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Application of Whole-course Standardized Nutrition Management During Peri-radiotherapy in Patients With Nasopharyngeal Carcinoma After Radiotherapy: a Multicenter Randomized Controlled Clinical Study

14. august 2021 oppdatert av: Yun-fei Xia, Sun Yat-sen University
This study will present an advanced equipment of tumor nutrition diagnosis and assesment for nasopharyngeal cancer(NPC) radiotherapy patients in nutritional risk screening, evaluation, diagnosis and directing nutritional intervention, aiming to explore the advantages of the whole nutritional management in acute radiation reaction rate, completion rate of radiotherapy, nutritional status, and quality of life for NPC patients.

Studieoversikt

Detaljert beskrivelse

In this study, nutrition intervention was performed in one group of nasopharyngeal carcinoma patients with no nutritional risk during the periperiod of radiotherapy , and the other group with no additional intervention when without nutritional risks, for evaluating the value of overall nutritional management in the periperiod radiotherapy.

Studietype

Intervensjonell

Registrering (Forventet)

388

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Guangzhou
      • Guangdong, Guangzhou, Kina, 510000
        • Rekruttering
        • Sun Yat-sen University Cancer Center
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with nasopharyngeal carcinoma confirmed by histopathology
  • Newly diagnosed patients without distant metastasis
  • Age >18
  • KPS ≥ 70
  • Nasopharyngeal radiotherapy alone or concurrent chemoradiotherapy was planned to be received, andIMRT was used for radiotherapy
  • The patient's blood counts,the lung, liver and renal functions were tolerant to radiotherapy/chemoradiotherapy( WBC ≥ 4.0*109/L, NE ≥ 2.0*109/L, PLT 100*109/L and Hb≥ 10g/L. AST and ALT ≤ 2.5 *the upper limit(UL) ,TBIL≤1.2*the UL, CRE≤1.2* the UL, and ALP≤5* the UL). And the ECG should be normal
  • Good nutritional status,BMI:18~23Kg/ m2, PG-SGA ≤1,NRS 2002<3score
  • No other previous neoplastic diseases, except for cured cervical carcinoma in situ skin basal carcinoma
  • No serious gastrointestinal diseases (moderate and severe duodenal and gastric ulcer, ulcerative colitis, Crohn's disease, etc.)
  • No AIDS and no diabetes
  • Clear mind, no communication barriers, able to answer questions
  • Voluntarily participate and sign the informed consent in person.

Exclusion Criteria:

  • Patients with gastrointestinal dysfunction, intestinal obstruction, pyloric obstruction, Acute gastrointestinal bleeding
  • Patients who are allergic to nutritional therapy or have severe allergic constitution
  • Uncontrolled systemic diseases, such as severe liver disease (such as cirrhosis), kidney disease, respiratory diseases and so on.
  • Women who are pregnant or breastfeeding or no contraception and women with positive pregnancy test before receiving treatment
  • Special dietary requirements: such as no having a certain food or a vegetarian.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention group
The recommended target energy for NPC radiotherapy patients is 25-30kcal/(kg·d), in addition,the intervention group begins with an additional 50% daily energy increase during the peri-radiotherapy.
The target energy of radiotherapy patients is recommended to be 25-30kcal/(kg·d), and the target energy of the intervention group should be increased by an additional 50% daily from the beginning of radiotherapy. Specifically, under the condition of ensuring the daily target energy 14kcal/(kg·d), formula nutrition should be added daily.
Ingen inngripen: Conventional group
Unlike the intervention group,conventional group should be treated according to the consensus of experts on standardized nutrition management.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of acute radiation reactions
Tidsramme: 12 months
This study mainly includes oral mucosa mucositis, salivary glands injury induced by radiotherapy, laryngoesophageal mucositis referring to The 2020 Expert Consensus on the Standardized Management of Radiation Oncology for nutrition-related radiation injury responses.
12 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of decline in nutritional status
Tidsramme: 12 months
analysis by the clinical nutrition detection analyzer
12 months
Incidence of decline in quality of life scores(QOL)
Tidsramme: 12 months
It is measured by a standard QOL table,including 12 questions.Each question is 5 points,so there are 60 points and 5 grades(51-60 points, 41-50 points, 31-40 points, 21-30 points,<20 points).A higher score is a better life.
12 months
Self-rating Anxiety screening Scale(GAD-7)
Tidsramme: 12 months
A GAD-7 table would estimate one's anxiety according to the emotion of the past two weeks,including 9 questions and 27 points totally.There are 4 grades of anxiety, a LOWER score means a normal mind state. Actually,0-4 points is/are no anxiety.5-9 points represent slight anxiety .10-14 are in moderate anxiety.15-27 are severe anxiety,respectively.
12 months
Self-rating Scale for Depression Screening (PHQ-9)
Tidsramme: 12 months
A PHQ-9 table is a simplified Scale for Depression Screening,it would estimate one's depression emotion according to the mind of the past two weeks,including 9 questions and 27 points totally.There are 4 grades of depression, a LOWER score is equal to a GOOD mind.Actually,0-4 points is/are no depression.5-9 are depressed but not obvious.10-14 are in obvious depression.15-27 are severe depression,respectively.
12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Yunfei Xia, MD, Sun Yat-sen University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

26. april 2021

Primær fullføring (Forventet)

26. april 2022

Studiet fullført (Forventet)

26. april 2022

Datoer for studieregistrering

Først innsendt

3. august 2021

Først innsendt som oppfylte QC-kriteriene

14. august 2021

Først lagt ut (Faktiske)

17. august 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. august 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. august 2021

Sist bekreftet

1. august 2021

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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