VITAMin Insufficiency in Esophagogastric Neoplasms (VITAMIN)

Zuyderland Medisch Centrum

Status: Enrolling

Conditions: Vitamin Disease; Gastric Cancer; Esophageal Cancer; Quality of Life

Treatments: Dietary Supplement: GIKAVI

Study type: Interventional

Funder types: Other

Identifiers

NCT05281380

NL78919.096.21

Details and patient eligibility

About

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.

Enrollment: 248 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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248 participants in 1 patient group

Intervention with vitamin supplement

Other group

Description:

Intervention with vitamin supplement Multi-E and Multi-G

Treatment:

Dietary Supplement: GIKAVI