- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M4N3M5
- Odette Cancer Centre, Sunnybrook Health Sciences Centre
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: 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.
|
|
Andet: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Efficacy for prevention of nausea and vomiting events as measured by a daily diary
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Complete prophylaxis of nausea
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Chow Edward, MBBS PhD, Odette Cancer Centre, Sunnybrook Health Sciences Centre
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Tegn og symptomer, fordøjelsessystemet
- Kvalme
- Opkastning
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystem
- Antiemetika
- Gastrointestinale midler
- Serotoninmidler
- Serotonin-antagonister
- Serotonin 5-HT3-receptorantagonister
- Palonosetron
Andre undersøgelses-id-numre
- Palonosetron
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