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RecruitingNCT06337214Updated Jun 4, 2025

TCM Therapy Program Impact on Breast Cancer Patients' Vital Energy

An interventional study of Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy in Breast Cancer, Neoplasm, Breast and Patient Participation, sponsored by Taipei City Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-06-04.

Sponsored by Taipei City Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Breast Cancer
  • Reinforcing Vital Energy
  • Patients Association
  • Patients Educatioin
03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 80 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Taipei City Hospital is the lead sponsor of 57 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • 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

Interventions

  • BehavioralTraditional 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.

06

What researchers measure

Primary outcomes

  1. Questionnaire: Constitution in Chinese Medicine Questionnaire

    Observation and analysis Traditional Chinese Medicine Constitutions in breast cancer undergoing treatment

    Time frame: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks

  2. Questionnaire: Functional Assessment of Cancer Therapy-General Scale, FACT-G)(Version 4)

    Observation and analysis to measure four domains of QoL in cancer patients: Physical, social, emotional, and functional well-being

    Time frame: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks

  3. Questionnaire: European Organisation for Research and Treatment of Cancer, EORTC QLQ-BR23)

    Observation and analysis for measuring the quality of life in patients with breast cancer

    Time frame: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks

Secondary outcomes

  1. Additional questions regarding the "Traditional Chinese Medicine Program for Reinforcing Vital Energy"

    Understanding and Course satisfaction and Confidence in cancer recovery

    Time frame: Pre-test → Participation in "Traditional Chinese Medicine Program for Reinforcing Vital Energy" or not → Post-test After 4 ~6 weeks

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2024 (actual). Primary completion is estimated for Dec 2025, 21 months after the start.

Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 21 months is below that.

Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 23, 2024
First posted
Mar 29, 2024
StartActual
Mar 13, 2024
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
Jun 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06337214
Lead sponsor
Taipei City Hospital
Responsible party
Chung-Hua Hsu (Attending physician of the hospital, Taipei City Hospital) — Principal investigator
First posted
Mar 29, 2024
Start date
Mar 13, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jun 4, 2025

Study contacts

Yu-Hsuan Tai, MD
Contact
daidayangisele@gmail.com, DBB02@tpech.gov.tw
+886918130891
Chung-Hua Hsu, MD. PhD
Contact
Chung-Hua Hsu, MD. PhD
study director · Linsen, Chinese Medicine and Kunming Branch, Taipei City Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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