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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-13

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Radioprotective Effect of Chinese Herbal Medicine on Oral Mucositis

NCT05040425

Head and Neck Cancer Oral Mucositis

UNKNOWN PHASE2

The Effect of Jin Si Herbal Tea on Cancer-related Fatigue of Gynecological Cancer Patients

NCT05454865

COMPLETED NA

Effects for Oral Mucositis Care During Chemoradiotherapy in Cancer Patients: Evaluation of the Bee Products

NCT05625841

Oral Mucositis

UNKNOWN NA

Evaluation the Effects of Herbal Gargle for Chemoradiotherapy-induced Oral Mucositis of Head & Neck Cancer, a Pilot Study.

NCT05341206

Head and Neck Neoplasms Chemoradiotherapy Stomatitis and Ulceration

NOT_YET_RECRUITING PHASE2

Evaluating Chinese Medicine Oral Rinse for Irradiated Oral Mucositis in Head & Neck Cancer Patients

NCT05664906

Head and Neck Neoplasms Oral Mucositis (Ulcerative) Due to Radiation Chinese Medicine Oral Rinse

UNKNOWN PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group (moxibustion and Chinese herbal medicine group)

Group Type EXPERIMENTAL

moxibustion and Chinese herbal medicine group

Intervention Type 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.

Control group (sham moxibustion and placebo herbal medicine group)

Group Type PLACEBO_COMPARATOR

moxibustion and Chinese herbal medicine group

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

moxibustion 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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

sham moxibustion and placebo herbal medicine group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No