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Clinical Trials/NCT06337214
NCT06337214
Recruiting
Not Applicable

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

Taipei City Hospital1 site in 1 country80 target enrollmentMarch 13, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Taipei City Hospital
Enrollment
80
Locations
1
Primary Endpoint
Questionnaire: Constitution in Chinese Medicine Questionnaire
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 13, 2024
End Date
December 31, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chung-Hua Hsu

Attending physician of the hospital

Taipei City Hospital

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).

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

  • Additional questions regarding the "Traditional Chinese Medicine Program for Reinforcing Vital Energy"(Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks)

Study Sites (1)

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