ISRCTN32617901已完成未知
Effects of supervised physical exercise on cardiotoxicity and cardiac health in women breast cancer survivors during anthracycline-containing chemotherapy: a randomised controlled trial
Centro Hospitalar de Vila Nova de Gaia0 个研究点目标入组 93 人开始时间: 2018年10月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 93
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 10/01/2019:
- •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:
- •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
排除标准
- •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
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