TCM Therapy Program Impact on Breast Cancer Patients' Vital Energy

May 31, 2025 updated by: Chung-Hua Hsu, Taipei City Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Chung-Hua Hsu, MD. PhD

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire: Constitution in Chinese Medicine Questionnaire
Time Frame: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks
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
Questionnaire: Functional Assessment of Cancer Therapy-General Scale, FACT-G)(Version 4)
Time Frame: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks
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
Questionnaire: European Organisation for Research and Treatment of Cancer, EORTC QLQ-BR23)
Time Frame: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional questions regarding the "Traditional Chinese Medicine Program for Reinforcing Vital Energy"
Time Frame: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei City Hospital

Investigators

  • Study Director: Chung-Hua Hsu, MD. PhD, Linsen, Chinese Medicine and Kunming Branch, Taipei City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 23, 2024

First Submitted That Met QC Criteria

March 23, 2024

First Posted (Actual)

March 29, 2024

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

May 31, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCHIRB-11301014-E

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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