BridgeMD
Compares treatment options for Breast Cancer
Official title Dragon Boat Race Versus Family Unsupervised Training to Improve the Physical Function and Quality of Life in Breast Cancer Patients
ClinicalTrials.gov ID: NCT07162298
What this study is testing
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- 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;
You likely can't join if
- 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...
- Concurrent receipt of anti-tumor therapy in other clinical trials, including but not limited to chemotherapy, endocrine therapy, biological 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:
See the full eligibility criteria
Who can join
- 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...
- 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...
- Voluntary participation in the study, signing of informed consent, good compliance, and willingness to cooperate with follow-up.
What rules you out
- 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...
- 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 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.