Trial Title:
Efficacy and Safety of Chinese Herb Medicine-Moxibustion Therapy on Chemotherapy-Induced Leukopenia
NCT ID:
NCT06262542
Condition:
Cancer, Chemotherapy-induced Leukopenia, Chinese Herb Medicine-moxibustion
Conditions: Official terms:
Leukopenia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Other
Intervention name:
moxibustion and Chinese herbal medicine group
Description:
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.
Arm group label:
Control group (sham moxibustion and placebo herbal medicine group)
Arm group label:
Experimental group (moxibustion and Chinese herbal medicine group)
Other name:
sham moxibustion and placebo herbal medicine group
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Taichung Armed Force General Hospital
Address:
City:
Taichung
Zip:
411228
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
ming huei cheng
Phone:
0921059072
Email:
u9630091@cmu.edu.tw
Start date:
March 13, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Taichung Armed Forces General Hospital
Agency class:
Other
Source:
Taichung Armed Forces General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06262542
