Breast CancerNCT07262099
Study of Effects of Dao-yin Exercise on the Patients With Breast Cancer Post Operation and Receiving Adjuvant Chemotherapy
A study testing Shangshou Dao-yin in people with Breast Cancer, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
This is a retrospective registration of a study that evaluated whether a traditional Dao-yin (mind-body exercise), called Shangshou Dao-yin, could improve sleep quality, Chinese medicine body constitution, and quality of life in breast cancer patients receiving adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 20 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Shangshou Dao-yin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Jan 2017to 8 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed Stage I, II, or III breast cancer with surgical tumor removal followed by adjuvant chemotherapy.
- Age ≥ 20 years.
- Ability to walk independently without movement restrictions.
- Able to communicate in Mandarin or Taiwanese.
- Provided written informed consent.
Who cannot join
- Regularly practicing Tai Chi or other mind-body exercises at the time of enrollment.
- Pre-existing chronic illnesses or symptoms that may interfere with evaluation of chemotherapy-related side effects (e.g., chronic diarrhea, neuropathy, heart failure, thromboembolic disease, chronic pulmonary or renal disease, alopecia).
- Pregnancy.
- Severe psychiatric illness (e.g., schizophrenia, major depressive disorder).
Trial locations and contacts
1 site in 1 country.
About this study
This is a retrospective registration of a study that evaluated whether a traditional Dao-yin (mind-body exercise), called Shangshou Dao-yin, could improve sleep quality, Chinese medicine body constitution, and quality of life in breast cancer patients receiving adjuvant chemotherapy.
A total of 327 postoperative breast cancer patients completed baseline questionnaires. Among them, 150 eligible participants entered the trial and were assigned to either a Dao-yin exercise group (72 participants) or a control group (78 participants) based on their preference. The exercise group practiced 20 minutes of Shangshou Dao-yin daily throughout chemotherapy, while the control group received standard care only. After withdrawals, 138 participants completed the final evaluation (66 in the Dao-yin group and 72 in the control group).
Sleep quality, body constitution (BCQ), quality of life (EORTC), and chemotherapy-related adverse effects were assessed during treatment and three weeks after chemotherapy completion. The findings may help determine whether Shangshou Dao-yin can reduce sleep disturbance and enhance well-being during cancer treatment.
Read the detailed description
Breast cancer remains one of the most prevalent malignant diseases among women, and many patients receiving adjuvant chemotherapy experience sleep disturbance, emotional distress, fatigue, and impaired quality of life.
Shangshou Dao-yin is a traditional Dao-yin (mind-body exercise) consists of eight techniques: Bouncing, Rotation, Swaying, Swinging, Wobble, Chopping, and Abdominal (diaphragmatic) Breathing. The core principle of the Shangshou Dao-yin method is to stimulate the lower dantian, the body's source of vital energy. Dao-yin emphasizes mental focus, natural breathing, and smooth, continuous movements that follow the body's structure to harmonize internal energy flow. It requires no equipment and minimal space, making it particularly suitable for patients during chemotherapy.
This retrospective registration describes a study that evaluated whether Shangshou Dao-yin could improve sleep quality, Chinese medicine body constitution, and health-related quality of life in breast cancer patients undergoing adjuvant chemotherapy. The study was approved by the Institutional Review Board of Tri-Service General Hospital (TSGHIRB-1-105-05-045) and was conducted between January 2017 and October 2019.
A total of 327 postoperative breast cancer patients completed baseline questionnaires. Among them, 150 eligible participants entered the trial and were assigned, based on preference, to either a Shangshou Dao-yin group (n = 72) or a control group (n = 78). The Dao-yin group practiced 20 minutes of Shangshou Dao-yin daily throughout chemotherap. A standardized instructional video, provided on DVD and through online streaming (e.g., YouTube) in collaboration with the Taiwan Society of Health Promotion. The control group received standard care only. After withdrawals, 138 participants (66 Dao-yin, 72 control) completed the final evaluation.
Data collection included baseline characteristics (age, sex, height, weight, marital status, education level, smoking and alcohol history, medical history, family history, pregnancy and childbirth history, food or drug allergies, and comorbidities). Cancer-related variables included TNM stage, surgical method, tumor histology, differentiation, hormone receptor status, and HER2 expression. Chemotherapy-related information included regimen, dosage, treatment cycles, dose modifications, delays, and completion of planned cycles.
Multiple clinical assessments were performed. Sleep quality was measured using the Chinese version of the Pittsburgh Sleep Quality Index (PSQI). Chinese medicine body constitution was assessed using the 44-item Body Constitution Questionnaire (BCQ), which measures Yang-Xu, Yin-Xu, and Stasis constitutions. Health-related quality of life was evaluated using the EORTC QLQ-C30 and QLQ-BR23. Psychological status was measured using the Beck Anxiety Inventory (BAI) and Beck Depression Inventory-II (BDI-II). Laboratory monitoring included white blood cell count, granulocyte and lymphocyte percentages, platelet count, hemoglobin, liver and kidney function tests, and electrolytes.
Chemotherapy-related adverse effects were documented according to the Common Terminology Criteria for Adverse Events (CTCAE v4.0), including hematologic changes, infection, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal bloating), mucositis, neuropathy, skin pigmentation, and insomnia. Medication use was recorded, including supportive drugs for chemotherapy side effects, chronic disease medications, and complementary therapies such as Chinese herbal medicine or special diets. Unscheduled outpatient visits, emergency department visits, hospitalizations, and physician-directed management of serious toxicities (dose reduction, treatment delay, or discontinuation) were also documented.
Assessments were performed before chemotherapy, at scheduled 4 time points during treatment, and three weeks after completion of chemotherapy. This study may help determine whether a traditional mind-body exercise can be feasibly implemented as a supportive care strategy for breast cancer patients undergoing chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- Shangshou Dao-yin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shangshou Dao-yinBehavioural
Participants practiced Shangshou Dao-yin, a traditional Daoist mind-body exercise consisting of eight techniques: Bouncing, Rotation, Swaying, Swinging, Wobble, Chopping, and Abdominal (diaphragmatic) Breathing. The exercise features gentle, rhythmic movements combined with natural breathing and mental focus, and requires no equipment or special space, making it suitable for patients undergoing chemotherapy. A standardized instructional video, provided on DVD and through online streaming (e.g., YouTube), was used to guide self-practice. Participants performed 20 minutes of Shangshou Dao-yin per day throughout the entire course of adjuvant chemotherapy, either at home or in the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Shangshou Dao-yin Group | Experimental | Participants practiced Shangshou Dao-yin, a traditional mind-body exercise, for 20 minutes daily throughout the course of adjuvant chemotherapy. A standardized instructional video was provided to guide home or hospital practice. Receives: Behavioral: Shangshou Dao-yin |
| Control Group | No intervention | Participants received standard medical care during chemotherapy without any structured exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health-Related Quality of Life (EORTC Quality of Life Questionnaire-Core 30; QLQ-C30)
Quality of life was assessed using the EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30). Scores were transformed to 0-100 scales, with higher functional scores indicating better functioning and higher symptom scores indicating worse symptoms.
Score Range: 0-100 Directionality: Higher = better (function scales); Higher = worse (symptom scales)
Measured: Baseline to 3 weeks after completion of chemotherapy
Change in Breast Cancer-Specific Quality of Life (EORTC Breast Cancer-Specific Quality of Life Questionnaire; QLQ-BR23)
Breast cancer-specific quality of life was measured using the EORTC Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23). All subscales were transformed to 0-100 scales, with higher functional scores indicating better functioning and higher symptom scores indicating worse symptoms.
Score Range: 0-100 Directionality: Higher = better (function scales); Higher = worse (symptom scales)
Measured: Baseline to 3 weeks after completion of chemotherapy
Secondary outcomes (2)
Change in Body Constitution (Body Constitution Questionnaire; BCQ)
Body constitution was assessed using the Body Constitution Questionnaire (BCQ), a 44-item instrument scored on a 1-5 Likert scale evaluating Yang-Xu, Yin-Xu, and Stasis constitutions. Higher scores indicate greater deviation from a balanced (neutral) constitution.
Score Range: 44-220 (total possible score range across 44 items scored 1-5) Directionality: Higher = worse (greater imbalance)
Measured: Baseline to 3 weeks after completion of chemotherapy
Chemotherapy-related Adverse Events (CTCAE v4.0)
Chemotherapy toxicities were documented according to the Common Terminology Criteria for Adverse Events (CTCAE v4.0), including hematologic changes, gastrointestinal symptoms, mucositis, neuropathy, skin reactions, and infection.
Measured: Baseline to 3 weeks after completion of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start13 Jan 2017
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
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.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chien-Jung Lin, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262099
- Sponsor's protocol ID
- TSGH-C106-020
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Effects of Dao-yin Exercise on the Patients With Breast Cancer Post Operation and Receiving Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT07262099
- Acronym / sponsor ID
- TSGH-C106-020
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 13 Jan 2017 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 3 Dec 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.
This is a retrospective registration of a study that evaluated whether a traditional Dao-yin (mind-body exercise), called Shangshou Dao-yin, could improve sleep quality, Chinese medicine body constitution, and quality of life in breast cancer patients receiving adjuvant chemotherapy.
A total of 327 postoperative breast cancer patients completed baseline questionnaires. Among them, 150 eligible participants entered the trial and were assigned to either a Dao-yin exercise group (72 participants) or a control group (78 participants) based on their preference. The exercise group practiced 20 minutes of Shangshou Dao-yin daily throughout chemotherapy, while the control group received standard care only. After withdrawals, 138 participants completed the final evaluation (66 in the Dao-yin group and 72 in the control group).
Sleep quality, body constitution (BCQ), quality of life (EORTC), and chemotherapy-related adverse effects were assessed during treatment and three weeks after chemotherapy completion. The findings may help determine whether Shangshou Dao-yin can reduce sleep disturbance and enhance well-being during cancer treatment.
Detailed description
Breast cancer remains one of the most prevalent malignant diseases among women, and many patients receiving adjuvant chemotherapy experience sleep disturbance, emotional distress, fatigue, and impaired quality of life.
Shangshou Dao-yin is a traditional Dao-yin (mind-body exercise) consists of eight techniques: Bouncing, Rotation, Swaying, Swinging, Wobble, Chopping, and Abdominal (diaphragmatic) Breathing. The core principle of the Shangshou Dao-yin method is to stimulate the lower dantian, the body's source of vital energy. Dao-yin emphasizes mental focus, natural breathing, and smooth, continuous movements that follow the body's structure to harmonize internal energy flow. It requires no equipment and minimal space, making it particularly suitable for patients during chemotherapy.
This retrospective registration describes a study that evaluated whether Shangshou Dao-yin could improve sleep quality, Chinese medicine body constitution, and health-related quality of life in breast cancer patients undergoing adjuvant chemotherapy. The study was approved by the Institutional Review Board of Tri-Service General Hospital (TSGHIRB-1-105-05-045) and was conducted between January 2017 and October 2019.
A total of 327 postoperative breast cancer patients completed baseline questionnaires. Among them, 150 eligible participants entered the trial and were assigned, based on preference, to either a Shangshou Dao-yin group (n = 72) or a control group (n = 78). The Dao-yin group practiced 20 minutes of Shangshou Dao-yin daily throughout chemotherap. A standardized instructional video, provided on DVD and through online streaming (e.g., YouTube) in collaboration with the Taiwan Society of Health Promotion. The control group received standard care only. After withdrawals, 138 participants (66 Dao-yin, 72 control) completed the final evaluation.
Data collection included baseline characteristics (age, sex, height, weight, marital status, education level, smoking and alcohol history, medical history, family history, pregnancy and childbirth history, food or drug allergies, and comorbidities). Cancer-related variables included TNM stage, surgical method, tumor histology, differentiation, hormone receptor status, and HER2 expression. Chemotherapy-related information included regimen, dosage, treatment cycles, dose modifications, delays, and completion of planned cycles.
Multiple clinical assessments were performed. Sleep quality was measured using the Chinese version of the Pittsburgh Sleep Quality Index (PSQI). Chinese medicine body constitution was assessed using the 44-item Body Constitution Questionnaire (BCQ), which measures Yang-Xu, Yin-Xu, and Stasis constitutions. Health-related quality of life was evaluated using the EORTC QLQ-C30 and QLQ-BR23. Psychological status was measured using the Beck Anxiety Inventory (BAI) and Beck Depression Inventory-II (BDI-II). Laboratory monitoring included white blood cell count, granulocyte and lymphocyte percentages, platelet count, hemoglobin, liver and kidney function tests, and electrolytes.
Chemotherapy-related adverse effects were documented according to the Common Terminology Criteria for Adverse Events (CTCAE v4.0), including hematologic changes, infection, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal bloating), mucositis, neuropathy, skin pigmentation, and insomnia. Medication use was recorded, including supportive drugs for chemotherapy side effects, chronic disease medications, and complementary therapies such as Chinese herbal medicine or special diets. Unscheduled outpatient visits, emergency department visits, hospitalizations, and physician-directed management of serious toxicities (dose reduction, treatment delay, or discontinuation) were also documented.
Assessments were performed before chemotherapy, at scheduled 4 time points during treatment, and three weeks after completion of chemotherapy. This study may help determine whether a traditional mind-body exercise can be feasibly implemented as a supportive care strategy for breast cancer patients undergoing chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shangshou Dao-yin Group | Experimental | Behavioral: Shangshou Dao-yinParticipants practiced Shangshou Dao-yin, a traditional mind-body exercise, for 20 minutes daily throughout the course of adjuvant chemotherapy. A standardized instructional video was provided to guide home or hospital practice. |
| Control Group | No intervention | –Participants received standard medical care during chemotherapy without any structured exercise intervention. |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed Stage I, II, or III breast cancer with surgical tumor removal followed by adjuvant chemotherapy.
- Age ≥ 20 years.
- Ability to walk independently without movement restrictions.
- Able to communicate in Mandarin or Taiwanese.
- Provided written informed consent.
Key exclusion criteria (4 listed)
- Regularly practicing Tai Chi or other mind-body exercises at the time of enrollment.
- Pre-existing chronic illnesses or symptoms that may interfere with evaluation of chemotherapy-related side effects (e.g., chronic diarrhea, neuropathy, heart failure, thromboembolic disease, chronic pulmonary or renal disease, alopecia).
- Pregnancy.
- Severe psychiatric illness (e.g., schizophrenia, major depressive disorder).
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 |
|---|---|---|
| Shangshou Dao-yinParticipants practiced Shangshou Dao-yin, a traditional Daoist mind-body exercise consisting of eight techniques: Bouncing, Rotation, Swaying, Swinging, Wobble, Chopping, and Abdominal (diaphragmatic) Breathing. The exercise features gentle, rhythmic movements combined with natural breathing and mental focus, and requires no equipment or special space, making it suitable for patients undergoing chemotherapy. A standardized instructional video, provided on DVD and through online streaming (e.g., YouTube), was used to guide self-practice. Participants performed 20 minutes of Shangshou Dao-yin per day throughout the entire course of adjuvant chemotherapy, either at home or in the hospital. | Behavioural | Shangshou Dao-yin Group |
Primary outcome
Change in Health-Related Quality of Life (EORTC Quality of Life Questionnaire-Core 30; QLQ-C30)
Time frame: Baseline to 3 weeks after completion of chemotherapy
Quality of life was assessed using the EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30). Scores were transformed to 0-100 scales, with higher functional scores indicating better functioning and higher symptom scores indicating worse symptoms. Score Range: 0-100 Directionality: Higher = better (function scales); Higher = worse (symptom scales)
Change in Breast Cancer-Specific Quality of Life (EORTC Breast Cancer-Specific Quality of Life Questionnaire; QLQ-BR23)
Time frame: Baseline to 3 weeks after completion of chemotherapy
Breast cancer-specific quality of life was measured using the EORTC Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23). All subscales were transformed to 0-100 scales, with higher functional scores indicating better functioning and higher symptom scores indicating worse symptoms. Score Range: 0-100 Directionality: Higher = better (function scales); Higher = worse (symptom scales)
2 secondary outcomes
Change in Body Constitution (Body Constitution Questionnaire; BCQ)
Time frame: Baseline to 3 weeks after completion of chemotherapy
Chemotherapy-related Adverse Events (CTCAE v4.0)
Time frame: Baseline to 3 weeks after completion of chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shangshou Dao-yin in people with Breast Cancer, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 12 Dec 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 Taiwan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health-Related Quality of Life (EORTC Quality of Life Questionnaire-Core 30; QLQ-C30) (time frame: Baseline to 3 weeks after completion of chemotherapy). The study lists 2 primary outcomes in all. 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 12 Dec 2025.