NCT05281380

VITAMin Insufficiency in Esophagogastric Neoplasms

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: Zuyderland Medisch Centrum · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Cancer
• Gastric Cancer
• Vitamin Disease
• Quality of Life

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	GIKAVI	Two tailormade supplements for patients; one for that underwent esophagectomy and one for (sub-)total gastrectomy.

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2022-03-16
• Last updated: 2023-07-27

Locations

1 site across 1 country: Netherlands