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Preoperative Nutritional Support in Malnutritional Cancer Patients

7. juni 2018 opdateret af: Sang-Jae Park, National Cancer Center, Korea

Prospective Study of Preoperative Nutritional Support in Malnutritional Pancreatobiliary Cancer Patients

Malnutrition patients are known to have more postoperative complications and mortality. And most of hepatobiliary-pancreatic cancer surgeries accompany high postoperative morbidity and mortality rate. Therefore for the malnourished patients anticipating major surgery, preoperative nutritional support is recommended according to the ASPEN (American society of parenteral and enteral nutrition) and ESPEN (European society of parenteral and enteral nutrition) guideline. However there is no prospective trial to prove the clinical impact of preoperative nutritional support for malnourished patients.

The purpose of this study is to evaluate the clinical impact of preoperative nutritional support for malnourished cancer patients anticipating HBP surgery. Primary objective is to compare the complication rate and secondary object is to compare the quality of life, hospital stay and cost.

Studieoversigt

Detaljeret beskrivelse

This is single arm study with historical comparison. The historical control group did not receiving nutritional support. In previous results show that about 25% complication rates. Complication rates are expected in the group receiving nutritional support is less than 10 % ( previous studies (NCCNCS-11-460)).

For support group, preoperative nutritional support is given for 5 or more days preoperatively by nutritional support program. Nutritional support program is briefly described below.

Interval: 5-10 days Contents: admission is required

  • Calories: 30-35Kg, via enteral or parenteral
  • Protein: 1.2-1.5g/Kg
  • Lipid : 1-1.5g/Kg
  • Mineral and vitamins supply
  • Blood glucose control
  • Daily monitoring by dietician and specialized nurse

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republikken, 410-769
        • National Cancer Center

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

20 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Subjects in anticipating major surgery of hepatobiliary pancreatic cancer
  2. Patients diagnosed with malnutrition (at least more than one)

    1. PG-SGA B or C
    2. Weight loss >10% within 6 month
    3. BMI <18.5
    4. Serum Albumin <3.0
  3. Age less than 80 years old over 20 years old
  4. Performance status (ECOG scale): 0-1
  5. Adequate organ functions

    1. Hb ≥7.0 g/dl
    2. ANC ≥1,500/mm3
    3. PLT ≥80,000/mm3
    4. Liver function: AST/ALT ≤5×upper limit of normal
    5. Creatinine ≤2.0 ULN

Exclusion Criteria:

  1. Biopsy, drainage tube insertion, and other minor surgery
  2. palliative surgery
  3. Serious illness or medical conditions, as follows;

    1. congestive heart failure (NYHA class III or IV)
    2. unstable angina or myocardial infarction within the past 6 months,
    3. significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
    4. uncontrolled hypertension
    5. hepatic cirrhosis( ≥ Child class B)
    6. interstitial pneumonia, pulmonary adenomatosis
    7. psychiatric disorder that may interfere with and/or protocol compliance
    8. unstable diabetes mellitus
    9. uncontrolled ascites or pleural effusion
    10. active infection
  4. Pregnancy
  5. Any patients judged by the investigator to be unfit to participate in the study

Studieplan

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

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
Eksperimentel: nutritional support program apply
Preoperative nutritional support program is given for 5 or more days preoperatively by nutritional support program.

Nutritional support program is briefly described below.

Interval: 5-10 days Contents: admission is required

  • Calories: 30-35Kg, via enteral or parenteral
  • Protein: 1.2-1.5g/Kg
  • Lipid : 1-1.5g/Kg
  • Mineral and vitamins supply
  • Blood glucose control
  • Daily monitoring by dietician and specialized nurse
Ingen indgriben: historical control group
Historical control group is that did not receiving

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
postoperative complication
Tidsramme: at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)
expected the duration of hospital stay of postoperation is 4~6 weeks.
at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
postoperative hospital stay
Tidsramme: expected the duration of hospital stay of postoperation is 4~6 weeks.
expected the duration of hospital stay of postoperation is 4~6 weeks.
expected the duration of hospital stay of postoperation is 4~6 weeks.
quality of life
Tidsramme: preoperative, postoperative 14days
preoperative, postoperative 14days
preoperative, postoperative 14days
postoperative cost( + nutritional support cost)
Tidsramme: at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)
expected the duration of hospital stay of postoperation is 4~6 weeks.
at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
immunologic change(CD4/CD8) after nutritional support
Tidsramme: preoperative, postoperative 14days
CD4/CD8, immunoglobulin G, M, A
preoperative, postoperative 14days

Samarbejdspartnere og efterforskere

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

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: SangJae Park, National Cancer Center, Korea

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. oktober 2013

Primær færdiggørelse (Faktiske)

27. november 2013

Studieafslutning (Faktiske)

5. april 2017

Datoer for studieregistrering

Først indsendt

8. juni 2015

Først indsendt, der opfyldte QC-kriterier

7. december 2015

Først opslået (Skøn)

10. december 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juni 2018

Sidst verificeret

1. juni 2018

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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