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.
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Taiping District
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Taichung, Taiping District, Taiwan, 411228
- Taichung armed forces gereral hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore fittizio: 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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Sperimentale: 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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Comparatore placebo: 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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Comparatore placebo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of participants with abnormal blood tests results
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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"Traditional Chinese Medicine Constitution Questionnaire"
Lasso di tempo: 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)"
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CMUH114-REC3-063
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