TCM Therapy Program Impact on Breast Cancer Patients' Vital Energy

Breast Cancer Clinical Trial

Official title:

A Holistic Medical Approach - The Effect of "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" on Breast Cancer Patients Undergoing Cancer Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06337214
• Other study ID #: TCHIRB-11301014-E
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: April 2024
• Source: Taipei City Hospital
• Contact: Yu-Hsuan Tai, MD
• Phone: +886918130891
• Email: daidayangisele[@]gmail.com, DBB02[@]tpech.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to evaluate the impact of the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" on patients with breast cancer who are currently undergoing conventional Western medical treatments in Taiwan. The main questions it aims to answer are: Can the "Traditional Chinese Medicine Therapy Program" alleviate symptoms experienced by breast cancer patients? Does the program improve the quality of life for breast cancer patients receiving Western medical treatments? How does the program contribute to the management of side effects associated with Western oncological therapies? Participants will: Engage in the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" provided by the Taiwan Compassionate Cancer Care Association. Receive supportive and educational services, including auxiliary Chinese medicine treatment courses, lifestyle and health education, and psychological counseling. This study seeks to integrate the concept of holistic healthcare, emphasizing coordinated care that encompasses physical, mental, and social aspects, into the treatment of breast cancer.

Description:

This study aims to evaluate whether the participation in Traditional Chinese Medicine (TCM) supportive therapy courses, specifically the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" combined with the use of the herbal formulation at Taipei City Hospital, can enhance the quality of life of breast cancer patients undergoing treatment, increase their understanding and satisfaction with TCM adjunctive treatments, and bolster their confidence in cancer recovery. This study adopts a holistic healthcare approach, integrating the Traditional Chinese Medicine (TCM) formulation Kuan-Sin-Yin from Taipei City Hospital with the "TCM Therapy Program for Reinforcing Vital Energy" course offered by a cancer patient support organization, to research its effects on breast cancer patients undergoing conventional medical treatment. International standard questionnaires and other inquiries are utilized to evaluate the impact on patients' physical, emotional, spiritual, and social well-being.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Individuals aged 18 years and above and below 85 years, willing to voluntarily participate in the study.
• Diagnosed with malignant breast tumors, ICD-10: C50, by conventional medicine.
• Patients currently undergoing cancer treatment, including chemotherapy, radiotherapy, or targeted therapy.

Exclusion Criteria:

• Diagnosed solely with carcinoma in situ or benign tumors, including fibrocystic breast conditions, by conventional medicine.
• Patients regularly receiving Astragalus polysaccharide injections.
• Patients with a history of allergies to Traditional Chinese Medicine.
• Pregnant or breastfeeding women.
• Individuals with a drug addiction habit, including both narcotic and non-narcotic drugs.
• Any other situation where the participant is unable to cooperate (e.g., due to any factor that prevents participation, deemed unsuitable for participation by study staff, unwillingness to sign the consent form).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Mental Health Issue
• Neoplasm, Breast
• Patient Participation

Intervention

Behavioral:
• Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy
Comparing cancer patients who have participated in the program with those who have not, this study will examine differences in two types of quality of life questionnaires and constitution between the two groups.

Locations

Country	Name	City	State
Taiwan	Taipei City Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire: Constitution in Chinese Medicine Questionnaire	Observation and analysis Traditional Chinese Medicine Constitutions in breast cancer undergoing treatment	Pre-test ? Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not ? Post-test After 4 ~6 weeks
Primary	Questionnaire: Functional Assessment of Cancer Therapy-General Scale, FACT-G)(Version 4)	Observation and analysis to measure four domains of QoL in cancer patients: Physical, social, emotional, and functional well-being	Pre-test ? Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not ? Post-test After 4 ~6 weeks
Primary	Questionnaire: European Organisation for Research and Treatment of Cancer, EORTC QLQ-BR23)	Observation and analysis for measuring the quality of life in patients with breast cancer	Pre-test ? Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not ? Post-test After 4 ~6 weeks
Secondary	Additional questions regarding the "Traditional Chinese Medicine Program for Reinforcing Vital Energy"	Understanding and Course satisfaction and Confidence in cancer recovery	Pre-test ? Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not ? Post-test After 4 ~6 weeks