RecruitingNot ApplicableNCT06262542

Efficacy and Safety of Chinese Herb Medicine-Moxibustion Therapy on Chemotherapy-Induced Leukopenia


Sponsor

Taichung Armed Forces General Hospital

Enrollment

60 participants

Start Date

Mar 13, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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.

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Interventions

OTHERmoxibustion and Chinese 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.


Locations(1)

Taichung Armed Force General Hospital

Taichung, Taiping, Taiwan

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NCT06262542