NCT07162298招募中2 期
A Randomized, Open, Single Center Clinical Study of Dragon Boat Race Versus Family Unsupervised Training to Improve the Physical Function and Quality of Life in Breast Cancer Patients
First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年4月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- BMI (kg/m²)
研究概览
简要总结
Investigators plans to conduct a randomized, open, single center clinical study of Dragon Boat Race versus family unsupervised training to improve the physical function and quality of life in breast cancer patients to compare the effects of organized and supervised short-term dragon boat training versus unsupervised home training on body composition, physical function, and quality of life in women after breast cancer surgery. Participants will be assigned to the following intervention protocols at a 1:1 ratio:Dragon Boat Training Group (DB): Conduct 12-week dragon boat training under the guidance of professional coaches.Home-based Unsupervised Training Group (HG): Perform exercises at home independently according to instructional videos for 12 weeks.The primary outcomes are to analyze differences in body composition, physical function, and quality of life.The secondary exploratory outcomes include stratified factors such as menopausal status and surgical methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-75 years;
- •ECOG performance status of 0-1;
- •BMI between 18.0 and 30.0;
- •No prior experience with dragon boat or kayaking;
- •Histologically or pathologically confirmed invasive breast cancer;
- •Function levels of major organs must meet the following requirements (no blood transfusion, no use of leukocyte-elevating or platelet-elevating drugs within 2 weeks before screening):
- •Routine blood test: absolute neutrophil count (ANC) > 1.5×10⁹/L; platelet count (PLT) > 75×10⁹/L; hemoglobin (Hb) > 90g/L; lymphocyte count ≥ 1.5×10⁹/L.
- •Blood biochemistry: total bilirubin (TBIL) < 1.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 1.5×ULN; alkaline phosphatase < 2.5×ULN; blood urea nitrogen/urea (BUN/UREA) and creatinine (Cr) < 1.5×ULN.
- •Echocardiography: left ventricular ejection fraction (LVEF) > 55%.
- •12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) < 470 msec. For premenopausal female patients or those not surgically sterilized: effective contraceptive methods must be used during treatment and for at least 6 months after the last dose in the study treatment.
- •Voluntary participation in the study, signing of informed consent, good compliance, and willingness to cooperate with follow-up.
排除标准
- •Stage IV breast cancer.
- •Inflammatory breast cancer.
- •Previous receipt of anti-tumor therapy or radiotherapy for any malignant tumor, excluding cured malignant tumors such as carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma.
- •Concurrent receipt of anti-tumor therapy in other clinical trials, including but not limited to chemotherapy, endocrine therapy, biological therapy, bone-modifying agent therapy, or immune checkpoint inhibitor therapy.
- •Previous regular participation in physical activity (moderate to vigorous exercise at least twice a week).
- •Severe heart disease or discomfort, including but not limited to the following conditions:
- •Confirmed history of heart failure or systolic dysfunction (LVEF less than 50%).
- •High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate greater than 100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or higher-grade atrioventricular block (i.e., Mobitz II second-degree atrioventricular block or third-degree atrioventricular block).
- •Angina pectoris requiring anti-anginal medication.
- •Clinically significant valvular heart disease.
- •ECG showing transmural myocardial infarction.
- •Poorly controlled hypertension (systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 100 mmHg after drug treatment).
- •Uncontrolled active infection requiring treatment; history of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- •Patients with active chronic hepatitis B or active hepatitis C (excluding hepatitis B virus carriers, hepatitis B patients stable after drug treatment [HBV-DNA test negative or < 50 IU/ml], and cured hepatitis C patients [HCV RNA test negative]).
- •Patients with any other chronic diseases (such as hypertension, diabetes, coronary heart disease, COPD, etc.).
- •Patients unable to tolerate moderate to vigorous exercise.
- •Pregnant or lactating female patients, female patients with childbearing potential and positive baseline pregnancy test, or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial and within 6 months after the last study medication.
- •Patients with severe concomitant diseases or other comorbidities that would interfere with the planned treatment, or any other conditions deemed by the researcher to make the patient unsuitable for participation in the study.
结局指标
主要结局
BMI (kg/m²)
时间窗: 1 year
BMI (kg/m²) weight and height will be combined to report BMI in kg/m\^2
次要结局
- Physical function(1 year)
- Physical function(1 year)
- Psychological status(1 year)
研究者
研究点 (1)
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