VITAMin Insufficiency in Esophagogastric Neoplasms

Quality of Life Clinical Trial

— VITAMIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05281380
• Other study ID #: NL78919.096.21
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: November 1, 2024

Study information

• Verified date: July 2023
• Source: Zuyderland Medisch Centrum
• Contact: Guy Vijgen, MD, PhD
• Phone: 0031884597777
• Email: g.vijgen[@]zuyderland.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Gastric Cancer
• Neoplasms
• Quality of Life

Intervention

Dietary Supplement:
• GIKAVI
Two tailormade supplements for patients; one for that underwent esophagectomy and one for (sub-)total gastrectomy.

Locations

Country	Name	City	State
Netherlands	ZuyderlandMC	Sittard	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Micronutrient deficiency yes or no.	Micronutrient deficiency yes or no.	2 years
Secondary	The incidence of exocrine pancreatic insufficiency	Faecal elastase test	2 years
Secondary	To measure quality of life post-operative	Validated quality of life questionnaire	2 years