- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02403037
Auricular Acupressure for Chemotherapy-Induced Nausea and Vomiting in Female Breast Cancer Patients
The Effects of Auricular Acupressure on Chemotherapy-Induced Nausea and Vomiting in Female Breast Cancer Patients: A Pilot Randomized Controlled Trial
To evaluate the feasibility of a three-parallel-arm, placebo-controlled randomized trial using a standard auricular acupressure protocol for managing nausea and vomiting in a homogenous group of female breast cancer patients undergoing chemotherapy.
The null hypotheses of this study are: (1) There will be no significant difference in acute/delayed nausea and vomiting among groups during the intervention period; (2) There will be no significant difference in anticipatory nausea and vomiting among groups before the second cycle of chemotherapy; (3) There will be no significant difference in quality of life status among groups at the end of the first cycle of chemotherapy.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Chemotherapy-induced nausea and vomiting (CINV) is one of the most common and distressing side-effects among cancer patients undergoing chemotherapy. Despite steady progresses in antiemetic prophylaxis and treatment during the past decades, approximately half of cancer patients receiving moderately to highly emetogenic chemotherapy still experience significant nausea and vomiting. Considering the facts that CINV is difficult to be completely controlled by antiemetics along, healthcare professionals has explored the role of non-pharmacological interventions as adjunctive therapy for controlling CINV. Among which, auricular therapy (AT) is a promising approach but the evidence has still not been concluded.
The aim of this study is to test the feasibility of a randomized controlled trial using auricular acupressure protocol for managing nausea and vomiting in female breast cancer patients undergoing chemotherapy. The objectives of this study will be: (1) to pilot the methodological procedure of the randomized controlled trial using a standard auricular acupressure protocol for controlling CINV; (2) to determine the recruitment rate and attrition rate during the whole study period; (3) to determine the feasibility of the study questionnaires and auricular acupressure protocol to the study participants; (4) to identify potential adverse events associated with auricular acupressure; (5) to preliminarily examine the effects of auricular acupressure on CINV and QoL in female breast cancer patients receiving chemotherapy; (6) to explore patients' experience in completing the trial and receiving the intervention; and (7) to refine the study protocol for a future multicenter, large-scale randomized controlled trial.
A three-parallel-arm, placebo-controlled randomized pilot study will be adopted. One hundred and fourteen breast cancer patients scheduled to receive the first cycle of chemotherapy will be recruited from three provincial hospitals in Fuzhou, China, and will be randomly assigned to one of the three groups: the true AT group, the sham AT group or the standard care group. Participants in the true AT group will receive standard anti-emetic medications plus a 5-day auricular acupressure at the specific ear acupoints, participants in the sham AT group will receive standard anti-emetic medications plus a 5-day auricular acupressure at the same acupoints as in the true AT group without any acupoint stimulation, while participants in the standard care group will only be provided with the standard anti-emetic medications. The feasibility outcomes will be the recruitment rate and consent rate during the recruitment stage, the attrition rate during the whole study period, feasibility of the study questionnaires and auricular acupressure protocol to the study participants, and AT-related adverse events. The future main study outcomes will also be measured including acuteCINV, delayed CINV, anticipatory CINV, and quality of life. After completing the pilot clinical trial, a nested qualitative interview will be conducted to explore participants' experience in completing the trial and receiving the intervention.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Fujian
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Fuzhou, Fujian, Cina, 350014
- Fujian Provincial Cancer Hospital
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Fuzhou, Fujian, Cina, 350003
- The Second People's Hospital of Fujian Province
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Fuzhou, Fujian, Cina, 350004
- The First People's Hospital of Fujian Province
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Adult female patients aged above 18 years old;
- A diagnosis of breast cancer stage I-III;
- Chemotherapy- naive;
- Auricular therapy-naive;
- Be able to communicate in Chinese mandarin;
- Have at least completed a primary school education;
- Agree to participate in the study and be willing to give written informed consent;
- Be scheduled to receive the first cycle of chemotherapy with moderately-high to highly emetogenic potentials;
- Be provided with standard antiemetic medications during chemotherapy.
Exclusion Criteria:
- Extremely weak, disabled or immunocompromised cancer patients;
- Be unable to follow the study instructions to do AT intervention or other research procedures;
- Have concurrent radiotherapy or other kinds of antineoplastic therapy;
- Currently take part in clinical studies on anti-emetic medications or other kinds of non-pharmacological interventions to control CINV, or other studies which are believed to produce potential interactions with this AT trial;
- Have other health problems which may affect the symptoms of CINV such as gastrointestinal disease, liver disease, migraine, tinnitus and Ménière's disease, etc.;
- Ear skin problems which are not appropriate for auricular acupressure including ear infections, ear scars and rashes, ear frostbite, and ear abscess, etc.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: True Auricular Acupressure Group
Participants in this group will receive standard antiemetics before and during chemotherapy, and a 5-day auricular acupressure treatment protocol for controlling nausea and vomiting during the first cycle of chemotherapy.
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A 5-day auricular acupressure at the specific ear acupoints using vaccaria seeds.
Altri nomi:
5-HT3 receptor antagonists and/or Dexamethasone will be administered to manage chemotherapy-induced nausea and vomiting.
Altri nomi:
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Comparatore fittizio: Sham Auricular Acupressure Group
Participants in this group will receive standard antiemetic medications before and during chemotherapy, and a 5-day sham auricular acupressure intervention protocol during the first cycle of chemotherapy.
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5-HT3 receptor antagonists and/or Dexamethasone will be administered to manage chemotherapy-induced nausea and vomiting.
Altri nomi:
A 5-day sham auricular acupressure at the same acupoints as in the true auricular acupressure arm using Junci Medulla but no pressure will be applied.
Altri nomi:
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Altro: Standard Care Group
Participants in this group will only receive standard anti-emetic treatment before and during chemotherapy.
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5-HT3 receptor antagonists and/or Dexamethasone will be administered to manage chemotherapy-induced nausea and vomiting.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Recruitment Rate
Lasso di tempo: Through study completion, an average of 1 year and 4 months
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Feasibility outcome
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Through study completion, an average of 1 year and 4 months
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Consent Rate
Lasso di tempo: Through study completion, an average of 1 year and 4 months
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Feasibility outcome
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Through study completion, an average of 1 year and 4 months
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Attrition Rate
Lasso di tempo: Through study completion, an average of 1 year and 4 months
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Feasibility outcome
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Through study completion, an average of 1 year and 4 months
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Feasibility of the Study Questionnaires and Auricular Acupressure Protocol
Lasso di tempo: Through study completion, an average of 1 year and 4 months
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Feasibility outcome
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Through study completion, an average of 1 year and 4 months
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Potential Adverse Events associated with Auricular Acupressure
Lasso di tempo: During the 5-day intervention period
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Feasibility outcome
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During the 5-day intervention period
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Occurrence of Acute Vomiting
Lasso di tempo: The 2nd day of the first chemotherapy cycle
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Secondary outcome
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The 2nd day of the first chemotherapy cycle
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Frequency of Acute Vomiting
Lasso di tempo: The 2nd day of the first chemotherapy cycle
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Secondary outcome
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The 2nd day of the first chemotherapy cycle
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Occurrence of Acute Nausea
Lasso di tempo: The 2nd day of the first chemotherapy cycle
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Secondary outcome
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The 2nd day of the first chemotherapy cycle
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Severity of Acute Nausea
Lasso di tempo: The 2nd day of the first chemotherapy cycle
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Secondary outcome
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The 2nd day of the first chemotherapy cycle
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Occurrence of Delayed Vomiting
Lasso di tempo: The 6th day of the first chemotherapy cycle
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Secondary outcome
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The 6th day of the first chemotherapy cycle
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Frequency of Delayed Vomiting
Lasso di tempo: The 6th day of the first chemotherapy cycle
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Secondary outcome
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The 6th day of the first chemotherapy cycle
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Occurrence of Delayed Nausea
Lasso di tempo: The 6th day of the first chemotherapy cycle
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Secondary outcome
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The 6th day of the first chemotherapy cycle
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Severity of Delayed Nausea
Lasso di tempo: The 6th day of the first chemotherapy cycle
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Secondary outcome
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The 6th day of the first chemotherapy cycle
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Anticipatory Nausea and Vomiting
Lasso di tempo: The 1st day of the second chemotherapy cycle
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The measure is a composite
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The 1st day of the second chemotherapy cycle
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Quality of Life Status
Lasso di tempo: The 21st day of the first chemotherapy cycle
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Secondary outcome
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The 21st day of the first chemotherapy cycle
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Lorna SUEN, PhD, The Hong Kong Polytechnic University
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
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 (Stima)
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
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie della pelle
- Neoplasie
- Neoplasie per sede
- Segni e sintomi, Digestivo
- Malattie del seno
- Neoplasie mammarie
- Nausea
- Vomito
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Inibitori enzimatici
- Agenti antinfiammatori
- Agenti antineoplastici
- Agenti gastrointestinali
- Glucocorticoidi
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Agenti antineoplastici, ormonali
- Inibitori della proteasi
- Desametasone
- Desametasone acetato
- BB 1101
- Antiemetici
- Emetici
Altri numeri di identificazione dello studio
- HSEARS20150213001
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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