VITAMin Insufficiency in Esophagogastric Neoplasms

Not Applicable

Recruiting

• Conditions: Gastric Cancer; Vitamin Disease; Quality of Life; Esophageal Cancer
• Interventions: Dietary Supplement: GIKAVI

• Registration Number: NCT05281380
• Lead Sponsor: Zuyderland Medisch Centrum

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 available

Study Timeline

• Study First Submitted: 2021-10-21
• Study Start: 2021-12-01
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-16
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 248

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention with vitamin supplement	GIKAVI	Intervention with vitamin supplement Multi-E and Multi-G

Primary Outcome Measures

Name	Time	Method
Micronutrient deficiency yes or no.	2 years	Micronutrient deficiency yes or no.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ZuyderlandMC; 🇳🇱 Sittard, Limburg, Netherlands