Clinical trial NCT05281380: VITAMin Insufficiency in Esophagogastric Neoplasms
Official title: Vitamin Insufficiency After Surgery for Esophagogastric Neoplasms: a Prospective Intervention Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Gastric Cancer
Vitamin Disease
Quality of Life
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Micronutrient deficiency yes or no.
timeFrame: 2 years
Secondary outcomes:
measure: The incidence of exocrine pancreatic insufficiency
timeFrame: 2 years
measure: To measure quality of life post-operative
timeFrame: 2 years
Other outcomes:
Locations:
city: Sittard
country: Netherlands
facility: ZuyderlandMC
state: Limburg
Study officials:
affiliation: Zuyderland MC
name: Guy Vijgen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: