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Efficacy and Safety of Heated Chinese Herb Medicine Patch Therapy on Chemotherapy-Induced Aplastic Anemia
Sponsor: Hung-Rong Yen
Summary
The objective of this clinical trial is to establish a treatment for chemotherapy-induced pancytopenia symptoms using heated traditional Chinese medicine (TCM) plasters through a randomized, single-blind clinical trial. The primary question it aims to answer is whether heated TCM plasters improve chemotherapy-induced pancytopenia symptoms, maintain or increase white blood cells, platelets, and red blood cells, reduce the use of G-CSF and blood transfusions, and enhance cancer patients' quality of life. It also aims to assess if there are any adverse patient reactions to this treatment. The researchers will compare heated TCM plasters with placebo heated/plaster, placebo TCM plasters, and placebo heated TCM plasters to determine whether the treatment improves chemotherapy-induced pancytopenia symptoms. Participants will apply the plaster for 1 hour, once daily, 6 days a week for 2 consecutive weeks, totaling 12 applications. Full blood tests (Complete Blood Count, CBC) and white blood cell differential count (DC) will be performed before and after the treatment, and participants will complete the FACT-G cancer treatment-related quality of life scale.
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-06-25
Completion Date
2026-02-04
Last Updated
2026-08-27
Healthy Volunteers
No
Interventions
The experimental group (heated TCM plaster group)
Each time, 5g of the medicinal powder is combined with 7g of tap water and applied to gauze to form a medicinal cake. The researcher then places it on the Shenque point (International acupuncture point code: RN8). Additionally, a 3g moxa column with a 80:1 moxa wool ratio is ignited and placed in a moxibustion box to generate heat, which is layered over the medicinal cake for 1 hour. The treatment is applied once a day, 6 days a week, for 2 consecutive weeks, totaling 12 sessions.
Control group (sham heated TCM plaster group)
The same acupuncture points and frequency are used, but instead of the medicinal cake, 5g of flour colored with caramel dye is applied. An unlit moxa column is placed in a moxibustion box to serve as a placebo heat source.
Heat source without TCM plaster group
Only 3g of moxa wool (80:1 ratio) is ignited and placed in a moxibustion box to generate heat. The researcher directly applies it to the Shenque point for 1 hour, once a day, 6 days a week for 2 consecutive weeks, totaling 12 sessions. (If the participant feels it's too hot, they can either move the moxa wool around the Shenque point themselves or ask the researcher to do so to avoid burns.)
No heat source with TCM plaster group
Only a TCM medicinal cake is applied to the Shenque point, with no heat source or moxibustion box used.
Locations (1)
Taichung armed forces gereral hospital
Taichung, Taiping District, Taiwan