Clinical trial NCT06337214: TCM Therapy Program Impact on Breast Cancer Patients' Vital Energy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Neoplasm, Breast
Patient Participation
Mental Health Issue
Keywords: Breast Cancer
Reinforcing Vital Energy
Patients Association
Patients Educatioin
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Questionnaire: Constitution in Chinese Medicine Questionnaire
timeFrame: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks
measure: Questionnaire: Functional Assessment of Cancer Therapy-General Scale, FACT-G)(Version 4)
timeFrame: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks
measure: Questionnaire: European Organisation for Research and Treatment of Cancer, EORTC QLQ-BR23)
timeFrame: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks
Secondary outcomes:
measure: Additional questions regarding the "Traditional Chinese Medicine Program for Reinforcing Vital Energy"
timeFrame: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei City Hospital
Study officials:
affiliation: Linsen, Chinese Medicine and Kunming Branch, Taipei City Hospital
name: Chung-Hua Hsu, MD. PhD
role: STUDY_DIRECTOR
References: