Dragon boat training versus home exercise to improve function and quality of life after breast cancer surgery

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

This study will test whether organized, supervised dragon boat training or unsupervised home exercise better improves physical function and quality of life in women after breast cancer surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hangzhou)
• Trial ID: NCT07162298 on ClinicalTrials.gov

What this trial studies

This is a randomized, open-label, single-center phase 2 trial comparing 12 weeks of supervised dragon boat training led by professional coaches with 12 weeks of home-based unsupervised exercise delivered by instructional videos. Participants are assigned 1:1 to the dragon boat group or the home training group and undergo baseline and follow-up assessments of body composition, physical function, and quality of life. The primary outcomes compare changes in body composition, objective physical function measures, and patient-reported quality of life; secondary exploratory analyses will examine effects by menopausal status and surgical methods. Eligible participants are women aged 18–75 with histologically confirmed invasive breast cancer who meet prespecified performance status, BMI, and organ-function criteria.

Who should consider this trial

Good fit: Women aged 18–75 who have undergone surgery for invasive breast cancer, have ECOG 0–1, BMI 18.0–30.0, no prior dragon boat/kayak experience, and meet the study's laboratory, cardiac, and organ-function requirements are ideal candidates.

Not a fit: Patients with significant cardiac or organ dysfunction, those outside the age or BMI criteria, or those unable to attend supervised sessions or perform the exercise safely may not receive benefit from the interventions tested.

Why it matters

Potential benefit: If successful, the program could lead to improved body composition, physical function, and quality of life for women recovering from breast cancer surgery.

How similar studies have performed: Community-based dragon boat paddling programs for breast cancer survivors have previously shown improvements in upper-limb function and quality of life, but randomized comparisons against unsupervised home exercise are limited.

Eligibility criteria

Inclusion Criteria:

* 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):

  1. 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.
  2. 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.
  3. Echocardiography: left ventricular ejection fraction (LVEF) \> 55%.
  4. 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.

Exclusion Criteria:

* 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.

Where this trial is running

Hangzhou

• The First Affiliated Hospital of Zhejiang University — Hangzhou, China (Recruiting)

Study contacts

• Study coordinator: Zhijun Dai Professor

Conditions Breast Cancer; Breast cancer; Post-operation; Dragon Boat Race; Physical function; Quality of life