Early-stage Breast CancerNCT03797248
Prospective Cohort Study of Traditional Chinese Medicine for Survival of Patients With Early Breast Cancer
An observational study of Early-stage Breast Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This 2-year trial is intended to be used to study breast cancer patients through forward-looking generation design through collaboration between Chinese and Western medical teams. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Early-stage Breast Cancer
- What is being tested?
- Chinese herbal medicine
- How many people
- 310 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Nov 2018to 24 Oct 2020
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast cancer aged over 20 years with histologically diagnosed stage 1-3 after radical surgery are enrolled from an academic medical center. All participants need to complete the 6-8 cycle of adjuvant chemotherapy, which may last 6 months.
Who may be able to join
- Aged > 20 years old female patients;
- Patients with histologically proven stage 1-3 breast cancer after surgery;
- The duration from the end of radical surgery to the beginning of the trail is less than 1 month;
- ECOG score is 0-2 points;
- Agreed to participate in this study and signed informed consent.
Who cannot join
- Combined with inadequate heart, liver, kidney and hematopoietic function and other serious diseases;
- Pregnant and lactating women;
- Patients with a history of mental illness;
- Patients with distant metastasis and/or expected lifetime less than 3 months;
- Patients undergoing other medicinal herbs outside our hospital.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Ming-Yen Tsai, +886975056534 ext. +886975056534, missuriae@yahoo.com.tw
About this study
Official title: The Clinical Outcome of Adjuvant Chemotherapy in Conjunction With Traditional Chinese Medicine in Breast Cancer Patients -a Observational Cohort Study
This 2-year trial is intended to be used to study breast cancer patients through forward-looking generation design through collaboration between Chinese and Western medical teams. The whole study consists of 2 stages, stage I comprises a cross-sectional study-baseline and stage II is a cohort for outcome evaluation and follow-up study across a 3-year period. To provide an empirical basis for combined TCM treatment in the Breast Cancer Research Team and to publish that as a reference for future TCM and Western medicine in integrative cancer treatment.
Read the detailed description
Breast cancer is a major health issue for women worldwide and has increased exponentially in the last decades. Improved earlier detection combined with adjuvant systemic therapy is responsible for much of the reduction in cause-specific mortality from breast cancer. Chemotherapy after surgery can decrease the risk of recurrence and is often used as routine treatment in clinic. Because of the fact that a considerable number of patients seek for traditional Chinese medicine (TCM) during adjuvant chemotherapy, it is thus need to evaluate the correlation between TCM treatment and prognosis. The investigators design a single center, prospective cohort study began in November 2018 in Kaohsiung, Taiwan. A sample of 104 participants diagnosed with early breast cancer was recruited from Breast Cancer Research Team and are followed up every 3 to 6 months till October 2023. Detailed information of participants includes general information, history of cancer, quality of life, side effects of chemotherapy and safety of treatment, body constitution of TCM and meridian energy analysis is taken face-to-face at baseline.
- Conditions
- Early-stage Breast Cancer
- Being tested
- Chinese herbal medicine
- Keywords
- traditional Chinese medicine, quality of life, disease-free survival, adjuvant chemotherapy, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herbal medicineCombination product
All Chinese herbal products prescribed from TCM physicians in our hospital during patients receiving adjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | adjuvant chemotherapy combined with Chinese herbal medicine Receives: Combination Product: Chinese herbal medicine | |
| Cohort 2 | adjuvant chemotherapy only Receives: Combination Product: Chinese herbal medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
3-year disease-free survival
Measured: 3 years
Secondary outcomes (5)
QOLs measurement-1
Functional Assessment of Cancer Therapy - Breast Cancer(FACT-B)
Measured: 6 months
QOLs measurement-2
Eastern Cooperative Oncology Group (ECOG)
Measured: 6 months
TCM pattern
Body Constitution Questionnaire (BCQ)
Measured: 6 months
meridian energy
Meridian Energy Analysis Device (MEAD)
Measured: 6 months
Side effects of adjuvant chemotherapy
Common Terminology Criteria for Adverse Events (CTCAE)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start12 Nov 2018
- Primary completion24 Oct 2020 (estimated)
- Study completion24 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Early-stage Breast CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-Yen Tsai, Chang Gung Memorial Hospital
- Investigators
- Chien-Ting Liu, MD, Principal investigator, Division of Oncology, Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797248
- Sponsor's protocol ID
- 201801559A3
- Status last verified
- Sep 2019
- First submitted
- 5 Jan 2019
- Last updated
- 17 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets during and/or analyzed during the current study available from the corresponding author on reasonable request.
Publications
Chin CY, Wu SC, Wang HY, Liu CT, Huang YC, Tsai MY. Efficacy of Chinese Herbal Medicine in Managing Hot Flushes in Breast Cancer Patients on Adjuvant Chemotherapy: A Clinical Investigation. Integr Cancer Ther. 2025 Jan-Dec;24:15347354251398843. doi: 10.1177/15347354251398843. Epub 2025 Nov 29.
PubMed 41317109Liu CT, Chen YH, Huang YC, Chen SY, Tsai MY. Chemotherapy in conjunction with traditional Chinese medicine for survival of patients with early female breast cancer: protocol for a non-randomized, single center prospective cohort study. Trials. 2019 Dec 17;20(1):741. doi: 10.1186/s13063-019-3848-8.
PubMed 31847861
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Outcome of Adjuvant Chemotherapy in Conjunction With Traditional Chinese Medicine in Breast Cancer Patients -a Observational Cohort Study
- ClinicalTrials.gov ID
- NCT03797248
- Acronym / sponsor ID
- 201801559A3
- Conditions
- Early-stage Breast Cancer
- Keywords
- traditional Chinese medicine, quality of life, disease-free survival, adjuvant chemotherapy, breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 24 Oct 2020 (estimated)
- Study completion
- 24 Oct 2020 (estimated)
- First posted
- 9 Jan 2019 (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 2-year trial is intended to be used to study breast cancer patients through forward-looking generation design through collaboration between Chinese and Western medical teams. The whole study consists of 2 stages, stage I comprises a cross-sectional study-baseline and stage II is a cohort for outcome evaluation and follow-up study across a 3-year period. To provide an empirical basis for combined TCM treatment in the Breast Cancer Research Team and to publish that as a reference for future TCM and Western medicine in integrative cancer treatment.
Detailed description
Breast cancer is a major health issue for women worldwide and has increased exponentially in the last decades. Improved earlier detection combined with adjuvant systemic therapy is responsible for much of the reduction in cause-specific mortality from breast cancer. Chemotherapy after surgery can decrease the risk of recurrence and is often used as routine treatment in clinic. Because of the fact that a considerable number of patients seek for traditional Chinese medicine (TCM) during adjuvant chemotherapy, it is thus need to evaluate the correlation between TCM treatment and prognosis. The investigators design a single center, prospective cohort study began in November 2018 in Kaohsiung, Taiwan. A sample of 104 participants diagnosed with early breast cancer was recruited from Breast Cancer Research Team and are followed up every 3 to 6 months till October 2023. Detailed information of participants includes general information, history of cancer, quality of life, side effects of chemotherapy and safety of treatment, body constitution of TCM and meridian energy analysis is taken face-to-face at baseline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Combination Product: Chinese herbal medicineadjuvant chemotherapy combined with Chinese herbal medicine |
| Cohort 2 | – | Combination Product: Chinese herbal medicineadjuvant chemotherapy only |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast cancer aged over 20 years with histologically diagnosed stage 1-3 after radical surgery are enrolled from an academic medical center. All participants need to complete the 6-8 cycle of adjuvant chemotherapy, which may last 6 months.
Key inclusion criteria (5 listed)
- Aged > 20 years old female patients;
- Patients with histologically proven stage 1-3 breast cancer after surgery;
- The duration from the end of radical surgery to the beginning of the trail is less than 1 month;
- ECOG score is 0-2 points;
- Agreed to participate in this study and signed informed consent.
Key exclusion criteria (5 listed)
- Combined with inadequate heart, liver, kidney and hematopoietic function and other serious diseases;
- Pregnant and lactating women;
- Patients with a history of mental illness;
- Patients with distant metastasis and/or expected lifetime less than 3 months;
- Patients undergoing other medicinal herbs outside our hospital.
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 |
|---|---|---|
| Chinese herbal medicineAll Chinese herbal products prescribed from TCM physicians in our hospital during patients receiving adjuvant chemotherapy | Combination product | Cohort 1, Cohort 2 |
Primary outcome
disease-free survival
Time frame: 3 years
3-year disease-free survival
5 secondary outcomes
QOLs measurement-1
Time frame: 6 months
QOLs measurement-2
Time frame: 6 months
TCM pattern
Time frame: 6 months
meridian energy
Time frame: 6 months
Side effects of adjuvant chemotherapy
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Derived from this study: PubMed 41317109Chin CY, Wu SC, Wang HY, Liu CT, Huang YC, Tsai MY. Efficacy of Chinese Herbal Medicine in Managing Hot Flushes in Breast Cancer Patients on Adjuvant Chemotherapy: A Clinical Investigation. Integr Cancer Ther. 2025 Jan-Dec;24:15347354251398843. doi: 10.1177/15347354251398843. Epub 2025 Nov 29.
- Derived from this study: PubMed 31847861Liu CT, Chen YH, Huang YC, Chen SY, Tsai MY. Chemotherapy in conjunction with traditional Chinese medicine for survival of patients with early female breast cancer: protocol for a non-randomized, single center prospective cohort study. Trials. 2019 Dec 17;20(1):741. doi: 10.1186/s13063-019-3848-8.
- Individual participant dataSharing planned: No. The datasets during and/or analyzed during the current study available from the corresponding author on reasonable request.
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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.
Chien-Ting Liu, MD principal investigator
Division of Oncology, Department of Internal Medicine
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 Early-stage Breast Cancer, run by Chang Gung Memorial 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming-Yen Tsai, PhD (+886975056534, missuriae@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03797248, which also lists 2 linked publications.
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 17 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.