Clinical Observational Studies:Integrative TCM and Western Medicine for Breast Cancer
1 other identifier
observational
200
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2024
CompletedFirst Submitted
Initial submission to the registry
June 3, 2025
CompletedFirst Posted
Study publicly available on registry
July 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
July 31, 2025
July 1, 2025
3 years
June 3, 2025
July 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
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.
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.
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.
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.
On the day of each chemotherapy cycle (Day 1 of each cycle)
Study Arms (2)
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.
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.
Interventions
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.
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Buddhist Taipei Tzu Chi General Hospital
New Taipei City, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hsien-Chang Wu
Taichung Tzu Chi Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Department of Traditional Chinese Medicine
Study Record Dates
First Submitted
June 3, 2025
First Posted
July 31, 2025
Study Start
January 1, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
July 31, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share
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.