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Trial Radar IA
Lo studio clinico NCT06314906 per Elettro-agopuntura, Antiemetico a quattro farmaci contenente olanzapina, Nausea e Vomito 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.
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Electroacupuncture Plus Antiemetic Therapy for Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer Fase III 370

In arruolamento
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 NCT06314906 è uno studio interventistico di Fase III volto a esaminare il trattamento per Elettro-agopuntura, Antiemetico a quattro farmaci contenente olanzapina, Nausea e Vomito, attualmente in arruolamento. Avviato il 7 marzo 2024, prevede di arruolare 370 partecipanti. Sotto la guida di Feixue Song, dovrebbe concludersi entro il 31 marzo 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 21 marzo 2024.
Sommario breve
This study explores the effectiveness of combining electroacupuncture with olanzapine-containing four-drug antiemetic therapy to mitigate chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer. The research aims to assess the adjunctive benefits of electroacupuncture in enhancing the antiemetic effects of conventional medication, particularly in the context of highly emetogenic chemotherapy re...Mostra di più
Descrizione dettagliata
This study is a randomized controlled trial conducted in parallel groups, with blinding implemented. It aims to assess the effectiveness of combining electroacupuncture with standard quadruple antiemetic drugs for patients with breast cancer undergoing HEC.

Both study arms will be administered Olanzapine, Neurokinin-1 receptor antagonists, serotonin receptor antagonists, and dexamethasone at the commencement of HEC ...

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Titolo ufficiale

Combining Electroacupuncture With Antiemetic Therapy for Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Breast Cancer: A Clinical Study

Patologie
Elettro-agopunturaAntiemetico a quattro farmaci contenente olanzapinaNausea e Vomito
Altri ID dello studio
  • SHLU-2024001
Numero NCT
NCT06314906
Data di inizio (effettiva)
2024-03-07
Ultimo aggiornamento pubblicato
2024-03-21
Data di completamento (stimata)
2027-03-31
Arruolamento (previsto)
370
Tipo di studio
Interventistico
FASE
Fase III
Stato
In arruolamento
Parole chiave
electroacupuncture
olanzapine-contained four-drug antiemetic
nausea and Vomiting
breast cancer
chemotherapy
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Triplo
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentaleTrue Acupuncture Combined with Antiemetic Therapy
Participants in this arm will undergo electroacupuncture sessions once daily from day 1 to day 4. Electrical stimulation will be administered for 30 minutes at alternating frequencies of 2/10Hz.
Elettroagopuntura
Participants in this arm will undergo electroacupuncture sessions once daily from day 1 to day 4. Electrical stimulation will be administered for 30 minutes at alternating frequencies of 2/10Hz
Antiemetic Therapy
Participants will receive oral olanzapine at a dose of 5 mg per day on days 1 through 4, along with NK1 receptor antagonist, 5HT3 receptor antagonist, and intravenous dexamethasone at a dose of 10 mg 30 minutes prior to chemotherapy on Day 1, followed by intravenous dexamethasone at a dose of 8 mg on days 2, 3, and 4 post-chemotherapy.
Comparatore placeboAntiemetic therapy
Participants assigned to this arm will receive sham electroacupuncture sessions daily from day 1 to day 4, mirroring the schedule of the experimental group. They will also receive the same antiemetic medications as the experimental group.
Elettroagopuntura fittizia
Participants assigned to this arm will receive sham electroacupuncture sessions daily from day 1 to day 4, mirroring the schedule of the experimental group
Antiemetic Therapy
They will also receive the same antiemetic medications as the experimental group.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Proportion of Patients Free from Nausea Throughout Treatment
The proportion of patients experiencing no nausea is determined by those who register a score of 0 on the visual-analogue scale for nausea throughout the entirety of treatment, spanning from initiation of chemotherapy to 120 hours post-treatment.
120 hours
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
Accetta volontari sani
Sì
  1. Patients aged 18 to 75 years, inclusive, from any nationality.
  2. Patients diagnosed with early-stage breast cancer.
  3. Eastern Cooperative Oncology Group performance status ranging from 0 to 2.
  4. All patients must undergo highly emetogenic chemotherapy (HEC).
  5. Adequate organ function.
  6. Adequate contraception required for premenopausal women.

  1. Scheduled to undergo chemotherapy between days 2 to 4 following HEC.
  2. Received or is planned to receive abdominal radiation therapy within 1 week before Day 1 in cycle 1.
  3. Significant medical or psychological conditions.
  4. Presents with symptomatic primary or metastatic central nervous system malignancy causing nausea and/or vomiting.
  5. Experiencing ongoing vomiting or nausea of grade 2 or higher according to Common Terminology Criteria for Adverse Events (CTCAE).
  6. Any known allergies to the study drug, antiemetics, or dexamethasone.
  7. Patients who have fear of electroacupuncture stimulation or are allergic to stainless steel needles.
  8. Received acupuncture treatments for any conditions within 8 weeks prior to HEC.
Feixue Song logoFeixue Song
Parte responsabile dello studio
Feixue Song, Promotore-investigatore, Professor, Lanzhou University Second Hospital
Contatti principali dello studio
Contatto: Feixue Song, Dr, 13639336037, [email protected]
1 Centri dello studio in 1 paesi

Gansu

Second Hospital of Lanzhou University, Lanzhou, Gansu, 730000, China
Feixue Song, Dr, Contatto, 13639336037, [email protected]
In arruolamento