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

NCT03797248 | Unknown

• 1 other identifier: 201801559A3
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

Early-stage Breast Cancer

Keywords

traditional Chinese medicine; quality of life; disease-free survival; adjuvant chemotherapy; breast cancer

Outcome Measures

Primary Outcomes (1)

• disease-free survival

  3-year disease-free survival

  3 years

Secondary Outcomes (5)

• QOLs measurement-1

  6 months

• QOLs measurement-2

  6 months

• TCM pattern

  6 months

• meridian energy

  6 months

• Side effects of adjuvant chemotherapy

  6 months

Study Arms (2)

Cohort 1

adjuvant chemotherapy combined with Chinese herbal medicine

Combination Product: Chinese herbal medicine

Cohort 2

adjuvant chemotherapy only

Combination Product: Chinese herbal medicine

Interventions

Chinese herbal medicine COMBINATION_PRODUCT

All Chinese herbal products prescribed from TCM physicians in our hospital during patients receiving adjuvant chemotherapy

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 31847861 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Chien-Ting Liu, MD

  Division of Oncology, Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Yen Tsai, PhD

CONTACT

+886975056534; missuriae@yahoo.com.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Chinese medicine

Study Record Dates

• First Submitted: January 5, 2019
• First Posted: January 9, 2019
• Study Start: November 12, 2018
• Primary Completion: October 24, 2020
• Study Completion: October 24, 2020
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)