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NCT Number: NCT06337214

TCM Therapy Program Impact on Breast Cancer Patients' Vital Energy

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chung-Hua Hsu, MD. PhD

CONTACT

Yu-Hsuan Tai, MD

CONTACT

[email protected], [email protected]

+886918130891

Sponsors and collaborators

Lead sponsor

Taipei City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 29, 2024
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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