TCM Therapy Program Impact on Breast Cancer Patients' Vital Energy

NCT ID: NCT06337214

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-13
• Study Completion Date: 2025-12-31

Brief 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.

Detailed 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.

Conditions

Breast Cancer; Neoplasm, Breast; Patient Participation; Mental Health Issue

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy

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" , 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. Evaluations will be conducted using pre- and post-tests spaced 4 to 6 weeks apart, during which participants will be administered three questionnaires.

Group Type: EXPERIMENTAL

Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Chung-Hua Hsu

Attending physician of the hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chung-Hua Hsu, MD. PhD

Role: STUDY_DIRECTOR

Linsen, Chinese Medicine and Kunming Branch, Taipei City Hospital

Locations

Taipei City Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yu-Hsuan Tai, MD

Role: CONTACT

daidayangisele@gmail.com, DBB02@tpech.gov.tw

+886918130891

Chung-Hua Hsu, MD. PhD

Role: CONTACT

Facility Contacts

Yu-Hsuan Tai, MD

Role: primary

daidayangisele@gmail.com,dbb02@tpech.gov.tw

+886918130891

Other Identifiers

TCHIRB-11301014-E

Identifier Type: -

Identifier Source: org_study_id