Prospective Cohort Study of Traditional Chinese Medicine for Survival of Patients With Early Breast Cancer

Early-stage Breast Cancer Clinical Trial

Official title:

The Clinical Outcome of Adjuvant Chemotherapy in Conjunction With Traditional Chinese Medicine in Breast Cancer Patients -a Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03797248
• Other study ID #: 201801559A3
• Status: Recruiting
• Start date: November 12, 2018
• Est. completion date: October 24, 2020

Study information

• Verified date: September 2019
• Source: Chang Gung Memorial Hospital
• Contact: Ming-Yen Tsai, PhD
• Phone: +886975056534
• Email: missuriae[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: October 24, 2020
• Est. primary completion date: October 24, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Early-stage Breast Cancer

Intervention

Combination Product:
• Chinese herbal medicine
All Chinese herbal products prescribed from TCM physicians in our hospital during patients receiving adjuvant chemotherapy

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival	3-year disease-free survival	3 years
Secondary	QOLs measurement-1	Functional Assessment of Cancer Therapy - Breast Cancer(FACT-B)	6 months
Secondary	QOLs measurement-2	Eastern Cooperative Oncology Group (ECOG)	6 months
Secondary	TCM pattern	Body Constitution Questionnaire (BCQ)	6 months
Secondary	meridian energy	Meridian Energy Analysis Device (MEAD)	6 months
Secondary	Side effects of adjuvant chemotherapy	Common Terminology Criteria for Adverse Events (CTCAE)	6 months