Clinical trial NCT03797248: Prospective Cohort Study of Traditional Chinese Medicine for Survival of Patients With Early Breast Cancer
Official title: The Clinical Outcome of Adjuvant Chemotherapy in Conjunction With Traditional Chinese Medicine in Breast Cancer Patients -a Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early-stage Breast Cancer
Keywords: traditional Chinese medicine
quality of life
disease-free survival
adjuvant chemotherapy
breast cancer
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 310
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: disease-free survival
timeFrame: 3 years
Secondary outcomes:
measure: QOLs measurement-1
timeFrame: 6 months
measure: QOLs measurement-2
timeFrame: 6 months
measure: TCM pattern
timeFrame: 6 months
measure: meridian energy
timeFrame: 6 months
measure: Side effects of adjuvant chemotherapy
timeFrame: 6 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Division of Oncology, Department of Internal Medicine
name: Chien-Ting Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.