ZuyderlandMC
Sittard, Limburg, 6130MB, Netherlands
NCT Number: NCT05281380
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Sittard, Limburg, 6130MB, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
A potential subject who meets any of the following criteria will be included for participation in this study:
Exclusion criteria
-
A potential subject who meets any of the following criteria will be excluded from participation in this study:
Two tailormade supplements for patients; one for that underwent esophagectomy and one for (sub-)total gastrectomy.
Time frame: 2 years
Micronutrient deficiency yes or no.
Time frame: 2 years
Faecal elastase test
Time frame: 2 years
Validated quality of life questionnaire
Zuyderland Medisch Centrum
Other
Vitamin Insufficiency After Surgery for Esophagogastric Neoplasms: a Prospective Intervention Study
Acronym: VITAMIN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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