Trial Radar IA | ||
|---|---|---|
Lo studio clinico NCT06952920 per standard quadruple antiemetic therapy, Elettro-agopuntura, Chemotherapy-induced Gastrointestinal Symptom Cluster è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
Un studio corrisponde ai criteri del filtro
Vista a schede
Electroacupuncture for Chemotherapy-Induced GI Symptom Clusters in Breast Cancer Fase III 388
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT06952920 è uno studio interventistico di Fase III volto a esaminare la prevenzione per standard quadruple antiemetic therapy, Elettro-agopuntura, Chemotherapy-induced Gastrointestinal Symptom Cluster, attualmente in arruolamento. Avviato il 21 agosto 2025, prevede di arruolare 388 partecipanti. Sotto la guida di Jiuda Zhao, dovrebbe concludersi entro il 30 giugno 2028. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 15 dicembre 2025.
Sommario breve
This study aims to elucidate the therapeutic efficacy of electroacupuncture in managing chemotherapy-induced gastrointestinal symptom clusters through clinical research. Building upon this foundation, multi-omics analyses will be conducted to investigate the regulatory effects and underlying mechanisms of electroacupuncture on gastrointestinal symptoms. Ultimately, genomic studies will be performed to further clarify...Mostra di più
Descrizione dettagliata
This prospective, multicenter, randomized, double-blind, sham-controlled trial investigates the efficacy of electroacupuncture (EA) combined with standard quadruple antiemetic therapy (olanzapine + dexamethasone + 5-HT3 receptor antagonist + NK-1 receptor antagonist) versus sham EA plus identical antiemetic regimen for chemotherapy-induced gastrointestinal symptom clusters (nausea, vomiting, poor appetite, and xerost...Mostra di più
Titolo ufficiale
Electroacupuncture for Managing Chemotherapy-Induced Gastrointestinal Symptom Clusters in Patients With Breast Cancer
Patologie
standard quadruple antiemetic therapyElettro-agopunturaChemotherapy-induced Gastrointestinal Symptom ClusterPubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- AHQU-2025002
Numero NCT
Data di inizio (effettiva)
2025-08-21
Ultimo aggiornamento pubblicato
2025-12-15
Data di completamento (stimata)
2028-06-30
Arruolamento (previsto)
388
Tipo di studio
Interventistico
FASE
Fase III
Stato
In arruolamento
Parole chiave
breast cancer
chemotherapy
standard quadruple antiemetic therapy
electroacupuncture
chemotherapy-induced gastrointestinal symptom cluster
chemotherapy
standard quadruple antiemetic therapy
electroacupuncture
chemotherapy-induced gastrointestinal symptom cluster
Scopo principale
Prevenzione
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Triplo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Sperimentaletrue acupuncture + standard quadruple antiemetic therapy The experimental group received electroacupuncture (EA) combined with a standard quadruple antiemetic regimen comprising Olanzapine (2.5 mg orally daily, days 1-4), dexamethasone (10 mg intravenously day 1; 7.5 mg intravenously days 2-3), a 5-HT₃ antagonist (palonosetron 0.25 mg intravenously or 0.5 mg orally, or ondansetron 8 mg intravenously or 8 mg orally twice, or tropisetron 5 mg intravenously, all on day 1), an...Mostra di più | Elettroagopuntura The acupuncturist applied needles at four acupoints: Zusanli (ST36), Neiguan (PC6), Hegu (LI4), and Zhaohai (KI6), with insertion depths of approximately 20 mm, 15 mm, 20 mm, and 5 mm respectively. Electrical stimulation was delivered in continuous wave mode at 2 Hz frequency with current intensity ≤10 mA (adjusted according to patient tolerance), administered for 30 minutes per session. standard quadruple antiemetic therapy Olanzapine (2.5 mg orally daily, days 1-4), dexamethasone (10 mg intravenously day 1; 7.5 mg intravenously days 2-3), a 5-HT₃ antagonist (palonosetron 0.25 mg intravenously or 0.5 mg orally, or ondansetron 8 mg intravenously or 8 mg orally twice, or tropisetron 5 mg intravenously, all on day 1), and an NK₁ antagonist (fosaprepitant 150 mg intravenously, or aprepitant 130 mg intravenously, or oral aprepitant 125 mg da...Mostra di più |
Comparatore placebosham acupuncture + standard quadruple antiemetic therapy The control group received sham electroacupuncture combined with the identical standard quadruple antiemetic regimen (drug components and dosages identical to the experimental group). The sham intervention protocol consisted of: (1) superficial needle insertion at non-acupoint locations adjacent to the authentic acupoints (ST36, PC6, LI4, and KI6); (2) attachment of non-functional electrodes using deactivated electro...Mostra di più | Elettroagopuntura fittizia The same acupoints as the electroacupuncture group were referenced, but with sham acupuncture (minimal insertion at non-acupoint locations) and sham electrical stimulation, while maintaining the same treatment duration and course as the electroacupuncture group. standard quadruple antiemetic therapy Olanzapine (2.5 mg orally daily, days 1-4), dexamethasone (10 mg intravenously day 1; 7.5 mg intravenously days 2-3), a 5-HT₃ antagonist (palonosetron 0.25 mg intravenously or 0.5 mg orally, or ondansetron 8 mg intravenously or 8 mg orally twice, or tropisetron 5 mg intravenously, all on day 1), and an NK₁ antagonist (fosaprepitant 150 mg intravenously, or aprepitant 130 mg intravenously, or oral aprepitant 125 mg da...Mostra di più |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
The incidence of chemotherapy-induced gastrointestinal symptom clusters, including nausea, vomiting, poor appetite, and xerostomia, within 120 hours after chemotherapy. | 120 hours |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Improvement in other gastrointestinal symptom clusters after the first cycle of chemotherapy. | 120 hours | |
The incidence of no nausea during the acute and delayed phases following the first chemotherapy cycle. | 120 hours | |
The incidence of no vomiting during the overall, acute, and delayed phases following the first chemotherapy cycle. | 120 hours | |
Complete response rates in the overall, acute, and delayed phases following the first chemotherapy cycle. | 120 hours | |
Complete protection rates in the overall, acute, and delayed phases following the first chemotherapy cycle. | 120 hours | |
Quality of life assessed by the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L). | The EQ-5D-5L evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored from 1 ("no problems") to 5 ("extreme problems"), with health states expressed as 5-digit codes (e.g., 11111=no impairment; 55555=extreme impairment across all dimensions). Index scores were calculated using the Chinese value set (Luo et al., 2017), yielding a theoretical range of -0.391 (worse than death) to 1.0 (perfect health). The visual analogue scale (VAS) component records self-rated health status from 0 ("worst imaginable health") to 100 ("best imaginable health"). | 120 hours |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Pathologically confirmed stage I-III breast cancer;
- An Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1;
- Age between 18 and 75 years;
- Scheduled to receive highly emetogenic chemotherapy regimens, such as EC (epirubicin + cyclophosphamide) or platinum-based regimens, during the first cycle of neoadjuvant/adjuvant chemotherapy;
- No prior acupuncture treatment within one month before enrollment;
- Voluntary participation in the study with written informed consent obtained; (7) An expected survival of at least 3 months;
(8) Premenopausal women must agree to use contraception during the study period; (9) Adequate bone marrow, liver, and kidney function as defined by standard laboratory criteria.
- Patients with advanced-stage cancer;
- Those undergoing concurrent chemoradiotherapy;
- Individuals with severe impairment of vital organ function who cannot tolerate standard-dose chemotherapy;
- Patients with contraindications to acupuncture, such as active skin infections;
- Those with digestive system diseases accompanied by nausea and vomiting symptoms that may interfere with accurate assessment;
- Patients with a history of xerostomia;
- Individuals with known allergies to the study drugs;
- Pregnant or breastfeeding patients;
- Individuals currently using medications with antiemetic activity, such as 5-HT3 receptor antagonists, corticosteroids (except at physiological doses), dopamine receptor antagonists, minor tranquilizers, antihistamines, and benzodiazepines (except for nighttime sedation);
- Patients with seizure disorders requiring anticonvulsant therapy;
- Those receiving thiazides as chronic antipsychotic medications;
- Those with known arrhythmias, uncontrolled congestive heart failure, or acute myocardial infarction.
Jiuda ZhaoParte responsabile dello studio
Jiuda Zhao, Promotore-investigatore, Clinical Professor, Affiliated Hospital of Qinghai University
Nessun dato di contatto
1 Centri dello studio in 1 paesi
Qinghai
Qinghai University Affiliated Hospital, Xining, Qinghai, 810000, China
Jiuda Zhao，Dr, Contatto, 869716230893, [email protected]
In arruolamento