VITAMin Insufficiency in Esophagogastric Neoplasms

NCT05281380 | Unknown DMC

• 1 other identifier: NL78919.096.21
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Micronutrient deficiency yes or no.

  Micronutrient deficiency yes or no.

  2 years

Secondary Outcomes (2)

• The incidence of exocrine pancreatic insufficiency

  2 years

• To measure quality of life post-operative

  2 years

Study Arms (1)

Intervention with vitamin supplement

OTHER

Intervention with vitamin supplement Multi-E and Multi-G

Dietary Supplement: GIKAVI

Interventions

GIKAVI DIETARY_SUPPLEMENT

Two tailormade supplements for patients; one for that underwent esophagectomy and one for (sub-)total gastrectomy.

Intervention with vitamin supplement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

ZuyderlandMC

Sittard, Limburg, 6130MB, Netherlands

RECRUITING

Related Publications (1)

• van der Velden AL, Vermeer TA, Boerma EG, Belgers EH, Stoot JH, Leers MP, Sosef MN, Vijgen GH. Vitamin insufficiency after surgery for oesophagogastric neoplasms: a study protocol for a prospective intervention study. BMJ Open. 2023 Jul 4;13(7):e067981. doi: 10.1136/bmjopen-2022-067981.

  PMID: 37407040 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Guy Vijgen, MD,PhD

  Zuyderland MC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guy Vijgen, MD, PhD

CONTACT

0031884597777; g.vijgen@zuyderland.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: March 16, 2022
• Study Start: December 1, 2021
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)