Clinical trial NCT06262542: Efficacy and Safety of Chinese Herb Medicine-Moxibustion Therapy on Chemotherapy-Induced Leukopenia
Official title: Efficacy and Safety of Chinese Herb Medicine-Moxibustion Therapy on Chemotherapy-Induced Leukopenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer, Chemotherapy-induced Leukopenia, Chinese Herb Medicine-moxibustion
Lead sponsor: Taichung Armed Forces General Hospital
Sponsor class: OTHER_GOV
First posted: 2024-02-16
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Track the number of white blood cells
timeFrame: 1. Baseline, before the first treatment. 2. 2 weeks after complete twelve treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Armed Force General Hospital
state: Taiping
Study officials:
affiliation: TAICHUNG ARMED FORCED GENERAL HOSPITAL
name: Ming-Huei Cheng
role: PRINCIPAL_INVESTIGATOR
References: