Efficacy and Safety of Heated Chinese Herb Medicine Patch Therapy on Chemotherapy-Induced Aplastic Anemia

NCT07790692 | Completed

• 1 other identifier: CMUH114-REC3-063
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Anemia

Outcome Measures

Primary Outcomes (1)

• Number of participants with abnormal blood tests results

  A complete blood count (CBC) and differential count (DC) will be performed by the hospital's Department of Laboratory Medicine. A 3 mL blood sample will be collected before and after the intervention, for a total of two blood draws. The test items are as follows:

  Before the intervention (baseline, Day 1) and within 3 days after completion of the 12 intervention sessions(2 weeks).

Secondary Outcomes (4)

• "Traditional Chinese Medicine Constitution Questionnaire"

  Before the intervention (baseline, Day 1)

• "FACT-G Quality of Life Questionnaire for Cancer Patients (Version 4)"

  Before the intervention (baseline, Day 1) and after completion of the 12 intervention sessions (2 weeks)

• the number of G-CSF

  the number of G-CSF used during the 12 intervention sessions period (at the end of this cycle, the cycle is 14 days).

• the number of blood transfusions

  the number of blood transfusions used during the 12 intervention sessions period (at the end of this cycle, the cycle is 14 days).

Study Arms (4)

Control group (sham heated TCM plaster group)

SHAM COMPARATOR

No heat source, no TCM plaster group

Other: Control group (sham heated TCM plaster group)

Experimental group (Heated TCM plaster group)

EXPERIMENTAL

Heat source + TCM plaster group

Other: The experimental group (heated TCM plaster group)

Heat source without TCM plaster group

PLACEBO COMPARATOR

heat source, no TCM plaster group

Other: Heat source without TCM plaster group

No heat source with TCM plaster group

PLACEBO COMPARATOR

no heat source, but TCM plaster group

Other: No heat source with TCM plaster group

Interventions

The experimental group (heated TCM plaster group) OTHER

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.

Experimental group (Heated TCM plaster group)

Control group (sham heated TCM plaster group) OTHER

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.

Control group (sham heated TCM plaster group)

Heat source without TCM plaster group OTHER

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.)

Heat source without TCM plaster group

No heat source with TCM plaster group OTHER

Only a TCM medicinal cake is applied to the Shenque point, with no heat source or moxibustion box used.

No heat source with TCM plaster group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were eligible if they were:
• (i) had a diagnosis of stage I-IV cancer. (ii) be aged 20 years or older. (iii)hematological dysfunction: have experienced a WBC count of \<4000/μL or ANC \<1500/μL after starting chemotherapy.
• (iv) can understand and voluntarily sign the informed consent form t

You may not qualify if:

• The following conditions disqualify participants from the study:
• (i) Patients who are unsuitable for moxibustion, including those with wounds at the moxibustion site.
• (ii)Individuals who refuse to sign the informed consent form. (iii) Minors, pregnant women, individuals with mental illnesses, those at risk of harm, or vulnerable groups.
• (iv)Leukemia patients, as the disease itself affects blood cell changes. (v) Those who have used leukopoietic agents or received blood transfusions within the past month.

Sponsors & Collaborators

• Hung-Rong Yen: lead

Study Sites (1)

Taichung armed forces gereral hospital

Taichung, Taiping District, 411228, Taiwan

Location

MeSH Terms

Conditions

Neoplasms; Anemia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: attending physician

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: August 27, 2026
• Study Start: June 25, 2025
• Primary Completion: July 8, 2025
• Study Completion: February 4, 2026
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

TW (1)