for Research and Treatment in Cancer Quality of Life C-30 (EORTC QLQ-C30) questionnaire 3. Neuropathy-related chemotherapy, assessed using The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group -Neurotoxicity (FACT/GOG-Ntx) Scale)	—

Measure

Time frame

All secondary outcomes will be measured at the baseline, at the end of treatment and 3 months afterwards: 1. Functional outcomes: 1.1. Cardiopulmonary capacity (maximum oxygen consumption), evaluated using a Bruce treadmill test with an echocardiogram and continuous analysis of the O2/CO2 exchange 1.2. Upper limb strength (maximum voluntary handgrip strength), assessed using a handgrip dynamometer (6 trials per participant with 3 in each arm) 1.3. Lower limb functionality, assessed using the sit-stand test 2. Health-related quality of life and fatigue, assessed using the European Organization for Research and Treatment in Cancer Quality of Life C-30 (EORTC QLQ-C30) questionnaire 3. Neuropathy-related chemotherapy, assessed using The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group -Neurotoxicity (FACT/GOG-Ntx) Scale)

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Countries

Portugal

Contacts

Public ContactPedro;Ana Antunes;Joaquim

;

pantunes_14@hotmail.com;969270946;

Outcome results

None listed