VITAMIN: VITAMin Insufficiency in Esophagogastric Neoplasms

Sponsor
Zuyderland Medisch Centrum (Other)
Overall Status
Recruiting
CT.gov ID
NCT05281380
Collaborator
(none)
248
1
1
35
7.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: GIKAVI
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
248 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Vitamin Insufficiency After Surgery for Esophagogastric Neoplasms: a Prospective Intervention Study
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Micronutrient deficiency yes or no. [2 years]

    Micronutrient deficiency yes or no.

Secondary Outcome Measures

  1. The incidence of exocrine pancreatic insufficiency [2 years]

    Faecal elastase test

  2. To measure quality of life post-operative [2 years]

    Validated quality of life questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ZuyderlandMC Sittard Limburg Netherlands 6130MB

Sponsors and Collaborators

  • Zuyderland Medisch Centrum

Investigators

  • Principal Investigator: Guy Vijgen, MD,PhD, Zuyderland MC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zuyderland Medisch Centrum
ClinicalTrials.gov Identifier:
NCT05281380
Other Study ID Numbers:
  • NL78919.096.21
First Posted:
Mar 16, 2022
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2022