- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02388750
Prospective Study of Palonosetron in Radiation Induced Nausea and Vomiting (RINV)
Prospective Study of Palonosetron in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting (RINV) - a Phase II Study
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
-
Ontario
-
Toronto, Ontario, Canada, M4N3M5
- Odette Cancer Centre, Sunnybrook Health Sciences Centre
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Informed consent
- Patient will receive radiation therapy to considered moderate risk (upper abdomen, upper and half body irradiation) or low risk (lower thorax and pelvis) emetogenic palliative radiotherapy.
Patients will be grouped according to nausea and vomiting status at baseline as follows:
- Group 1: Patient is experiencing no nausea and vomiting at baseline
- Group 2: Patient is experiencing at least mild nausea and/or at least mild vomiting at baseline
Exclusion Criteria:
- Patient is scheduled to receive cranial radiation therapy during or within 10 days following completion of protocol RT.
- Patient received cranial RT within 7 days prior to commencement of protocol RT.
- Patient is scheduled to receive chemotherapy during or within 10 days following completion of protocol RT.
- Patient received moderately or highly emetogenic chemotherapy within 7 days prior to commencement of protocol RT.
- Patient is scheduled to change regimen/dose or start the use of low dose corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic properties within 48 hours prior to protocol RT.
- Patient is scheduled to change regimen/dose or start the use of low dose corticosteroids (inhaled or topical permitted), or other medications considered to have antiemetic properties during or within 10 days following completion of protocol RT.
- Concurrent use of corticosteroids during protocol RT is not permitted, unless low dose corticosteroids (hydrocortisone) are used for cancer treatment
- Patient is allergic to protocol medication.
- Patient has a Karnofsky Performance Status score <40.
- Patient is a woman who is pregnant or of childbearing potential and is not using contraceptive measures.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: No previous nausea and vomiting
Palonosetron 0.5 mg oral capsule given for the length of radiation treatment No previous nausea and vomiting 24 hours prior to radiotherapy |
Palonosetron 0.5 mg every other day until completion of radiation and at least one hour prior on days of RT
Low or moderately emetogenic radiotherapy will be given to all patients on study.
|
|
Altro: Previous nausea and/or vomiting
Palonosetron 0.5 mg oral capsule given for the length of radiation treatment Previous nausea and/or vomiting 24 hours prior to radiotherapy |
Palonosetron 0.5 mg every other day until completion of radiation and at least one hour prior on days of RT
Low or moderately emetogenic radiotherapy will be given to all patients on study.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Efficacy for prevention of nausea and vomiting events as measured by a daily diary
Lasso di tempo: Day 0 to Day 10 post-radiation
|
Primary outcome is to determine the efficacy of palonosetron for the prevention of radiation-induced vomiting in patients undergoing low or moderate emetogenic radiation therapy.
Daily diary collects events of nausea and/or vomiting, and corresponding severity.
|
Day 0 to Day 10 post-radiation
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Complete prophylaxis of nausea
Lasso di tempo: Day 0 to Day 10 post-radiation
|
Proportion of patients achieving complete prophylaxis of nausea and not requiring the use of any, or supplemental rescue antiemetic medication during and in the 10 days following radiation therapy
|
Day 0 to Day 10 post-radiation
|
|
Complete prophylaxis of vomiting
Lasso di tempo: Day 0 to Day 10 post-radiation
|
Proportion of patients achieving complete prophylaxis of vomiting without requiring the use of any, or supplemental rescue antiemetic medication during and in the 10 days following radiation therapy
|
Day 0 to Day 10 post-radiation
|
|
Partial control of nausea
Lasso di tempo: Day 0 to Day 10 post-radiation
|
Proportion of patients achieving partial control of nausea during and in the 10 days following radiation therapy
|
Day 0 to Day 10 post-radiation
|
|
Partial control of vomiting
Lasso di tempo: Day 0 to Day 10 post-radiation
|
Proportion of patients achieving partial control of vomiting during and in the 10 days following radiation therapy
|
Day 0 to Day 10 post-radiation
|
|
Time to use of rescue medication
Lasso di tempo: Day 0 to Day 10 post-radiation
|
Median time from first fraction of radiation therapy to first use or increase in use of rescue medication
|
Day 0 to Day 10 post-radiation
|
|
Time to nausea
Lasso di tempo: Day 0 to Day 10 post-radiation
|
Median time from first fraction of radiation therapy to first episode or increase in episodes of nausea
|
Day 0 to Day 10 post-radiation
|
|
Time to vomiting
Lasso di tempo: Day 0 to Day 10 post-radiation
|
Median time from first fraction of radiation therapy to first episode or increase in episodes of vomiting
|
Day 0 to Day 10 post-radiation
|
|
Quality of life
Lasso di tempo: Baseline, during the 5th and 10th day of radiation (if applicable), and 3, 5, 7, and 10 days post radiation.
|
Quality of life as measured by the EORTC QLQ-C15-PAL and the FLIE.
|
Baseline, during the 5th and 10th day of radiation (if applicable), and 3, 5, 7, and 10 days post radiation.
|
|
Adverse effects
Lasso di tempo: Day 0 to Day 10 post-radiation
|
The side effects of constipation and headache will be monitored throughout the study period graded according to the CTCAE criteria.
|
Day 0 to Day 10 post-radiation
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Chow Edward, MBBS PhD, Odette Cancer Centre, Sunnybrook Health Sciences Centre
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
- Segni e sintomi, Digestivo
- Nausea
- Vomito
- Effetti fisiologici delle droghe
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Antiemetici
- Agenti gastrointestinali
- Agenti serotoninergici
- Antagonisti della serotonina
- Antagonisti del recettore della serotonina 5-HT3
- Palonosetron
Altri numeri di identificazione dello studio
- Palonosetron
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 .