- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04517708
Effectiveness of Nutritional Interventions for Cancer Patients Undergoing Chemotherapy
17. august 2020 opdateret af: Hanoi Medical University
This study aims to estimate the effects of nutritional interventions on the improvement of nutritional status and quality of life (QoL) among gastrointestinal patients in Vietnam
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A quasi-experiment with intervention and control groups for pre- and post-intervention assessment was carried out at the Department of Oncology and Palliative Care - Medical University Hospital from 2016 to 2019.
60 gastrointestinal cancer patients were recruited in each group.
At stage 1, we selected patients of the intervention group who met the inclusion criteria to receive nutritional counseling and diet at the hospital.
At stage 2, we chose patients who were eligible but did not accept the nutritional counseling and diet at the hospital.
Participants in both groups were paired together according to the following criteria: 1) Age group: <40 years old, 40-65 years old and >65 years old; 2) Gender: Male and female; 3) Types of cancer: stomach cancer and colon cancer; 4) Disease stages: stage 1-2 and stage 3-4.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
120
Fase
- Ikke anvendelig
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:
- aged 18 years old or above
- diagnosed with stomach or colon cancer;
- at the initial of receiving chemotherapy treatment;
- indicated for oral feeding;
- not having co-morbidities of chronic diseases such as kidney failure, heart failure, liver failure, diabetes;
- having ability to communicate with data collectors and both attending doctors and agreeing to involve in the study
Exclusion Criteria:
- treated by other methods such as radiation, endocrine, immunity;
- undergoing terminal palliative care;
- having contraindications to oral feeding/enteral nutrition
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Intervention group
Regarding the intervention group, patients were treated with the intervention regimen, which consisted of:
|
Each patient was assigned a specific menu which were prepared by research members during the time of staying at the hospital.
Before discharge, patients were instructed on preparing their diets at home with the recommended amount of energy and protein and given formula milk within two months
|
Ingen indgriben: Control group
Patients had diets based on their demands
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change of nutritional status after 8 weeks
Tidsramme: Baseline and 8 weeks
|
The Scored Patient-Generated Subjective Global Assessment (PG-SGA) was used as the preeminent interdisciplinary patient assessment among patients with oncology.
This tool includes (1) four patient-generated historical components (Weight History, Food Intake, Symptoms, Activities and Function); (2) the professional part (Diagnosis, Metabolic stress, and Physical Exam); (3) the Global Assessment (A = well-nourished, B = moderately malnourished, C = severely malnourished); (4) the total score, and nutritional triage recommendations.
Changes in anthropometric indicators were also reported (weight, MUAC, muscle mass)
|
Baseline and 8 weeks
|
Change of quality of life after 8 weeks: European Organisation for Research and Treatment of Cancer (EORTC) version 3.0
Tidsramme: Baseline and 8 weeks
|
We utilized the European Organisation for Research and Treatment of Cancer (EORTC) version 3.0, which is an integrated and modular approach to holistically evaluate the QoL of patients with cancer.all
dimensions of the tool will range from 0 to 100, in which a higher score presents a better level of functioning/the global health status or a worse level of symptoms.
|
Baseline and 8 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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 (Faktiske)
15. januar 2016
Primær færdiggørelse (Faktiske)
1. juni 2019
Studieafslutning (Faktiske)
15. december 2019
Datoer for studieregistrering
Først indsendt
14. august 2020
Først indsendt, der opfyldte QC-kriterier
17. august 2020
Først opslået (Faktiske)
18. august 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. august 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. august 2020
Sidst verificeret
1. august 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 187/HĐĐĐĐHYHN
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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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