- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01876693
A Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy
A Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy in Medical Practice
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Nutritional status is one of the essential factor to determine outcome of chemoradiotherapy in head and neck cancer patients. Almost all these patients develop mucositis during the treatment, which usually leads to treatment interruptions and affects the efficacy of the treatment. Prophylactic gastrostomy has been accepted for these patients with improvement of quality of life. However, there is no prospective study confirming superiority of such treatment.
The investigators enrolled head and neck cancer patients who had the plan of chemoradiotherapy. The patients will be informed about both treatment arms and will decide the arm that they preferred. The treatment interruptions, body weight and nutritional status will be assessed every 2 weeks during treatment period.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Bangkok, Thailand, 10700
- Division of medical oncology, department of medicine Siriraj Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- pathologically confirmed of head and neck cancer
- plan to have chemoradiotherapy session
- Performance status of 0-2
Exclusion Criteria:
- contraindications for percutaneous gastrostomy, eg coagulopathy, obstructed tumor
- Body mass index less than 16 kg/m2
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: control
nutrition counselling with nasogastric tube insertion in the cases of weight loss more than 10% or severe mucositis developed during chemoradiotherapy
|
|
Eksperimentel: prophylactic percutaneous gastrostomy
prophylactic percutaneous gastrostomy with nutrition counselling
|
prophylactic percutaneous gastrostomy with nutrition counselling
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
treatment interruption due to toxicity
Tidsramme: during period of chemoradiatherapy, an expected average of 6 weeks
|
during period of chemoradiatherapy, an expected average of 6 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
quality of life
Tidsramme: during period of chemoradiation, an expected avearage of 6 weeks
|
during period of chemoradiation, an expected avearage of 6 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Suthinee Ithimakin, MD, Faculty of Medicine Siriraj Hospital
Publikationer og nyttige links
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 (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- si041/2013
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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 .
Kliniske forsøg med prophylactic percutaneous gastrostomy
-
Second Affiliated Hospital, School of Medicine,...Zhejiang University; First Affiliated Hospital of Wenzhou Medical University og andre samarbejdspartnereLedigST Elevation MyokardieinfarktKina
-
Shenzhen Core Medical Technology CO.,LTD.Rekruttering
-
London North West Healthcare NHS TrustAfsluttetFistel i AnoDet Forenede Kongerige
-
Pulse Biosciences, Inc.RekrutteringSkjoldbruskkirtel nodule (godartet)Italien
-
ViacorAfsluttetHjertefejl | Mitral regurgitationCanada
-
ViacorDuke University; Medifacts International CorporationSuspenderetHjertefejl | Mitral regurgitationBelgien, Tjekkiet, Tyskland, Holland, Schweiz
-
Mitralign, Inc.UkendtHjerteklapsygdom | Trikuspidalventilinsufficiens | Kronisk symptomatisk funktionel trikuspidal regurgitationForenede Stater
-
Mitralign, Inc.CardioVascular Research Foundation, Korea; Regulatory and Clinical Research... og andre samarbejdspartnereUkendtSikkerhed og ydeevne af Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) (SCOUT-II)Hjerteklapsygdom | Trikuspidalventilinsufficiens | Kronisk symptomatisk funktionel trikuspidal regurgitationItalien, Holland, Tyskland, Portugal
-
Medtronic Spinal and BiologicsAfsluttetSpinal stenoseTyskland, Belgien, Det Forenede Kongerige
-
Abbott Medical DevicesAfsluttetMitralklapprolapsDet Forenede Kongerige