Breast CancerNCT07096180
Clinical Observational Studies:Integrative TCM and Western Medicine for Breast Cancer
An observational study of Breast Cancer, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial summary
The aim of this study is to investigate the intervention of traditional Chinese medicine (TCM) in managing the side effects experienced by breast cancer patients undergoing conventional Western medical treatments, such as blood cell decline, nausea, vomiting, gastrointestinal discomfort, and overall quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Chemotherapy drug and Integrative Treatment (Chemotherapy + TCM)
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female breast cancer patients diagnosed by oncologists or surgeons at Taipei Tzu Chi Hospital, who are receiving or have received chemotherapy. Participants will be grouped based on their willingness to receive Traditional Chinese Medicine (TCM) in addition to standard Western medical treatment. All participants are aged 20 years or older and able to complete questionnaire-based assessments.
Who may be able to join
- A. Aged 18 years or above.
- B. Female patients diagnosed with primary breast cancer and receiving Western medical treatment. The included breast cancer diagnosis codes based on ICD-9 are 174 to 179.
Who cannot join
- A. Patients with a prior diagnosis of other malignant tumors before being diagnosed with primary breast cancer.
- B. Patients with primary breast cancer who have not received Western medical treatment, meaning they have not undergone surgical resection, radiation therapy, chemotherapy, or targeted therapy..
- C. After taking Chinese medicine, those who have uncomfortable symptoms or whose behavior affects Western medicine treatment should withdraw from the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Buddhist Taipei Tzu Chi General Hospital
New Taipei City
H. C. Wu, MD., +886266289009, xuang@tzuchi.com.tw
About this study
Official title: Clinical Observational Studies: Breast Cancer Treatment by Traditional Chinese and Western Medicine
The aim of this study is to investigate the intervention of traditional Chinese medicine (TCM) in managing the side effects experienced by breast cancer patients undergoing conventional Western medical treatments, such as blood cell decline, nausea, vomiting, gastrointestinal discomfort, and overall quality of life. The study aims to establish a long-term clinical enrollment criteria and process for TCM adjuvant therapy in breast cancer. The research design will utilize a prospective cohort study and real-world cross-sectional observational research method to obtain clinical data and survival status of the patients.
Read the detailed description
Two-group parallel experimental design. One group received conventional Western medicine treatment, while the other group received combined treatment with both traditional Chinese and Western medicine treatment.
- Patients who opt for integrated traditional Chinese medicine (TCM) treatment will be referred to the TCM outpatient department, where a TCM practitioner will prescribe TCM prescriptions, followed by the initial clinical effectiveness assessment.
- Patients will continue their follow-up visits at the oncology and TCM clinics, receiving both conventional Western medicine treatments and TCM treatments.
- Both the Western medicine treatments and TCM treatments received by the patients are covered by health insurance, and patients do not need to pay anyadditional fees.
- Both the "Conventional Western Medicine Treatment Group" and the "Integrated Western and Chinese Medicine Treatment Group" will undergo another clinical effectiveness assessment (blood tests) before the next cancer treatment.
- A questionnaire will be administered before starting chemotherapy and before each research visit for treatment evaluation. A final evaluation will be conducted within four weeks after the last radiation or chemotherapy session. The questionnaire includes the EOG, BFI-T, FACT-B,EORTC-QLQ-C30, EORTC-QLQ-BR23, WHOQOL-BREF, and BCQ.
- Conditions
- Breast Cancer
- Being tested
- Chemotherapy drug, Integrative Treatment (Chemotherapy + TCM)
- Keywords
- Traditional Chinese medicine, Adjunctive therapy, Side-Effect, 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.
Chemotherapy drugDrug
Participants in the standard care group receive conventional chemotherapy for breast cancer according to clinical guidelines. Treatment includes 8 cycles of chemotherapy administered every 3 weeks. No Traditional Chinese Medicine (TCM) is provided in this group.
Integrative Treatment (Chemotherapy + TCM)Other
Participants in the integrative care group receive conventional chemotherapy combined with Traditional Chinese Medicine (TCM) treatment. Herbal formulas are prescribed by licensed TCM physicians based on syndrome differentiation and are aimed at strengthening vital qi and harmonizing stomach function. Treatment is conducted under Taiwan's National Health Insurance coverage.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Western Medicine Treatment Group | Patients receive standard Western medical care, including chemotherapy, according to clinical guidelines. No Traditional Chinese Medicine (TCM) is involved. Clinical assessments and questionnaires are administered throughout the treatment course. Receives: Drug: Chemotherapy drug | |
| Integrative Treatment Group (Western Medicine + TCM) | Patients receive both standard Western medical care (e.g., chemotherapy) and Traditional Chinese Medicine (TCM) treatments. TCM is prescribed based on syndrome differentiation and focuses on supporting healthy qi and mitigating side effects. Clinical assessments and questionnaires are administered throughout the treatment course. Receives: Other: Integrative Treatment (Chemotherapy + TCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACT-B (Functional Assessment of Cancer Therapy - Breast)
The FACT-B is a validated questionnaire used to assess quality of life in breast cancer patients. It includes domains such as physical well-being, social/family well-being, emotional well-being, functional well-being, and breast cancer-specific concerns.
Measured: A standard 8-cycle chemotherapy regimen will be administered every 21 days. Patient-reported outcome questionnaires will be collected at baseline (pre-Cycle 1), every other cycle , and 3 weeks after the final cycle.
EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30)
The EORTC QLQ-C30 is a validated, cancer-specific, patient-reported quality of life questionnaire. It consists of 30 items covering five functional domains (physical, role, emotional, cognitive, and social), three symptom domains (fatigue, pain, nausea/vomiting), a global health status/QoL scale, and several single items (e.g., dyspnea, insomnia). It is widely used in cancer clinical trials for measuring changes in quality of life during treatment.
Measured: A standard 8-cycle chemotherapy regimen will be administered every 21 days. Patient-reported outcome questionnaires will be collected at baseline (pre-Cycle 1), every other cycle , and 3 weeks after the final cycle.
WHOQOL-BREF (World Health Organization Quality of Life - BREF)
The WHOQOL-BREF is a 26-item questionnaire developed by the World Health Organization to assess an individual's perception of their quality of life in four domains: physical health, psychological health, social relationships, and environment. It is widely used for evaluating general quality of life in clinical populations.
Measured: A standard 8-cycle chemotherapy regimen will be administered every 21 days. Patient-reported outcome questionnaires will be collected at baseline (pre-Cycle 1), every other cycle , and 3 weeks after the final cycle.
BCQ (Body Constitution Questionnaire)
The BCQ is a self-reported questionnaire developed based on Traditional Chinese Medicine (TCM) theory. It evaluates individual body constitution types, including Yang deficiency, Yin deficiency, and Stasis constitution. The tool is useful in assessing patients' constitutional status and monitoring changes during treatment, especially in integrative TCM studies.
Measured: A standard 8-cycle chemotherapy regimen will be administered every 21 days. Patient-reported outcome questionnaires will be collected at baseline (pre-Cycle 1), every other cycle , and 3 weeks after the final cycle.
EQ-5D (EuroQol Five Dimensions Questionnaire)
The EQ-5D is a standardized instrument developed by the EuroQol Group to measure health-related quality of life. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It also includes a visual analog scale (VAS) to rate overall health. It is widely used in health economic evaluations and patient-reported outcome assessments.
Measured: On the day of each chemotherapy cycle (Day 1 of each cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsien-Chang Wu, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Investigators
- Hsien-Chang Wu, Principal investigator, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096180
- Sponsor's protocol ID
- 12-XD-090
- Status last verified
- Jul 2025
- First submitted
- 3 Jun 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (IPD) will not be shared publicly. Data may be available upon reasonable request to the principal investigator after publication of the main study results, subject to approval of a data sharing agreement to protect participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observational Studies: Breast Cancer Treatment by Traditional Chinese and Western Medicine
- ClinicalTrials.gov ID
- NCT07096180
- Acronym / sponsor ID
- 12-XD-090
- Conditions
- Breast Cancer
- Keywords
- Traditional Chinese medicine, Adjunctive therapy, Side-Effect, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Jul 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.
The aim of this study is to investigate the intervention of traditional Chinese medicine (TCM) in managing the side effects experienced by breast cancer patients undergoing conventional Western medical treatments, such as blood cell decline, nausea, vomiting, gastrointestinal discomfort, and overall quality of life. The study aims to establish a long-term clinical enrollment criteria and process for TCM adjuvant therapy in breast cancer. The research design will utilize a prospective cohort study and real-world cross-sectional observational research method to obtain clinical data and survival status of the patients.
Detailed description
Two-group parallel experimental design. One group received conventional Western medicine treatment, while the other group received combined treatment with both traditional Chinese and Western medicine treatment.
- Patients who opt for integrated traditional Chinese medicine (TCM) treatment will be referred to the TCM outpatient department, where a TCM practitioner will prescribe TCM prescriptions, followed by the initial clinical effectiveness assessment.
- Patients will continue their follow-up visits at the oncology and TCM clinics, receiving both conventional Western medicine treatments and TCM treatments.
- Both the Western medicine treatments and TCM treatments received by the patients are covered by health insurance, and patients do not need to pay anyadditional fees.
- Both the "Conventional Western Medicine Treatment Group" and the "Integrated Western and Chinese Medicine Treatment Group" will undergo another clinical effectiveness assessment (blood tests) before the next cancer treatment.
- A questionnaire will be administered before starting chemotherapy and before each research visit for treatment evaluation. A final evaluation will be conducted within four weeks after the last radiation or chemotherapy session. The questionnaire includes the EOG, BFI-T, FACT-B,EORTC-QLQ-C30, EORTC-QLQ-BR23, WHOQOL-BREF, and BCQ.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Western Medicine Treatment Group | – | Drug: Chemotherapy drugPatients receive standard Western medical care, including chemotherapy, according to clinical guidelines. No Traditional Chinese Medicine (TCM) is involved. Clinical assessments and questionnaires are administered throughout the treatment course. |
| Integrative Treatment Group (Western Medicine + TCM) | – | Other: Integrative Treatment (Chemotherapy + TCM)Patients receive both standard Western medical care (e.g., chemotherapy) and Traditional Chinese Medicine (TCM) treatments. TCM is prescribed based on syndrome differentiation and focuses on supporting healthy qi and mitigating side effects. Clinical assessments and questionnaires are administered throughout the treatment course. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female breast cancer patients diagnosed by oncologists or surgeons at Taipei Tzu Chi Hospital, who are receiving or have received chemotherapy. Participants will be grouped based on their willingness to receive Traditional Chinese Medicine (TCM) in addition to standard Western medical treatment. All participants are aged 20 years or older and able to complete questionnaire-based assessments.
Key inclusion criteria (2 listed)
- A. Aged 18 years or above.
- B. Female patients diagnosed with primary breast cancer and receiving Western medical treatment. The included breast cancer diagnosis codes based on ICD-9 are 174 to 179.
Key exclusion criteria (3 listed)
- A. Patients with a prior diagnosis of other malignant tumors before being diagnosed with primary breast cancer.
- B. Patients with primary breast cancer who have not received Western medical treatment, meaning they have not undergone surgical resection, radiation therapy, chemotherapy, or targeted therapy..
- C. After taking Chinese medicine, those who have uncomfortable symptoms or whose behavior affects Western medicine treatment should withdraw from the trial.
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 |
|---|---|---|
| Chemotherapy drugParticipants in the standard care group receive conventional chemotherapy for breast cancer according to clinical guidelines. Treatment includes 8 cycles of chemotherapy administered every 3 weeks. No Traditional Chinese Medicine (TCM) is provided in this group. | Drug | Conventional Western Medicine Treatment Group |
| Integrative Treatment (Chemotherapy + TCM)Participants in the integrative care group receive conventional chemotherapy combined with Traditional Chinese Medicine (TCM) treatment. Herbal formulas are prescribed by licensed TCM physicians based on syndrome differentiation and are aimed at strengthening vital qi and harmonizing stomach function. Treatment is conducted under Taiwan's National Health Insurance coverage. | Other | Integrative Treatment Group (Western Medicine + TCM) |
Primary outcome
FACT-B (Functional Assessment of Cancer Therapy - Breast)
Time frame: A standard 8-cycle chemotherapy regimen will be administered every 21 days. Patient-reported outcome questionnaires will be collected at baseline (pre-Cycle 1), every other cycle , and 3 weeks after the final cycle.
The FACT-B is a validated questionnaire used to assess quality of life in breast cancer patients. It includes domains such as physical well-being, social/family well-being, emotional well-being, functional well-being, and breast cancer-specific concerns.
EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30)
Time frame: A standard 8-cycle chemotherapy regimen will be administered every 21 days. Patient-reported outcome questionnaires will be collected at baseline (pre-Cycle 1), every other cycle , and 3 weeks after the final cycle.
The EORTC QLQ-C30 is a validated, cancer-specific, patient-reported quality of life questionnaire. It consists of 30 items covering five functional domains (physical, role, emotional, cognitive, and social), three symptom domains (fatigue, pain, nausea/vomiting), a global health status/QoL scale, and several single items (e.g., dyspnea, insomnia). It is widely used in cancer clinical trials for measuring changes in quality of life during treatment.
WHOQOL-BREF (World Health Organization Quality of Life - BREF)
Time frame: A standard 8-cycle chemotherapy regimen will be administered every 21 days. Patient-reported outcome questionnaires will be collected at baseline (pre-Cycle 1), every other cycle , and 3 weeks after the final cycle.
The WHOQOL-BREF is a 26-item questionnaire developed by the World Health Organization to assess an individual's perception of their quality of life in four domains: physical health, psychological health, social relationships, and environment. It is widely used for evaluating general quality of life in clinical populations.
BCQ (Body Constitution Questionnaire)
Time frame: A standard 8-cycle chemotherapy regimen will be administered every 21 days. Patient-reported outcome questionnaires will be collected at baseline (pre-Cycle 1), every other cycle , and 3 weeks after the final cycle.
The BCQ is a self-reported questionnaire developed based on Traditional Chinese Medicine (TCM) theory. It evaluates individual body constitution types, including Yang deficiency, Yin deficiency, and Stasis constitution. The tool is useful in assessing patients' constitutional status and monitoring changes during treatment, especially in integrative TCM studies.
EQ-5D (EuroQol Five Dimensions Questionnaire)
Time frame: On the day of each chemotherapy cycle (Day 1 of each cycle)
The EQ-5D is a standardized instrument developed by the EuroQol Group to measure health-related quality of life. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It also includes a visual analog scale (VAS) to rate overall health. It is widely used in health economic evaluations and patient-reported outcome assessments.
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 31 Jul 2025.
- Individual participant dataSharing planned: No. De-identified individual participant data (IPD) will not be shared publicly. Data may be available upon reasonable request to the principal investigator after publication of the main study results, subject to approval of a data sharing agreement to protect participant privacy.
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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.
Hsien-Chang Wu principal investigator
Taichung Tzu Chi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation 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 2 inclusion and 3 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 31 Jul 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 Hsien-Chang Wu (0266289779, xuang@tzuchi.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACT-B (Functional Assessment of Cancer Therapy - Breast) (time frame: A standard 8-cycle chemotherapy regimen will be administered every 21 days. Patient-reported outcome questionnaires will be collected at baseline (pre-Cycle 1), every other cycle , and 3 weeks after the final cycle.). The study lists 5 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 31 Jul 2025.