Efficacy and Safety of Heated Chinese Herb Medicine Patch Therapy on Chemotherapy-Induced Aplastic Anemia
The objective of this clinical trial is to establish a treatment for chemotherapy-induced pancytopenia symptoms using heated traditional Chinese medicine (TCM) plasters through a randomized, single-blind clinical trial.
The primary question it aims to answer is whether heated TCM plasters improve chemotherapy-induced pancytopenia symptoms, maintain or increase white blood cells, platelets, and red blood cells, reduce the use of G-CSF and blood transfusions, and enhance cancer patients' quality of life. It also aims to assess if there are any adverse patient reactions to this treatment.
The researchers will compare heated TCM plasters with placebo heated/plaster, placebo TCM plasters, and placebo heated TCM plasters to determine whether the treatment improves chemotherapy-induced pancytopenia symptoms.
Participants will apply the plaster for 1 hour, once daily, 6 days a week for 2 consecutive weeks, totaling 12 applications. Full blood tests (Complete Blood Count, CBC) and white blood cell differential count (DC) will be performed before and after the treatment, and participants will complete the FACT-G cancer treatment-related quality of life scale.
Обзор исследования
Статус
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Taiping District
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Taichung, Taiping District, Тайвань, 411228
- Taichung armed forces gereral hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
Patients were eligible if they were:
(i) had a diagnosis of stage I-IV cancer. (ii) be aged 20 years or older. (iii)hematological dysfunction: have experienced a WBC count of <4000/μL or ANC <1500/μL after starting chemotherapy.
(iv) can understand and voluntarily sign the informed consent form t
Exclusion Criteria:
The following conditions disqualify participants from the study:
(i) Patients who are unsuitable for moxibustion, including those with wounds at the moxibustion site.
(ii)Individuals who refuse to sign the informed consent form. (iii) Minors, pregnant women, individuals with mental illnesses, those at risk of harm, or vulnerable groups.
(iv)Leukemia patients, as the disease itself affects blood cell changes. (v) Those who have used leukopoietic agents or received blood transfusions within the past month.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Фальшивый компаратор: Control group (sham heated TCM plaster group)
No heat source, no TCM plaster group
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The same acupuncture points and frequency are used, but instead of the medicinal cake, 5g of flour colored with caramel dye is applied.
An unlit moxa column is placed in a moxibustion box to serve as a placebo heat source.
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Экспериментальный: Experimental group (Heated TCM plaster group)
Heat source + TCM plaster group
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Each time, 5g of the medicinal powder is combined with 7g of tap water and applied to gauze to form a medicinal cake.
The researcher then places it on the Shenque point (International acupuncture point code: RN8).
Additionally, a 3g moxa column with a 80:1 moxa wool ratio is ignited and placed in a moxibustion box to generate heat, which is layered over the medicinal cake for 1 hour.
The treatment is applied once a day, 6 days a week, for 2 consecutive weeks, totaling 12 sessions.
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Плацебо Компаратор: Heat source without TCM plaster group
heat source, no TCM plaster group
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Only 3g of moxa wool (80:1 ratio) is ignited and placed in a moxibustion box to generate heat.
The researcher directly applies it to the Shenque point for 1 hour, once a day, 6 days a week for 2 consecutive weeks, totaling 12 sessions.
(If the participant feels it's too hot, they can either move the moxa wool around the Shenque point themselves or ask the researcher to do so to avoid burns.)
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Плацебо Компаратор: No heat source with TCM plaster group
no heat source, but TCM plaster group
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Only a TCM medicinal cake is applied to the Shenque point, with no heat source or moxibustion box used.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of participants with abnormal blood tests results
Временное ограничение: Before the intervention (baseline, Day 1) and within 3 days after completion of the 12 intervention sessions(2 weeks).
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A complete blood count (CBC) and differential count (DC) will be performed by the hospital's Department of Laboratory Medicine.
A 3 mL blood sample will be collected before and after the intervention, for a total of two blood draws.
The test items are as follows:
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Before the intervention (baseline, Day 1) and within 3 days after completion of the 12 intervention sessions(2 weeks).
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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"Traditional Chinese Medicine Constitution Questionnaire"
Временное ограничение: Before the intervention (baseline, Day 1)
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Before the intervention (baseline, Day 1)
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"FACT-G Quality of Life Questionnaire for Cancer Patients (Version 4)"
Временное ограничение: Before the intervention (baseline, Day 1) and after completion of the 12 intervention sessions (2 weeks)
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The Functional Assessment of Cancer Therapy-General Questionnaire(FACT-G)comprises 27 questions that assess four primary dimensions of QOL: physical (PWB; 7 items), social and family (SFWB; 7 items), emotional (EWB; 6 items), and functional well-being (FWB; 7 items).
It uses 5-point Likert-type response categories ranging from 0 = 'not at all' to 4 = 'very much'.
The total FACT-G score is the summation of the 4 subscale scores and ranges from 0 to 108.
The higher scores in FACT-G mean a better or worse outcome.
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Before the intervention (baseline, Day 1) and after completion of the 12 intervention sessions (2 weeks)
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the number of G-CSF
Временное ограничение: the number of G-CSF used during the 12 intervention sessions period (at the end of this cycle, the cycle is 14 days).
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the number of G-CSF used during the 12 intervention sessions period (at the end of this cycle, the cycle is 14 days).
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the number of blood transfusions
Временное ограничение: the number of blood transfusions used during the 12 intervention sessions period (at the end of this cycle, the cycle is 14 days).
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the number of blood transfusions used during the 12 intervention sessions period (at the end of this cycle, the cycle is 14 days).
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CMUH114-REC3-063
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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