VITAMin Insufficiency in Esophagogastric Neoplasms (VITAMIN)

Vitamin Insufficiency After Surgery for Esophagogastric Neoplasms: a Prospective Intervention Study

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Gastric Cancer; Esophageal Cancer; Vitamin Disease
• Intervention / Treatment: Dietary supplement: GIKAVI

• Study Type: Interventional
• Enrollment (Estimated): 248
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guy Vijgen, MD, PhD; Phone Number: 0031884597777; Email: g.vijgen@zuyderland.nl

Study Locations

• Netherlands
  • Limburg
    • Sittard, Limburg, Netherlands, 6130MB
      • Recruiting
      • ZuyderlandMC
      • Contact: Guy Vijgen, MD, PhD; Phone Number: 0031618942736; Email: g.vijgen@zuyderland.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intervention with vitamin supplement; Intervention with vitamin supplement Multi-E and Multi-G	Dietary supplement: GIKAVI; Two tailormade supplements for patients; one for that underwent esophagectomy and one for (sub-)total gastrectomy.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	2 years

Collaborators and Investigators

• Sponsor: Zuyderland Medisch Centrum
• Investigators: Principal Investigator: Guy Vijgen, MD,PhD, Zuyderland MC

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: NL78919.096.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No