- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
Ontario
-
Toronto, Ontario, Kanada, M4N3M5
- Odette Cancer Centre, Sunnybrook Health Sciences Centre
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Sonstiges: 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.
|
|
Sonstiges: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Efficacy for prevention of nausea and vomiting events as measured by a daily diary
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Complete prophylaxis of nausea
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Chow Edward, MBBS PhD, Odette Cancer Centre, Sunnybrook Health Sciences Centre
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Anzeichen und Symptome, Verdauungstrakt
- Brechreiz
- Erbrechen
- Physiologische Wirkungen von Arzneimitteln
- Neurotransmitter-Agenten
- Molekulare Mechanismen der pharmakologischen Wirkung
- Autonome Agenten
- Agenten des peripheren Nervensystems
- Antiemetika
- Magen-Darm-Mittel
- Serotonin-Agenten
- Serotonin-Antagonisten
- Serotonin-5-HT3-Rezeptorantagonisten
- Palonosetron
Andere Studien-ID-Nummern
- Palonosetron
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