CancerNCT07790692
Efficacy and Safety of a Heated Chinese Herbal Medicine Patch for Chemotherapy-Induced Leukopenia: A Four-Arm Randomized Sham-Controlled Pilot Trial
A study testing The experimental group (heated TCM plaster group), Heat source without TCM plaster group and No heat source with TCM plaster group in people with Cancer and Anemia, run by Hung-Rong Yen at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- What is being tested?
- The experimental group (heated TCM plaster group), Heat source without TCM plaster group and No heat source with TCM plaster group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Jun 2025to 4 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were eligible if they were:
- 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.
- can understand and voluntarily sign the informed consent form t
Who cannot join
- The following conditions disqualify participants from the study:
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taichung armed forces gereral hospital
Taichung, Taiping District, 411228
About this study
Official title: Efficacy and Safety of Heated Chinese Herb Medicine Patch Therapy on Chemotherapy-Induced Aplastic Anemia
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.
Read more
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.
- Being tested
- The experimental group (heated TCM plaster group), Control group (sham heated TCM plaster group), Heat source without TCM plaster group, No heat source with TCM plaster group
- Medical subject headings
- Neoplasms, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Heat source without TCM plaster groupOther
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 groupOther
Only a TCM medicinal cake is applied to the Shenque point, with no heat source or moxibustion box used.
| Study group | Role | What they receive |
|---|---|---|
| Control group (sham heated TCM plaster group) | Sham comparator | No heat source, no TCM plaster group Receives: Other: Control group (sham heated TCM plaster group) |
| Experimental group (Heated TCM plaster group) | Experimental | Heat source + TCM plaster group Receives: Other: The experimental group (heated TCM plaster group) |
| Heat source without TCM plaster group | Placebo comparator | heat source, no TCM plaster group Receives: Other: Heat source without TCM plaster group |
| No heat source with TCM plaster group | Placebo comparator | no heat source, but TCM plaster group Receives: Other: No heat source with TCM plaster group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
Measured: 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"
Measured: Before the intervention (baseline, Day 1)
"FACT-G Quality of Life Questionnaire for Cancer Patients (Version 4)"
The Functional Assessment of Cancer Therapy-General Questionnaire(FACT-G)comprises 27 questions that assess four primary dimensions of QOL: physical (PWB; 7 items), social and family (SFWB; 7 items), emotional (EWB; 6 items), and functional well-being (FWB; 7 items). It uses 5-point Likert-type response categories ranging from 0 = 'not at all' to 4 = 'very much'. The total FACT-G score is the summation of the 4 subscale scores and ranges from 0 to 108. The higher scores in FACT-G mean a better or worse outcome.
Measured: Before the intervention (baseline, Day 1) and after completion of the 12 intervention sessions (2 weeks)
the number of G-CSF
Measured: 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
Measured: the number of blood transfusions used during the 12 intervention sessions period (at the end of this cycle, the cycle is 14 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start25 Jun 2025
- Primary completion8 Jul 2025
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hung-Rong Yen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hung-Rong Yen, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790692
- Sponsor's protocol ID
- CMUH114-REC3-063
- Status last verified
- Nov 2026
- First submitted
- 20 Jun 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Heated Chinese Herb Medicine Patch Therapy on Chemotherapy-Induced Aplastic Anemia
- ClinicalTrials.gov ID
- NCT07790692
- Acronym / sponsor ID
- CMUH114-REC3-063
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hung-Rong YenUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 8 Jul 2025 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group (sham heated TCM plaster group) | Sham comparator | Other: Control group (sham heated TCM plaster group)No heat source, no TCM plaster group |
| Experimental group (Heated TCM plaster group) | Experimental | Other: The experimental group (heated TCM plaster group)Heat source + TCM plaster group |
| Heat source without TCM plaster group | Placebo comparator | Other: Heat source without TCM plaster groupheat source, no TCM plaster group |
| No heat source with TCM plaster group | Placebo comparator | Other: No heat source with TCM plaster groupno heat source, but TCM plaster group |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- can understand and voluntarily sign the informed consent form t
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Experimental group (Heated TCM plaster group) |
| 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. | Other | Control group (sham heated TCM plaster group) |
| Heat source without TCM plaster groupOnly 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.) | Other | Heat source without TCM plaster group |
| No heat source with TCM plaster groupOnly a TCM medicinal cake is applied to the Shenque point, with no heat source or moxibustion box used. | Other | No heat source with TCM plaster group |
Primary outcome
Number of participants with abnormal blood tests results
Time frame: Before the intervention (baseline, Day 1) and within 3 days after completion of the 12 intervention sessions(2 weeks).
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:
4 secondary outcomes
"Traditional Chinese Medicine Constitution Questionnaire"
Time frame: Before the intervention (baseline, Day 1)
"FACT-G Quality of Life Questionnaire for Cancer Patients (Version 4)"
Time frame: Before the intervention (baseline, Day 1) and after completion of the 12 intervention sessions (2 weeks)
the number of G-CSF
Time frame: 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
Time frame: the number of blood transfusions used during the 12 intervention sessions period (at the end of this cycle, the cycle is 14 days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The experimental group (heated TCM plaster group), Heat source without TCM plaster group and No heat source with TCM plaster group in people with Cancer and Anemia, run by Hung-Rong Yen at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with abnormal blood tests results (time frame: Before the intervention (baseline, Day 1) and within 3 days after completion of the 12 intervention sessions(2 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.