NCT03797248

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 310 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early-stage Breast Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Chinese herbal medicine	All Chinese herbal products prescribed from TCM physicians in our hospital during patients receiving adjuvant chemotherapy

Timeline

• Start date: 2018-11-12
• Primary completion: 2020-10-24
• Completion: 2020-10-24
• First posted: 2019-01-09
• Last updated: 2019-09-17

Locations

1 site across 1 country: Taiwan