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

Last updated: September 15, 2019
Sponsor: Chang Gung Memorial Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03797248
201801559A3
  • Ages > 20
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 lessthan 1 month;

  • ECOG score is 0-2 points;

  • Agreed to participate in this study and signed informed consent.

Exclusion

Exclusion Criteria:

  • Combined with inadequate heart, liver, kidney and hematopoietic function and otherserious 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 Design

Total Participants: 310
Study Start date:
November 12, 2018
Estimated Completion Date:
October 24, 2020

Study 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.

Connect with a study center

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung, 83301
    Taiwan

    Active - Recruiting

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