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Prospective Study of Palonosetron in Radiation Induced Nausea and Vomiting (RINV)

5. oktober 2017 opdateret af: Dr. Edward Chow

Prospective Study of Palonosetron in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting (RINV) - a Phase II Study

This phase II study will investigate the use of palonosetron in the efficacy of prophylaxis or rescue of single or multiple fraction radiation induced nausea and vomiting. This prospective study employs a parallel arm design, allowing for inclusion of patients with pre-existing nausea and vomiting versus no current nausea or vomiting. Eligible patients receiving radiotherapy known to have a low or moderate emetogenic risk will receive every other day dosing of 0.5 mg palonosetron for the length of treatment. Nausea, vomiting, use of rescue medication, and impact on quality of life will be monitored during and after radiation treatment completion.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

96

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Ontario
      • Toronto, Ontario, Canada, M4N3M5
        • Odette Cancer Centre, Sunnybrook Health Sciences Centre

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Chow Edward, MBBS PhD, Odette Cancer Centre, Sunnybrook Health Sciences Centre

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2015

Primær færdiggørelse (Faktiske)

7. august 2017

Studieafslutning (Faktiske)

7. august 2017

Datoer for studieregistrering

Først indsendt

20. februar 2015

Først indsendt, der opfyldte QC-kriterier

9. marts 2015

Først opslået (Skøn)

17. marts 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. oktober 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. oktober 2017

Sidst verificeret

1. oktober 2017

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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