Cancer, Chemotherapy-induced Leukopenia, Chinese Herb Medicine-moxibustionNCT06262542
Efficacy and Safety of Chinese Herb Medicine-Moxibustion Therapy on Chemotherapy-Induced Leukopenia
A study testing moxibustion and Chinese herbal medicine group in people with Cancer, Chemotherapy-induced Leukopenia, Chinese Herb Medicine-moxibustion, run by Taichung Armed Forces General Hospital at 1 site in Taiwan.
Trial summary
Cancer is the second leading cause of death globally, with an estimated 9.6 million deaths in 2018, accounting for one-sixth of total deaths. The economic burden of cancer continues to rise globally, causing significant physiological, psychological, and economic pressures on individuals, families, communities, and… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer, Chemotherapy-induced Leukopenia, Chinese Herb Medicine-moxibustion
- What is being tested?
- moxibustion and Chinese herbal medicine group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Mar 2024to 31 Dec 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with cancer by Western medicine doctors.
- regardless of cancer type, gender.
- aged 20 or above, experiencing WBC < 3000/μL or ANC < 1500/μL for the first time after starting chemotherapy.
Who cannot join
- Patients not suitable for moxibustion, including those with wounds at moxibustion points.
- Patients who refuse to sign the consent form.
- Minors, pregnant women, individuals with mental illnesses, those vulnerable to harm, or in disadvantaged groups.
- Patients with leukemia, where the disease itself affects changes in blood cells.
- Patients currently receiving other forms of Traditional Chinese Medicine treatment or alternative therapies that may increase white blood cell counts.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Armed Force General Hospital
Taichung, Taiping, 411228
ming huei cheng, 0921059072, u9630091@cmu.edu.tw
About this study
Cancer is the second leading cause of death globally, with an estimated 9.6 million deaths in 2018, accounting for one-sixth of total deaths. The economic burden of cancer continues to rise globally, causing significant physiological, psychological, and economic pressures on individuals, families, communities, and healthcare systems. The toxic effects of chemotherapy, such as nausea, vomiting, decreased blood cells, fatigue, etc., can impair patients' function, activities, and quality of life. Chemotherapy-induced leukopenia (CIL), particularly low white blood cell counts (48.9%), is a major concern for cancer patients.
Current conventional treatments primarily involve colony-stimulating factors (G-CSF and GM-CSF) to accelerate neutrophil recovery and regulate granulocyte production. However, G-CSF is costly and adds financial burden, and its use is restricted to cases meeting specific criteria. Additionally, rapid changes in patients' symptoms, weakness, and poor appetite may lead to swift deterioration of their condition, making it challenging to predict and prevent. Moreover, G-CSF has frequent side effects, including skin rash, liver function abnormalities, nausea, vomiting, fever, headache, fatigue, palpitations, and increased levels of ALP, LDH, and uric acid, with bone pain being the most common.
Traditional Chinese Medicine (TCM) has been a long-standing medical practice in Eastern societies and is a legally recognized healthcare option in Taiwan, covered by national health insurance. TCM includes acupuncture, moxibustion, and Chinese herbal medicine, all of which have been researched for their potential in addressing chemotherapy-induced leukopenia.
Read the detailed description
Nanjing Medical University analyzed a systematic review article 7 of 14 randomized trials of traditional Chinese medicine in improving WBC count, Card-type physical function and quality of life scale (Karnofsky Performance Scale, KPS), infectious dose, and G-CSF use. According to statistics on the rate and incidence of leukopenia, it was found that CHM chemotherapy was adjusted to use western medicine plus chemotherapy. However, clinical considerations suggest that some patients with low leukocytes have poor cosmetics and are unable to meet the three-times-a-day dosage. A review of the literature found that traditional Chinese medicine powder is applied to acupoints to treat various diseases, such as primary menstrual pain 8 and chronic obstructive pulmonary disease 9 , Vomiting after general anesthesia for orthopedic surgery 10 may be treated. There are 4 articles on the Chinese Journal online using traditional Chinese medicine to treat adverse reactions after chemotherapy, including grinding traditional Chinese medicine into paste and applying it to acupoints to improve mixed leukopenia11; analysis of the correlation between traditional Chinese medicine acupoint application in the treatment of malignant tumors from 2010 to 2020 Literature, statistics on commonly used Chinese medicines, acupoints and preparation methods, found that acupoint application can improve leukopenia, constipation, vomiting and other adverse reactions in cancer patients after chemotherapy12; Chinese medicine powder mixed with petroleum jelly and applied to acupoints combined with Chinese medicine liquid injection can improve platinum Chemotherapy drugs cause vomiting, ointment, constipation, low liver function and low blood cells13; using Guilu Erxian glue patch directly improves low white blood cells and neutrophils after chemotherapy for intestinal cancer14. Therefore, local topical traditional Chinese medicine application therapy is not used for research design.
- Being tested
- moxibustion and Chinese herbal medicine group
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moxibustion and Chinese herbal medicine groupOther
Also called sham moxibustion and placebo herbal medicine group
Apply 15g of Chinese herbal powder (a mixture of scientific Chinese herbs: Jiseng Shenqi Pill, Xuanfu Daizheshi Tang, and Wendi Tang mixed in a 1:1:1 ratio, mixed with water to form a paste) to the Shénquè acupoint. Then, use 3g of 80:1 moxa wool placed in a moxibustion box for moxibustion on the lower abdomen (between the Guānyuán, Zhōngjí, and Shénquè acupoints) for 1 hour, once a day, six times a week, for a total of 12 sessions.
sham moxibustion and placebo herbal medicine group): Same acupoint frequency, but use 15g of flour instead of herbal paste and replace moxibustion with a heated nightlight for sham moxibustion.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (moxibustion and Chinese herbal medicine group) | Experimental | Not described Receives: Other: moxibustion and Chinese herbal medicine group |
| Control group (sham moxibustion and placebo herbal medicine group) | Placebo comparator | Not described Receives: Other: moxibustion and Chinese herbal medicine group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Track the number of white blood cells
Track the number of white blood cells, absolute neutrophils, in the "Complete blood count (CBC)" before and after the test.
Measured: 1. Baseline, before the first treatment. 2. 2 weeks after complete twelve treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start13 Mar 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, Chemotherapy-induced Leukopenia, Chinese Herb Medicine-moxibustionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Armed Forces General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Cheng Ming Huei, Taichung Armed Forces General Hospital
- Investigators
- Ming-Huei Cheng, Principal investigator, TAICHUNG ARMED FORCED GENERAL HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262542
- Sponsor's protocol ID
- 111016
- Status last verified
- Apr 2024
- First submitted
- 5 Feb 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Chinese Herb Medicine-Moxibustion Therapy on Chemotherapy-Induced Leukopenia
- ClinicalTrials.gov ID
- NCT06262542
- Acronym / sponsor ID
- 111016
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taichung Armed Forces General HospitalOther government
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Feb 2024 (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.
Cancer is the second leading cause of death globally, with an estimated 9.6 million deaths in 2018, accounting for one-sixth of total deaths. The economic burden of cancer continues to rise globally, causing significant physiological, psychological, and economic pressures on individuals, families, communities, and healthcare systems. The toxic effects of chemotherapy, such as nausea, vomiting, decreased blood cells, fatigue, etc., can impair patients' function, activities, and quality of life. Chemotherapy-induced leukopenia (CIL), particularly low white blood cell counts (48.9%), is a major concern for cancer patients.
Current conventional treatments primarily involve colony-stimulating factors (G-CSF and GM-CSF) to accelerate neutrophil recovery and regulate granulocyte production. However, G-CSF is costly and adds financial burden, and its use is restricted to cases meeting specific criteria. Additionally, rapid changes in patients' symptoms, weakness, and poor appetite may lead to swift deterioration of their condition, making it challenging to predict and prevent. Moreover, G-CSF has frequent side effects, including skin rash, liver function abnormalities, nausea, vomiting, fever, headache, fatigue, palpitations, and increased levels of ALP, LDH, and uric acid, with bone pain being the most common.
Traditional Chinese Medicine (TCM) has been a long-standing medical practice in Eastern societies and is a legally recognized healthcare option in Taiwan, covered by national health insurance. TCM includes acupuncture, moxibustion, and Chinese herbal medicine, all of which have been researched for their potential in addressing chemotherapy-induced leukopenia.
Detailed description
Nanjing Medical University analyzed a systematic review article 7 of 14 randomized trials of traditional Chinese medicine in improving WBC count, Card-type physical function and quality of life scale (Karnofsky Performance Scale, KPS), infectious dose, and G-CSF use. According to statistics on the rate and incidence of leukopenia, it was found that CHM chemotherapy was adjusted to use western medicine plus chemotherapy. However, clinical considerations suggest that some patients with low leukocytes have poor cosmetics and are unable to meet the three-times-a-day dosage. A review of the literature found that traditional Chinese medicine powder is applied to acupoints to treat various diseases, such as primary menstrual pain 8 and chronic obstructive pulmonary disease 9 , Vomiting after general anesthesia for orthopedic surgery 10 may be treated. There are 4 articles on the Chinese Journal online using traditional Chinese medicine to treat adverse reactions after chemotherapy, including grinding traditional Chinese medicine into paste and applying it to acupoints to improve mixed leukopenia11; analysis of the correlation between traditional Chinese medicine acupoint application in the treatment of malignant tumors from 2010 to 2020 Literature, statistics on commonly used Chinese medicines, acupoints and preparation methods, found that acupoint application can improve leukopenia, constipation, vomiting and other adverse reactions in cancer patients after chemotherapy12; Chinese medicine powder mixed with petroleum jelly and applied to acupoints combined with Chinese medicine liquid injection can improve platinum Chemotherapy drugs cause vomiting, ointment, constipation, low liver function and low blood cells13; using Guilu Erxian glue patch directly improves low white blood cells and neutrophils after chemotherapy for intestinal cancer14. Therefore, local topical traditional Chinese medicine application therapy is not used for research design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (moxibustion and Chinese herbal medicine group) | Experimental | Other: moxibustion and Chinese herbal medicine group |
| Control group (sham moxibustion and placebo herbal medicine group) | Placebo comparator | Other: moxibustion and Chinese herbal medicine group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with cancer by Western medicine doctors.
- regardless of cancer type, gender.
- aged 20 or above, experiencing WBC < 3000/μL or ANC < 1500/μL for the first time after starting chemotherapy.
Key exclusion criteria (5 listed)
- Patients not suitable for moxibustion, including those with wounds at moxibustion points.
- Patients who refuse to sign the consent form.
- Minors, pregnant women, individuals with mental illnesses, those vulnerable to harm, or in disadvantaged groups.
- Patients with leukemia, where the disease itself affects changes in blood cells.
- Patients currently receiving other forms of Traditional Chinese Medicine treatment or alternative therapies that may increase white blood cell counts.
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 |
|---|---|---|
| moxibustion and Chinese herbal medicine groupAlso: sham moxibustion and placebo herbal medicine groupApply 15g of Chinese herbal powder (a mixture of scientific Chinese herbs: Jiseng Shenqi Pill, Xuanfu Daizheshi Tang, and Wendi Tang mixed in a 1:1:1 ratio, mixed with water to form a paste) to the Shénquè acupoint. Then, use 3g of 80:1 moxa wool placed in a moxibustion box for moxibustion on the lower abdomen (between the Guānyuán, Zhōngjí, and Shénquè acupoints) for 1 hour, once a day, six times a week, for a total of 12 sessions. sham moxibustion and placebo herbal medicine group): Same acupoint frequency, but use 15g of flour instead of herbal paste and replace moxibustion with a heated nightlight for sham moxibustion. | Other | Control group (sham moxibustion and placebo herbal medicine group), Experimental group (moxibustion and Chinese herbal medicine group) |
Primary outcome
Track the number of white blood cells
Time frame: 1. Baseline, before the first treatment. 2. 2 weeks after complete twelve treatment.
Track the number of white blood cells, absolute neutrophils, in the "Complete blood count (CBC)" before and after the test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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.
Ming-Huei Cheng principal investigator
TAICHUNG ARMED FORCED GENERAL HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing moxibustion and Chinese herbal medicine group in people with Cancer, Chemotherapy-induced Leukopenia, Chinese Herb Medicine-moxibustion, run by Taichung Armed Forces General Hospital 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 5 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: status not confirmed, as of the sponsor's last update on 12 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Sing Tsai (886-4-25271180, wensing@fyh.mohw.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Track the number of white blood cells (time frame: 1. Baseline, before the first treatment. 2. 2 weeks after complete twelve treatment.). 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 12 Apr 2024.