Development and Clinical Validation of Ketogen-based Ther... | NCT02964806

Studies
Development and Clinical Validation of Ketogen-based Therapeutic Diet for Pancreaticobiliary Cancer Patients

NCT02964806

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Mar 15, 2018Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Ketogen-based Therapeutic Diet
Pancreaticobiliary Cancer

Interventions

Ordinary Diet
Modified Atkin's Diet
Ketogenic Diet

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 7, 2016Actual

Primary Completion Date

Oct 1, 2017Actual

Completion Date

Oct 1, 2017Actual

First Submitted Date

Nov 13, 2016

First Submission Date that Met QC Criteria

Nov 13, 2016

First Posted Date

Nov 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2018

Last Update Posted Date

Mar 15, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary surgery contribute impaired nutritional status in postoperative period. It can also affect perioperative and oncologic outcomes negatively. Therefore it is important to improve nutritional status in postoperative period by supply tailor-made optimal diets. The investigators have developed customized postoperative diets for pancreaticobiliary cancer patients. The investigators expect that customized diets for pancreaticobiliary patients will increase the food intake rate and contribute a improvement of perioperative outcomes and even oncologic outcomes.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ordinary Diet	Other	Ordinary Diet	Dietary Supplement: Ordinary Diet
Modified Atkin's Diet	Other	Modified Atkin's Diet	Dietary Supplement: Modified Atkin's Diet
Ketogenic Diet	Other	Ketogenic Diet	Dietary Supplement: Ketogenic Diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ordinary Diet	Dietary Supplement		Ordinary Diet
Modified Atkin's Diet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Food Intake Rate(%) for postoperative diet	Diet Intake Rate(%) will be examined by dietary satisfaction questionnaires.	3 days after the diet

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult (age more than 19)
Pancreaticobiliary cancer patient who is scheduled pancreaticoduodenectomy or distal pancreatectomy
Pancreatic cancer / Duodenal cancer / Distal bile duct cancer / Ampulla of Vater cancer

Exclusion Criteria:

Patient who denied clinical trial
Diabetes Mellitus(DM) patient with DM complication
Hyperlipidemia patient with vascular co-morbidity
Impaired renal function or renal failure (GFP<90%)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital		Seoul		120-752	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055423	Diet, Ketogenic

Ancestor Terms

ID	Term
D050528	Diet, Carbohydrate-Restricted
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided