Breast CancerNCT06337214
TCM Therapy Program Impact on Breast Cancer Patients' Vital Energy
A study testing Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy in people with Breast Cancer and Neoplasm, Breast, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
The goal of this study is to evaluate the impact of the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" on patients with breast cancer who are currently undergoing conventional Western medical treatments in Taiwan. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Breast Cancer, Neoplasm, Breast, Patient Participation
- What is being tested?
- Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Mar 2024to 31 Dec 2025
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18 years and above and below 85 years, willing to voluntarily participate in the study.
- Diagnosed with malignant breast tumors, ICD-10: C50, by conventional medicine.
- Patients currently undergoing cancer treatment, including chemotherapy, radiotherapy, or targeted therapy.
Who cannot join
- Diagnosed solely with carcinoma in situ or benign tumors, including fibrocystic breast conditions, by conventional medicine.
- Patients regularly receiving Astragalus polysaccharide injections.
- Patients with a history of allergies to Traditional Chinese Medicine.
- Pregnant or breastfeeding women.
- Individuals with a drug addiction habit, including both narcotic and non-narcotic drugs.
- Any other situation where the participant is unable to cooperate (e.g., due to any factor that prevents participation, deemed unsuitable for participation by study staff, unwillingness to sign the consent form).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chung-Hua Hsu, MD. PhD contact
Taiwan1 site, 1 recruiting
- Recruiting
Taipei City Hospital
Taipei, 10845
Yu-Hsuan Tai, MD, +886918130891, daidayangisele@gmail.com,dbb02@tpech.gov.tw
About this study
Official title: A Holistic Medical Approach - The Effect of "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" on Breast Cancer Patients Undergoing Cancer Therapy
The goal of this study is to evaluate the impact of the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" on patients with breast cancer who are currently undergoing conventional Western medical treatments in Taiwan. The main questions it aims to answer are:
Can the "Traditional Chinese Medicine Therapy Program" alleviate symptoms experienced by breast cancer patients? Does the program improve the quality of life for breast cancer patients receiving Western medical treatments? How does the program contribute to the management of side effects associated with Western oncological therapies?
Read more
Participants will:
Engage in the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" provided by the Taiwan Compassionate Cancer Care Association.
Receive supportive and educational services, including auxiliary Chinese medicine treatment courses, lifestyle and health education, and psychological counseling.
This study seeks to integrate the concept of holistic healthcare, emphasizing coordinated care that encompasses physical, mental, and social aspects, into the treatment of breast cancer.
Read the detailed description
This study aims to evaluate whether the participation in Traditional Chinese Medicine (TCM) supportive therapy courses, specifically the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" combined with the use of the herbal formulation at Taipei City Hospital, can enhance the quality of life of breast cancer patients undergoing treatment, increase their understanding and satisfaction with TCM adjunctive treatments, and bolster their confidence in cancer recovery.
This study adopts a holistic healthcare approach, integrating the Traditional Chinese Medicine (TCM) formulation Kuan-Sin-Yin from Taipei City Hospital with the "TCM Therapy Program for Reinforcing Vital Energy" course offered by a cancer patient support organization, to research its effects on breast cancer patients undergoing conventional medical treatment. International standard questionnaires and other inquiries are utilized to evaluate the impact on patients' physical, emotional, spiritual, and social well-being.
- Being tested
- Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy
- Keywords
- Breast Cancer, Reinforcing Vital Energy, Patients Association, Patients Educatioin
- Medical subject headings
- Breast Neoplasms, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese Medicine Therapy Program for Reinforcing Vital EnergyBehavioural
Comparing cancer patients who have participated in the program with those who have not, this study will examine differences in two types of quality of life questionnaires and constitution between the two groups.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy | Experimental | This study aims to evaluate whether the participation in Traditional Chinese Medicine (TCM) supportive therapy courses, specifically the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" , can enhance the quality of life of breast cancer patients undergoing treatment, increase their understanding and satisfaction with TCM adjunctive treatments, and bolster their confidence in cancer recovery. Evaluations will be conducted using pre- and post-tests spaced 4 to 6 weeks apart, during which participants will be administered three questionnaires. Receives: Behavioral: Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire: Constitution in Chinese Medicine Questionnaire
Observation and analysis Traditional Chinese Medicine Constitutions in breast cancer undergoing treatment
Measured: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks
Questionnaire: Functional Assessment of Cancer Therapy-General Scale, FACT-G)(Version 4)
Observation and analysis to measure four domains of QoL in cancer patients: Physical, social, emotional, and functional well-being
Measured: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks
Questionnaire: European Organisation for Research and Treatment of Cancer, EORTC QLQ-BR23)
Observation and analysis for measuring the quality of life in patients with breast cancer
Measured: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks
Secondary outcomes (1)
Additional questions regarding the "Traditional Chinese Medicine Program for Reinforcing Vital Energy"
Understanding and Course satisfaction and Confidence in cancer recovery
Measured: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start13 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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.
- 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chung-Hua Hsu, Taipei City Hospital
- Investigators
- Chung-Hua Hsu, MD. PhD, Study director, Linsen, Chinese Medicine and Kunming Branch, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337214
- Sponsor's protocol ID
- TCHIRB-11301014-E
- Status last verified
- May 2025
- First submitted
- 23 Mar 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Holistic Medical Approach - The Effect of "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" on Breast Cancer Patients Undergoing Cancer Therapy
- ClinicalTrials.gov ID
- NCT06337214
- Acronym / sponsor ID
- TCHIRB-11301014-E
- Keywords
- Breast Cancer, Reinforcing Vital Energy, Patients Association, Patients Educatioin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Mar 2024 (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.
The goal of this study is to evaluate the impact of the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" on patients with breast cancer who are currently undergoing conventional Western medical treatments in Taiwan. The main questions it aims to answer are:
Can the "Traditional Chinese Medicine Therapy Program" alleviate symptoms experienced by breast cancer patients? Does the program improve the quality of life for breast cancer patients receiving Western medical treatments? How does the program contribute to the management of side effects associated with Western oncological therapies?
Participants will:
Engage in the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" provided by the Taiwan Compassionate Cancer Care Association.
Receive supportive and educational services, including auxiliary Chinese medicine treatment courses, lifestyle and health education, and psychological counseling.
This study seeks to integrate the concept of holistic healthcare, emphasizing coordinated care that encompasses physical, mental, and social aspects, into the treatment of breast cancer.
Detailed description
This study aims to evaluate whether the participation in Traditional Chinese Medicine (TCM) supportive therapy courses, specifically the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" combined with the use of the herbal formulation at Taipei City Hospital, can enhance the quality of life of breast cancer patients undergoing treatment, increase their understanding and satisfaction with TCM adjunctive treatments, and bolster their confidence in cancer recovery.
This study adopts a holistic healthcare approach, integrating the Traditional Chinese Medicine (TCM) formulation Kuan-Sin-Yin from Taipei City Hospital with the "TCM Therapy Program for Reinforcing Vital Energy" course offered by a cancer patient support organization, to research its effects on breast cancer patients undergoing conventional medical treatment. International standard questionnaires and other inquiries are utilized to evaluate the impact on patients' physical, emotional, spiritual, and social well-being.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy | Experimental | Behavioral: Traditional Chinese Medicine Therapy Program for Reinforcing Vital EnergyThis study aims to evaluate whether the participation in Traditional Chinese Medicine (TCM) supportive therapy courses, specifically the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" , can enhance the quality of life of breast cancer patients undergoing treatment, increase their understanding and satisfaction with TCM adjunctive treatments, and bolster their confidence in cancer recovery. Evaluations will be conducted using pre- and post-tests spaced 4 to 6 weeks apart, during which participants will be administered three questionnaires. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals aged 18 years and above and below 85 years, willing to voluntarily participate in the study.
- Diagnosed with malignant breast tumors, ICD-10: C50, by conventional medicine.
- Patients currently undergoing cancer treatment, including chemotherapy, radiotherapy, or targeted therapy.
Key exclusion criteria (6 listed)
- Diagnosed solely with carcinoma in situ or benign tumors, including fibrocystic breast conditions, by conventional medicine.
- Patients regularly receiving Astragalus polysaccharide injections.
- Patients with a history of allergies to Traditional Chinese Medicine.
- Pregnant or breastfeeding women.
- Individuals with a drug addiction habit, including both narcotic and non-narcotic drugs.
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 |
|---|---|---|
| Traditional Chinese Medicine Therapy Program for Reinforcing Vital EnergyComparing cancer patients who have participated in the program with those who have not, this study will examine differences in two types of quality of life questionnaires and constitution between the two groups. | Behavioural | Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy |
Primary outcome
Questionnaire: Constitution in Chinese Medicine Questionnaire
Time frame: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks
Observation and analysis Traditional Chinese Medicine Constitutions in breast cancer undergoing treatment
Questionnaire: Functional Assessment of Cancer Therapy-General Scale, FACT-G)(Version 4)
Time frame: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks
Observation and analysis to measure four domains of QoL in cancer patients: Physical, social, emotional, and functional well-being
Questionnaire: European Organisation for Research and Treatment of Cancer, EORTC QLQ-BR23)
Time frame: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks
Observation and analysis for measuring the quality of life in patients with breast cancer
1 secondary outcome
Additional questions regarding the "Traditional Chinese Medicine Program for Reinforcing Vital Energy"
Time frame: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks
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 4 Jun 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.
Chung-Hua Hsu, MD. PhD contact
Chung-Hua Hsu, MD. PhD study director
Linsen, Chinese Medicine and Kunming Branch, Taipei City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy in people with Breast Cancer and Neoplasm, Breast, run by Taipei City Hospital 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 3 inclusion and 6 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 4 Jun 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?
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 Yu-Hsuan Tai, MD (+886918130891, daidayangisele@gmail.com, DBB02@tpech.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire: Constitution in Chinese Medicine Questionnaire (time frame: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks). The study lists 3 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 4 Jun 2025.