NCT05281380Completed
VITAMin Insufficiency in Esophagogastric Neoplasms
Vitamin Insufficiency After Surgery for Esophagogastric Neoplasms: a Prospective Intervention Study
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 107 (actual)
- First submitted
- 21 Oct 2021
- Start date
- 1 Dec 2021
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Zuyderland Medisch Centrum
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05281380
What you commit to
- Study type: Interventional
- Participants enrolled: 107
- From 1 Dec 2021 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients that underwent a wedge resection of the stomach
- Patients who are receiving chemotherapy
Other illness
- Malignant disease recurrence
Other
- \-
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Metastases
- Patients that are not capable to take supplementation due to altered mental status or swallow difficulties
- No signed informed consent
- Patients with high vitamin status at baseline
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ZuyderlandMC Coordinator of this site? Confirm its status | Sittard | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.