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

Not Applicable

Completed

• Conditions: Malignant neoplasms of breast; Breast cancer; Cancer

• Registration Number: ISRCTN32617901
• Lead Sponsor: Centro Hospitalar de Vila Nova de Gaia

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31307527 protocol (added 17/07/2019) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36857149/ primary outcome results (added 03/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-24
• Study Completion: 2022-08-31
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 93

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

Current exclusion criteria as of 10/01/2019:
1. Contraindications to maximal exercise testing
2. Decompensated diabetes mellitus
3. Severe anaemia (<8 g/dl) uncorrectable with transfusion and/or iron and/or vitamin deficiency replacement
4. Significant heart disease (myocardial infarction, congestive heart failure, cardiomyopathy)
5. Usual medication containing beta-blockers
6. Contraindication to exercise

Previous exclusion criteria:
1. Heart failure class >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified