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

NCT06262542 | Recruiting

• 1 other identifier: 111016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer, Chemotherapy-induced Leukopenia, Chinese Herb Medicine-moxibustion

Outcome Measures

Primary Outcomes (1)

• 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.

  1. Baseline, before the first treatment. 2. 2 weeks after complete twelve treatment.

Study Arms (2)

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

Interventions

moxibustion and Chinese herbal medicine group OTHER

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.

Also known as: sham moxibustion and placebo herbal medicine group

Control group (sham moxibustion and placebo herbal medicine group); Experimental group (moxibustion and Chinese herbal medicine group)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taichung Armed Forces General Hospital: lead

Study Sites (1)

Taichung Armed Force General Hospital

Taichung, Taiping, 411228, Taiwan

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Moxibustion

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics

Study Officials

• Ming-Huei Cheng

  TAICHUNG ARMED FORCED GENERAL HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen-Sing Tsai

CONTACT

886-4-25271180; wensing@fyh.mohw.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 16, 2024
• Study Start: March 13, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)