Clinical Observational Studies:Integrative TCM and Western Medicine for Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chemotherapy drug, Integrative Treatment (Chemotherapy + TCM).
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Observational Studies: Breast Cancer Treatment by Traditional Chinese and Western Medicine
Overview
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.
A. 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.
B. Patients will continue their follow-up visits at the oncology and TCM clinics, receiving both conventional Western medicine treatments and TCM treatments.
C. 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.
D. 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.
E. 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.
Interventions
- Drug Chemotherapy drug
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. - Other 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.
Primary outcome measures
- 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.]
- 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.]
- 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.]
- 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.]
- EQ-5D (EuroQol Five Dimensions Questionnaire) [Time frame: On the day of each chemotherapy cycle (Day 1 of each cycle)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Taiwan · 1 center
- Buddhist Taipei Tzu Chi General Hospital — New Taipei City
Identifiers
NCT: NCT07096180 · 12-XD-090