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Effect of oral nutritional supplements on outcomes of colorectal cancer surgery: Randomized controlled trial and microbiome analysis

Status Approved

First Submitted Date

2019/04/08
Registered Date

2019/04/15
Last Updated Date

2019/12/16

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0003770
Unique Protocol ID	ONS-CRS
Public/Brief Title	Effect of oral nutritional supplements on outcomes of colorectal cancer surgery
Scientific Title	Effect of oral nutritional supplements on outcomes of colorectal cancer surgery: Randomized controlled trial and microbiome analysis
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	CNUHH-2019-062
Approval Date	2019-04-03
Institutional Review Board Name	Institutional Review Board, Chonnam National University Hwasun Hospital
Institutional Review Board Address	322 Seoyang-ro Hwasun-eup, Hwasun Jeonnam, Korea
Institutional Review Board Telephone	061-379-7598
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Soo Young Lee
Title	Assistant professor
Telephone	+82-61-379-7678
Affiliation	Chonnam National University Hospital Hwasun Hospital
Address	322 Seoyang-ro Hwasun-eup, Hwasun Jeonnam, Korea
Contact Person for Public Queries
Name	Soo Young Lee
Title	Assistant professor
Telephone	+82-61-379-7678
Affiliation	Chonnam National University Hospital Hwasun Hospital
Address	322 Seoyang-ro Hwasun-eup, Hwasun Jeonnam, Korea
Contact Person for Updating Information
Name	Soo Young Lee
Title	Assistant professor
Telephone	+82-61-379-7678
Affiliation	Chonnam National University Hospital Hwasun Hospital
Address	322 Seoyang-ro Hwasun-eup, Hwasun Jeonnam, Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2019-04-17 Actual
Target Number of Participant	176
Primary Completion Date
Study Completion Date
Name of Study	Chonnam National University Hospital Hwasun Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2019-04-17 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Chonnam National University Hospital Hwasun Hospital
Organization Type	Medical Institute
Project ID	HCRI19014

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Chonnam National University Hospital Hwasun Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	□ Background ○ Incidence of colorectal cancer - Age-standardized incidence rate in Korea : 31.9 / 100,000 - 3rd most common cancer in Korea ○ Treatment of colorectal cancer - Radical surgery is the most important treatment - The occurrence of postoperative complication is every surgeon's concern ○ Postoperative complication - Infectious compication: the majority of postoperative complication --> upto 30% of postoperative complication ○ Nutritional status and postoperative complication - Higher prevalence of malnutrition in cancer patients (26-76%) - Malnutrition may be related to postoperative complicatio - Although current guidelines recommend oral nutritional supplements preoperatively, the current evidence of the relationship between preoperative nutritional support and postoperative complication is still lacking □ Purpose ○ To consolidate the evidence of preoperative nutritional support - To evaluate the effect of oral nutritional supplements on outcomes of colorectal cancer surgery - To evaluate the effect of oral nutritional supplements on microbiome, which investigates theoretical basis of nutritional support □ Effect ○ To establish preoperative nutritional treatment protocol ○ To decrease postoperative complication in colorectal cancer surgery

Study Summary Information

Lay Summary

□ Background
  ○ Incidence of colorectal cancer
    - Age-standardized incidence rate in Korea : 31.9 / 100,000
    - 3rd most common cancer in Korea
  ○ Treatment of colorectal cancer
    - Radical surgery is the most important treatment
    - The occurrence of postoperative complication is every surgeon&#39;s concern
  ○ Postoperative complication
    - Infectious compication: the majority of postoperative complication
    --&gt; upto 30&#37; of postoperative complication
  ○ Nutritional status and postoperative complication
    - Higher prevalence of malnutrition in cancer patients (26-76&#37;)
    - Malnutrition may be related to postoperative complicatio
    - Although current guidelines recommend oral nutritional supplements preoperatively, the current evidence of the relationship between preoperative nutritional support and postoperative complication is still lacking

□ Purpose
  ○ To consolidate the evidence of preoperative nutritional support 
    - To evaluate the effect of oral nutritional supplements on outcomes of colorectal cancer surgery
    - To evaluate the effect of oral nutritional supplements on microbiome, which investigates theoretical basis of nutritional support 

□ Effect
  ○ To establish preoperative nutritional treatment protocol
  ○ To decrease postoperative complication in colorectal cancer surgery

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Phase3
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Dietary Supplement
Intervention Description	○ Oral nutritional supplement - Newcare Omega (Daesang Wellife) : Constituents (%) - Protein:Lipid:Carbohydrate = 18:27:55 : arginine 0.25% 500mg, fish oil 0.25% (DHA+EPA 18%) 70mg, Protein 9g ○ 2 packs per day, for 7 days (based on previous studies) : 9 days before surgery ~ 3 days before surgery * Contrast drug; N/A ** If CNUHH-NRST ≥4, preoperative nutritional counseling by NST team should be encouraged
Number of Arms	2
Arm 1	Arm Label ONS
	Target Number of Participant 88
	Arm Type Experimental
	Arm Description ○ Oral nutritional supplement - Newcare Omega (Daesang Wellife) : Constituents (%) - Protein:Lipid:Carbohydrate = 18:27:55 : arginine 0.25% 500mg, fish oil 0.25% (DHA+EPA 18%) 70mg, Protein 9g ○ 2 packs per day, for 7 days (based on previous studies) : 9 days before surgery ~ 3 days before surgery
Arm 2	Arm Label Comparison group
	Target Number of Participant 88
	Arm Type Active comparator
	Arm Description Routine nutritional risk screening and nutritional counseling (If CNUHH-NRST ≥4, preoperative nutritional counseling by NST team should be encouraged)

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (C18.9)Malignant neoplasm of colon, unspecified Colorectal cancer
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~80Year
	Description Primary colorectal cancer (age 20-80 years)
Exclusion Criteria	obstruction, perforation (when emergency surgery is needed) patients who cannot eat pregnancy CNUHH-NRST >= 6
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Infectious complication rate
Timepoint	30 days after surgery
Secondary Outcome(s) 1
Outcome	change of microbiome
Timepoint	1 week after surgery

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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