Breast CancerPhase 2NCT07162298
Dragon Boat Race Versus Family Unsupervised Training to Improve the Physical Function and Quality of Life in Breast Cancer Patients
A Phase 2 study testing Dragon Boat Training and Home-based Unsupervised Training in people with Breast Cancer, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dragon Boat Training and Home-based Unsupervised Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2025to 7 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to 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):
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhejiang University
Hangzhou
Zhijun Dai, Professor, +86 157 0581 9132, dzj0911@126.com
Youyi Chen Chen, 913589289@qq.com
About this study
Official title: 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
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
- Conditions
- Breast Cancer
- Being tested
- Dragon Boat Training, Home-based Unsupervised Training
- Keywords
- Breast cancer, Post-operation, Dragon Boat Race, Physical function, Quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dragon Boat TrainingOther
The total training duration is 12 weeks, divided into cycles of 4 weeks each, with distinct training contents and goals for every cycle. Training sessions are held 3 times a week, and all participants train together on the same day. Each training session lasts approximately 60 minutes.
In the first 4 weeks, participants spend half an hour training on land and the subsequent half an hour training on dragon boats.
Then, from week 4 to week 8, they train for 20 minutes on land and 40 minutes on dragon boats.
Finally, from week 8 to week 12, they only conduct 10-15 minutes of land training (as warm-up) followed by nearly an hour of on-boat training.
This progressive training plan is designed to ensure that each participant can tolerate the training intensity as much as possible, preventing injuries caused by training.
Home-based Unsupervised TrainingOther
The total training duration is 12 weeks. After a 15-minute warm-up (including walking, exercises, etc.), participants will perform the following 10 movements in sequence: squats, rowing simulation with rubber bands, lateral raises, sit-ups, shoulder presses, alternating bilateral lunges, dumbbell curls (for biceps), sit-ups, and planks.
Each movement lasts 60 seconds, with a 10-second rest allowed midway through the same movement (i.e., 15 seconds of exercise followed by a 10-second rest, then another 15 seconds to complete the movement). A 20-second rest is permitted before moving on to the next movement.
Once participants can complete 30 seconds of the same movement without needing rest or adjustment, the training intensity will be increased-progressing from one round of training (10 minutes) to two rounds (20 minutes) or even three rounds (30 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Dragon Boat Training Group (DB) | Experimental | The total training duration is 12 weeks, divided into cycles of 4 weeks each, with distinct training contents and goals for every cycle. Training sessions are held 3 times a week, and all participants train together on the same day. Each training session lasts approximately 60 minutes.
In the first 4 weeks, participants spend half an hour training on land and the subsequent half an hour training on dragon boats.
Then, from week 4 to week 8, they train for 20 minutes on land and 40 minutes on dragon boats.
Finally, from week 8 to week 12, they only conduct 10-15 minutes of land training (as warm-up) followed by nearly an hour of on-boat training.
This progressive training plan is designed to ensure that each participant can tolerate the training intensity as much as possible, preventing injuries caused by training. Receives: Other: Dragon Boat Training |
| Home-based Unsupervised Training Group (HG) | Active comparator | The total training duration is 12 weeks. After a 15-minute warm-up (including walking, exercises, etc.), participants will perform the following 10 movements in sequence: squats, rowing simulation with rubber bands, lateral raises, sit-ups, shoulder presses, alternating bilateral lunges, dumbbell curls (for biceps), sit-ups, and planks.
Each movement lasts 60 seconds, with a 10-second rest allowed midway through the same movement (i.e., 15 seconds of exercise followed by a 10-second rest, then another 15 seconds to complete the movement). A 20-second rest is permitted before moving on to the next movement.
Once participants can complete 30 seconds of the same movement without needing rest or adjustment, the training intensity will be increased-progressing from one round of training (10 minutes) to two rounds (20 minutes) or even three rounds (30 minutes). Receives: Other: Home-based Unsupervised Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI (kg/m²)
BMI (kg/m²) weight and height will be combined to report BMI in kg/m^2
Measured: 1 year
Secondary outcomes (2)
Physical function
Six-minute walk test (6MWT, m)：The test is conducted in an indoor, long, straight, and flat rectangular area with a 30-meter walking route, where participants walk back and forth repeatedly. They should walk at their usual pace and rhythm as much as possible, without the need for brisk walking or jogging. The distance walked by the participants after 6 minutes is recorded. The formula reported by Enright and Sherrill, which is based on body mass index (BMI) and age, is used to compare with the 6-minute walk distance (6MWD) of normal healthy populations (for males: 6MWD (m) = 1140m - 5.61 × BMI (kg/m²) - 6.94 × age (years); for females: 6MWD (m) = 1017m - 6.24 × BMI (kg/m²) - 5.83 × age (years)).
Measured: 1 year
Psychological status
Self-report measurement method used to assess people's acceptance of their own bodies, respect and care for their bodies, and protection of their bodies from unrealistic beauty standards. All items are rated on a 5-point scale (1 = never, 5 = always), and the total score is calculated as the average of all items, so a higher score reflects a higher level of body appreciation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start7 Apr 2025
- Primary completion7 Apr 2026 (estimated)
- Study completion7 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162298
- Sponsor's protocol ID
- IIT20250005C
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07162298
- Acronym / sponsor ID
- IIT20250005C
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Post-operation, Dragon Boat Race, Physical function, Quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 7 Apr 2026 (estimated)
- Study completion
- 7 Apr 2028 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dragon Boat Training Group (DB) | Experimental | Other: Dragon Boat TrainingThe total training duration is 12 weeks, divided into cycles of 4 weeks each, with distinct training contents and goals for every cycle. Training sessions are held 3 times a week, and all participants train together on the same day. Each training session lasts approximately 60 minutes. In the first 4 weeks, participants spend half an hour training on land and the subsequent half an hour training on dragon boats. Then, from week 4 to week 8, they train for 20 minutes on land and 40 minutes on dragon boats. Finally, from week 8 to week 12, they only conduct 10-15 minutes of land training (as warm-up) followed by nearly an hour of on-boat training. This progressive training plan is designed to ensure that each participant can tolerate the training intensity as much as possible, preventing injuries caused by training. |
| Home-based Unsupervised Training Group (HG) | Active comparator | Other: Home-based Unsupervised TrainingThe total training duration is 12 weeks. After a 15-minute warm-up (including walking, exercises, etc.), participants will perform the following 10 movements in sequence: squats, rowing simulation with rubber bands, lateral raises, sit-ups, shoulder presses, alternating bilateral lunges, dumbbell curls (for biceps), sit-ups, and planks. Each movement lasts 60 seconds, with a 10-second rest allowed midway through the same movement (i.e., 15 seconds of exercise followed by a 10-second rest, then another 15 seconds to complete the movement). A 20-second rest is permitted before moving on to the next movement. Once participants can complete 30 seconds of the same movement without needing rest or adjustment, the training intensity will be increased-progressing from one round of training (10 minutes) to two rounds (20 minutes) or even three rounds (30 minutes). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dragon Boat TrainingThe total training duration is 12 weeks, divided into cycles of 4 weeks each, with distinct training contents and goals for every cycle. Training sessions are held 3 times a week, and all participants train together on the same day. Each training session lasts approximately 60 minutes. In the first 4 weeks, participants spend half an hour training on land and the subsequent half an hour training on dragon boats. Then, from week 4 to week 8, they train for 20 minutes on land and 40 minutes on dragon boats. Finally, from week 8 to week 12, they only conduct 10-15 minutes of land training (as warm-up) followed by nearly an hour of on-boat training. This progressive training plan is designed to ensure that each participant can tolerate the training intensity as much as possible, preventing injuries caused by training. | Other | Dragon Boat Training Group (DB) |
| Home-based Unsupervised TrainingThe total training duration is 12 weeks. After a 15-minute warm-up (including walking, exercises, etc.), participants will perform the following 10 movements in sequence: squats, rowing simulation with rubber bands, lateral raises, sit-ups, shoulder presses, alternating bilateral lunges, dumbbell curls (for biceps), sit-ups, and planks. Each movement lasts 60 seconds, with a 10-second rest allowed midway through the same movement (i.e., 15 seconds of exercise followed by a 10-second rest, then another 15 seconds to complete the movement). A 20-second rest is permitted before moving on to the next movement. Once participants can complete 30 seconds of the same movement without needing rest or adjustment, the training intensity will be increased-progressing from one round of training (10 minutes) to two rounds (20 minutes) or even three rounds (30 minutes). | Other | Home-based Unsupervised Training Group (HG) |
Primary outcome
BMI (kg/m²)
Time frame: 1 year
BMI (kg/m²) weight and height will be combined to report BMI in kg/m^2
2 secondary outcomes
Physical function
Time frame: 1 year
Psychological status
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dragon Boat Training and Home-based Unsupervised Training in people with Breast Cancer, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhijun Dai Professor (+86 157 0581 9132, dzj0911@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (kg/m²) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.