To identify which micronutrient deficiencies are most common after surgery for esophagogastric neoplasms and to observe the effect of supplementation.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is any deficiency (yes/no) defined as any of the below
mentioned vitamins, minerals and proteins.
The main study parameters are measurements of nutrient blood levels measured at
baseline.
and after 6, 12, 24 months supplementation to identify and resolve
deficiencies, including:
- Haemoglobin, haematocrit, MCV
- Vitamins: B1, B6, B11, B12, A, D, E K
- Methylmalonic acid when serum vitamin B12 < 350 pmol/L
- Minerals: serum iron, calcium, zinc, magnesium
- Parathyroid hormone
- Proteins: ferritin/transferrin, Transferrin saturation percentage (TS%)
- Creatinine
- Phosphate
Secondary outcome
The secondary endpoints are:
-Albumin, total protein
-C-reactive protein
-Incidence of micronutrient deficiency post oesophageal or (sub-)total
gastrectomy at baseline
-Occurrence of exocrine pancreatic insufficieny (EPI)
-Occurrence of the following symptoms: diarrhoea, steatorrhea, bloating which
are all associated with EPI
-QoL measured with questionnaires at baseline and after 6 months, 12 months and
24 months of supplementation
-Vitality of patient at baseline and after 6 months, 12 months and 24 months of
supplementation
Background summary
Oesophageal cancer (EC) and gastric cancer (GC) are among the top ten cancers
worldwide, with rapidly increasing incidence and mortality (1, 2). Because of
the invasion of the digestive tract, both diseases have a major impact on the
nutritional status of patients and their quality of life (QoL). In the part of
the population with oesophageal or stomach cancer that is treated with a
curative intent, surgery is the main and most effective treatment for both
diseases. However, anatomical changes after esophagogastric surgery may affect
nutritional intake and absorption in the gastrointestinal tract in several
ways.
Due to the oncologic surgical resection of the oesophagus and/or a significant
part of the stomach the intake and uptake of nutrients is often decreased,
causing malnutrition. Malnutrition is reported in 50-80% of patients with GC or
EC and is associated with a high incidence of morbidity, lower survival rates
and poorer treatment outcomes. For this reason, nutritional status of these
patients has been receiving more attention in clinical research.
Study objective
To identify which micronutrient deficiencies are most common after surgery for
esophagogastric neoplasms and to observe the effect of supplementation.
Study design
multi centre intervention study.
Intervention
Two tailormade supplements for patients; one for that underwent esophagectomy
and one for (sub-)total gastrectomy.
Study burden and risks
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.
Dr. H. van der Hoffplein 1
Sittard-Geleen 6162 BG
NL
Dr. H. van der Hoffplein 1
Sittard-Geleen 6162 BG
NL
Listed location countries
Age
Inclusion criteria
Patients >=18 years of age who underwent an esophagectomy or (sub-)total
gastrectomy for malignancy with no signs of postoperative recurrence of
disease.
Exclusion criteria
- 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, except for vitamin b12
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05281380 |
| CCMO | NL78919.096.21 |