VITAMin Insufficiency in Esophagogastric Neoplasms

Study Overview
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Brief Summary
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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.

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

Conditions
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Esophageal Cancer, Gastric Cancer, Vitamin Disease, Quality of Life

Intervention / Treatment
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* Dietary Supplement: GIKAVI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |