- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02626195
Preoperative Nutritional Support in Malnutritional Cancer Patients
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, Corea, Repubblica di, 410-769
- National Cancer Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Subjects in anticipating major surgery of hepatobiliary pancreatic cancer
Patients diagnosed with malnutrition (at least more than one)
- PG-SGA B or C
- Weight loss >10% within 6 month
- BMI <18.5
- Serum Albumin <3.0
- Age less than 80 years old over 20 years old
- Performance status (ECOG scale): 0-1
Adequate organ functions
- Hb ≥7.0 g/dl
- ANC ≥1,500/mm3
- PLT ≥80,000/mm3
- Liver function: AST/ALT ≤5×upper limit of normal
- Creatinine ≤2.0 ULN
Exclusion Criteria:
- Biopsy, drainage tube insertion, and other minor surgery
- palliative surgery
Serious illness or medical conditions, as follows;
- congestive heart failure (NYHA class III or IV)
- unstable angina or myocardial infarction within the past 6 months,
- significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
- uncontrolled hypertension
- hepatic cirrhosis( ≥ Child class B)
- interstitial pneumonia, pulmonary adenomatosis
- psychiatric disorder that may interfere with and/or protocol compliance
- unstable diabetes mellitus
- uncontrolled ascites or pleural effusion
- active infection
- Pregnancy
- Any patients judged by the investigator to be unfit to participate in the study
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
|
|
Nessun intervento: historical control group
Historical control group is that did not receiving
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
postoperative complication
Lasso di tempo: 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.)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
postoperative hospital stay
Lasso di tempo: 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
Lasso di tempo: preoperative, postoperative 14days
|
preoperative, postoperative 14days
|
preoperative, postoperative 14days
|
|
postoperative cost( + nutritional support cost)
Lasso di tempo: 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.)
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
immunologic change(CD4/CD8) after nutritional support
Lasso di tempo: preoperative, postoperative 14days
|
CD4/CD8, immunoglobulin G, M, A
|
preoperative, postoperative 14days
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: SangJae Park, National Cancer Center, Korea
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NCCCTS-13-676
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