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

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.

Study Overview

• Status: Unknown
• Conditions: Early-stage Breast Cancer
• Intervention / Treatment: Combination product: Chinese herbal medicine

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 Type: Observational
• Enrollment (Anticipated): 310

Contacts and Locations

• Study Contact: Name: Ming-Yen Tsai, PhD; Phone Number: +886975056534; Email: missuriae@yahoo.com.tw

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 83301
    • Recruiting
    • Kaohsiung Chang Gung Memorial Hospital
    • Contact: Ming-Yen Tsai; Phone Number: +886975056534 +886975056534; Email: missuriae@yahoo.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; adjuvant chemotherapy combined with Chinese herbal medicine	Combination product: Chinese herbal medicine; All Chinese herbal products prescribed from TCM physicians in our hospital during patients receiving adjuvant chemotherapy
Cohort 2; adjuvant chemotherapy only	Combination product: Chinese herbal medicine; All Chinese herbal products prescribed from TCM physicians in our hospital during patients receiving adjuvant chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease-free survival	3-year disease-free survival	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QOLs measurement-1	Functional Assessment of Cancer Therapy - Breast Cancer(FACT-B)	6 months
QOLs measurement-2	Eastern Cooperative Oncology Group (ECOG)	6 months
TCM pattern	Body Constitution Questionnaire (BCQ)	6 months
meridian energy	Meridian Energy Analysis Device (MEAD)	6 months
Side effects of adjuvant chemotherapy	Common Terminology Criteria for Adverse Events (CTCAE)	6 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Chien-Ting Liu, MD, Division of Oncology, Department of Internal Medicine

Publications and helpful links

General Publications

• Liu 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Anticipated): October 24, 2020
• Study Completion (Anticipated): October 24, 2020

Study Registration Dates

• First Submitted: January 5, 2019
• First Submitted That Met QC Criteria: January 5, 2019
• First Posted (Actual): January 9, 2019

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 15, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: breast cancer; quality of life; traditional Chinese medicine; adjuvant chemotherapy; disease-free survival
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 201801559A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The datasets during and/or analyzed during the current study available from the corresponding author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No