VITAMin Insufficiency in Esophagogastric Neoplasms | NCT05281380

Studies
VITAMin Insufficiency in Esophagogastric Neoplasms

NCT05281380

Sponsor

Zuyderland Medisch Centrum

Status

Unknown status

Last Update Posted

Jul 27, 2023Actual

Enrollment

248Estimated

Phase

Not Applicable

Conditions

Esophageal Cancer
Gastric Cancer
Vitamin Disease
Quality of Life

Interventions

GIKAVI

Countries

Netherlands

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

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Actual

Primary Completion Date

Nov 1, 2024Estimated

Completion Date

Nov 1, 2024Estimated

First Submitted Date

Oct 21, 2021

First Submission Date that Met QC Criteria

Mar 15, 2022

First Posted Date

Mar 16, 2022Actual

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

Jul 25, 2023

Last Update Posted Date

Jul 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

Rationale: Esophageal cancer and gastric cancer are among the top ten most common cancers worldwide. Both diseases have major impact on the nutritional status of patients and their quality of life. Studies investigating post-operative nutritional status are limited and postoperative identification and treatment of micro- and macronutritional deficiencies are currently lacking in (inter-)national guidelines.

Objective: To identify and target vitamin deficiencies after surgery for esophagogastric neoplasms.

Study design: Single centre intervention study. Study population: Patients aged 18 years and older that underwent esophagectomy or (sub- )total gastrectomy for esophagogastric neoplasms.

Intervention (if applicable): Two tailormade supplements for patients; one for that underwent esophagectomy and one for (sub-)total gastrectomy.

Main study parameters/endpoints: Baseline micronutrient deficiency measurements and after 6, 12, 24 months supplementation,.

Secondary study parameters/ endpoints: Occurrence of exocrine pancreatic insufficiency (n,%), occurrence of diarrhoea (n,%), steatorrhea (n,%), bloating (n,%), time between surgery and start of supplementation (mean in months), quality of life experienced (questionnaires) at baseline and after 6, 12, 24 months supplementation.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In this study, no health-related risks are present for participants due to the administration of supplementation that is already used as in clinical practice.

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

248Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention with vitamin supplement	Other	Intervention with vitamin supplement Multi-E and Multi-G	Dietary Supplement: GIKAVI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GIKAVI	Dietary Supplement	Two tailormade supplements for patients; one for that underwent esophagectomy and one for (sub-)total gastrectomy.	Intervention with vitamin supplement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Micronutrient deficiency yes or no.	Micronutrient deficiency yes or no.	2 years

Secondary Outcomes

Measure	Description	Time Frame
The incidence of exocrine pancreatic insufficiency	Faecal elastase test	2 years
To measure quality of life post-operative	Validated quality of life questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A potential subject who meets any of the following criteria will be included for participation in this study:

Patients ≥18 years of age who underwent an esophagectomy or (sub)total gastrectomy for malignancy with no signs of postoperative recurrence of disease.
Written voluntary informed consent (IC).

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

Patients that underwent a wedge resection of the stomach
Malignant disease recurrence
Metastases
Patients that are not capable to take supplementation due to altered mental status or swallow difficulties
No signed informed consent
Patients who are receiving chemotherapy
Patients with high vitamin status at baseline

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Guy Vijgen, MD, PhD	Contact	0031884597777		g.vijgen@zuyderland.nl

Overall Officials

Name	Affiliation	Role
Guy Vijgen, MD,PhD	Zuyderland MC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ZuyderlandMC	Recruiting	Sittard	Limburg	6130MB	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37407040	Derived	van der Velden AL, Vermeer TA, Boerma EG, Belgers EH, Stoot JH, Leers MP, Sosef MN, Vijgen GH. Vitamin insufficiency after surgery for oesophagogastric neoplasms: a study protocol for a prospective intervention study. BMJ Open. 2023 Jul 4;13(7):e067981. doi: 10.1136/bmjopen-2022-067981.

ID	Term
D004938	Esophageal Neoplasms
D013274	Stomach Neoplasms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms