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出境医 / 临床实验 / Preoperative High Protein vs Immunodiet in Surgical Cancer Patients (Preop immuno)
Preoperative High Protein vs Immunodiet in Surgical Cancer Patients (Preop immuno)
Study Description
Brief Summary:
Immunomodulating nutrition is supposed to reduce the number of complications and the legnth of the hospital stay during the postoperative period in patients after major gastrointestinal surgery. The aim of the study is to assess the clinical effect of immunomodulating oral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| General Surgery Cancer of Colon | Drug: IMPACT Drug: resource protein | Phase 4 |
Detailed Description:
Between March 1, 2019, and December 31, 2020, a group of 300 well-nourished patients will be enrolled to the study and randomly assigned two one of two groups: A-high protein oral supplements (ONS) and B- immunomodulating ONS. The study is designed to test the hypothesis that immunonutrition and reduce the incidence of infectious complications after upper gastrointestinal surgery; the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | randomized controlled trial |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Preoperative Use of the High Protein ONS vs Immunoenhancing ONS in Gastrointestinal Cancer Patients Undergoing Surgery |
| Actual Study Start Date : | April 1, 2019 |
| Actual Primary Completion Date : | December 31, 2020 |
| Estimated Study Completion Date : | March 31, 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: High Protein
Provision of 400 ml per day of high protein oral nutritional supplements
|
Drug: resource protein
Administration of oral high-protein oral supplement
|
|
Experimental: Immuno ONS
Provision of 400 ml per day of immunostimulating oral nutritional supplements
|
Drug: IMPACT
Administration of oral immunostimulating oral supplement
|
Outcome Measures
Primary Outcome Measures :
- Infectious complications [ Time Frame: 6 months ]Number and type of infectious complications
Secondary Outcome Measures :
- Surgical complications [ Time Frame: 6 months ]Number and type of surgical complications
- Length of stay [ Time Frame: 14 days ]Hospital length of stay
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- resectable GI cancer
- written consent
Exclusion Criteria:
- inoperable GI cancer
- known allergy to the drug
Contacts and Locations
Contacts
| Contact: Stanislaw Klek, PhD | +48604293566 | klek@poczta.onet.pl | |
| Contact: Eliza Kowalczyk | +48124446526 | eliza.kowalczyk@szpitalskawina.pl |
Locations
| Poland | |
| Stanley Dudrick's Memorial Hospital | Recruiting |
| Skawina, Poland, 32-050 | |
| Contact: Stanislaw Klek, Assoc. Prof. +48604293566 klek@poczta.onet.pl | |
| Principal Investigator: Stanislaw Klek, Assoc. Prof. | |
Sponsors and Collaborators
Stanley Dudrick's Memorial Hospital
Investigators
| Study Director: | Stanislaw Klek | Stanley Dudrick's Memorial Hospital |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 5, 2019 | ||||||||
| First Posted Date ICMJE | June 10, 2019 | ||||||||
| Last Update Posted Date | March 30, 2021 | ||||||||
| Actual Study Start Date ICMJE | April 1, 2019 | ||||||||
| Actual Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Infectious complications [ Time Frame: 6 months ] Number and type of infectious complications
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Preoperative High Protein vs Immunodiet in Surgical Cancer Patients | ||||||||
| Official Title ICMJE | Preoperative Use of the High Protein ONS vs Immunoenhancing ONS in Gastrointestinal Cancer Patients Undergoing Surgery | ||||||||
| Brief Summary | Immunomodulating nutrition is supposed to reduce the number of complications and the legnth of the hospital stay during the postoperative period in patients after major gastrointestinal surgery. The aim of the study is to assess the clinical effect of immunomodulating oral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients. | ||||||||
| Detailed Description | Between March 1, 2019, and December 31, 2020, a group of 300 well-nourished patients will be enrolled to the study and randomly assigned two one of two groups: A-high protein oral supplements (ONS) and B- immunomodulating ONS. The study is designed to test the hypothesis that immunonutrition and reduce the incidence of infectious complications after upper gastrointestinal surgery; the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: randomized controlled trial Masking: None (Open Label)Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
300 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | March 31, 2021 | ||||||||
| Actual Primary Completion Date | December 31, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Poland | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03980704 | ||||||||
| Other Study ID Numbers ICMJE | Imm1 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Stanislaw Klek, Stanley Dudrick's Memorial Hospital | ||||||||
| Study Sponsor ICMJE | Stanley Dudrick's Memorial Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Stanley Dudrick's Memorial Hospital | ||||||||
| Verification Date | March 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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