Clinical trial NCT04476082: Nutrition in Gastrointestinal Tumors
Official title: Analysis of Nutritional Status in Patients With Malignant Tumor Diseases of the Gastrointestinal Tract
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Oesophageal Cancer
Colon Cancer
Liver Cancer
Rectal Cancer
Bile Duct Cancer
GIST, Malignant
Neuroendocrine Tumors
Small Intestine Cancer
Gastric Cancer
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited at University Medicine Greifswald (Northeast Germany). Patients with initial diagnosis of a malignant condition of the gastrointestinal tract planned to receive cytostatic treatment will be identified in the gastrointestinal ward of the hosptial. Recruitment of patients receiving cytostatic treatment of a known malignant condition of the gastrointestinal tract will take place in the hospital's cancer day unit.

Brief summary: Malnutrition and loss of muscle mass frequently occur in patients undergoing chemotherapy and can negatively effect therapy outcome. Especially patients with cancer of the gastrointestinal tract are often affected by malnutrition. Therefore, this study aims to examine changes in nutritional status of patients with cancer of the gastrointestinal tract during chemotherapy. Findings of this study will help to improve nutritional treatment of patients undergoing chemotherapy.

Detailed description: Malnutrition and sarcopenia are common complications in patients with malignant diseases of the gastrointestinal tract. During chemotherapy there is a high risk of further impairment of nutritional status due to anorexia, nausea, emesis and other gastrointestinal conditions that adversely impact food assimilation or absorption. Findings on changes of nutritional status during chemotherapy are scarce but of paramount importance for adequate nutrition therapy. Therefore, this study aims to provide a detailed description of changes in nutritional status of patients with a malignant condition of the gastrointestinal tract during chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Patients with initial diagnosis of a malignant condition of the gastrointestinal tract planned to receive cytostatic treatment.
* ongoing cytostatic treatment of a known malignant condition of the gastrointestinal tract

Exclusion Criteria:

* pregnancy
* history of any other malignant tumor disease
* inability to provide consent

Primary outcomes:
measure: Prevalence of Malnutrition According to the Global Leadership Initiative on Malnutrition criteria (GLIM criteria)
timeFrame: 3 months after study enrollment
Secondary outcomes:
measure: Prevalence of Malnutrition According to the European Society for Clinical Nutrition and Metabolism criteria (ESPEN criteria)
timeFrame: 3 months after study enrollment
measure: Skeletal Muscle Mass
timeFrame: 3 months after study enrollment
measure: Fat Free Mass
timeFrame: 3 months after study enrollment
measure: Fat Mass
timeFrame: 3 months after study enrollment
measure: Total Body Water
timeFrame: 3 months after study enrollment
measure: Extracellular Water
timeFrame: 3 months after study enrollment
measure: Phase Angle
timeFrame: 3 months after study enrollment
measure: Body Weight
timeFrame: 3 months after study enrollment
measure: Height
timeFrame: 3 months after study enrollment
measure: Body Mass Index
timeFrame: 3 months after study enrollment
measure: Waist Circumference
timeFrame: 3 months after study enrollment
measure: Hip Circumference
timeFrame: 3 months after study enrollment
measure: Waist-to-Hip Ratio
timeFrame: 3 months after study enrollment
measure: Upper Arm Circumference
timeFrame: 3 months after study enrollment
measure: Triceps Skinfold Thickness
timeFrame: 3 months after study enrollment
measure: Muscle Strength
timeFrame: 3 months after study enrollment
measure: Muscle Function
timeFrame: 3 months after study enrollment
measure: Sarcopenia According to the European Working Group on Sarcopenia in Older People 2 criteria (EWGSOP2 criteria)
timeFrame: 3 months after study enrollment
measure: Energy Intake
timeFrame: 3 months after study enrollment
measure: Protein Intake
timeFrame: 3 months after study enrollment
measure: Carbohydrate Intake
timeFrame: 3 months after study enrollment
measure: Fat Intake
timeFrame: 3 months after study enrollment
measure: Dietary Fiber Intake
timeFrame: 3 months after study enrollment
measure: Physical Activity
timeFrame: 3 months after study enrollment
measure: Complete Blood Count
timeFrame: 3 months after study enrollment
measure: Albumin
timeFrame: 3 months after study enrollment
measure: Aspartate Transaminase
timeFrame: 3 months after study enrollment
measure: Alanine Aminotransferase
timeFrame: 3 months after study enrollment
measure: Gamma-glutamyl Transferase
timeFrame: 3 months after study enrollment
measure: Bilirubin
timeFrame: 3 months after study enrollment
measure: Creatinine
timeFrame: 3 months after study enrollment
measure: Urea
timeFrame: 3 months after study enrollment
measure: C-reactive Protein
timeFrame: 3 months after study enrollment
measure: Plasma Metabolome
timeFrame: 3 months after study enrollment
measure: Plasma Transcriptome
timeFrame: 3 months after study enrollment
measure: Intestinal Microbiome
timeFrame: 3 months after study enrollment
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald
Study officials:
affiliation: University Medicine Greifswald
name: Ali A Aghdassi, Professor
role: PRINCIPAL_INVESTIGATOR
References: