Nutrition in Gastrointestinal Tumors (NutriGIT)

Analysis of Nutritional Status in Patients With Malignant Tumor Diseases of the Gastrointestinal Tract

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer; Pancreatic Cancer; Small Intestine Cancer; Rectal Cancer; Neuroendocrine Tumors; Bile Duct Cancer; Colon Cancer; Liver Cancer; Oesophageal Cancer; GIST, Malignant
• Intervention / Treatment: Other: No intervention - observational study only

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.

• Study Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

• Study Contact: Name: Ali A Aghdassi, Professor; Phone Number: +493834867230; Email: ali.aghdassi@med-uni-greifswald.de

Study Locations

• Germany
  • Greifswald, Germany, 17475
    • University Medicine Greifswald

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Initial Diagnosis; Patients with initial diagnosis of a malignant condition of the gastrointestinal tract planned to receive cytostatic treatment.	Other: No intervention - observational study only; No intervention - observational study only
Ongoing Cytostatic Treatment; Patients with a malignant condition of the gastrointestinal tract already receiving cytostatic treatment.	Other: No intervention - observational study only; No intervention - observational study only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Malnutrition According to the Global Leadership Initiative on Malnutrition criteria (GLIM criteria)	Change in prevalence of malnutrition according to the GLIM criteria	3 months after study enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Malnutrition According to the European Society for Clinical Nutrition and Metabolism criteria (ESPEN criteria)	Change in prevalence of malnutrition according to the ESPEN criteria	3 months after study enrollment
Skeletal Muscle Mass	Changes in the skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA)	3 months after study enrollment
Fat Free Mass	Changes in the fat free mass measured by Bioelectrical Impedance Analysis (BIA)	3 months after study enrollment
Fat Mass	Changes in the fat mass measured by Bioelectrical Impedance Analysis (BIA)	3 months after study enrollment
Total Body Water	Changes in the total Body water measured by Bioelectrical Impedance Analysis (BIA)	3 months after study enrollment
Extracellular Water	Changes in the total extracellular water measured by Bioelectrical Impedance Analysis (BIA)	3 months after study enrollment
Phase Angle	Changes in the phase angle measured by Bioelectrical Impedance Analysis (BIA)	3 months after study enrollment
Body Weight	Changes in body weight measured in kilograms	3 months after study enrollment
Height	Changes in height measured in meters	3 months after study enrollment
Body Mass Index	Changes in body mass index in kg/m^2 (calculated from the values obtained for body weight and height)	3 months after study enrollment
Waist Circumference	Changes in waist circumference measured in centimeters	3 months after study enrollment
Hip Circumference	Changes in hip circumference measured in centimeters	3 months after study enrollment
Waist-to-Hip Ratio	Changes in waist-to-hip ratio (calculated from the values obtained for waist and hip circumference)	3 months after study enrollment
Upper Arm Circumference	Changes in upper arm circumference measured in centimeters	3 months after study enrollment
Triceps Skinfold Thickness	Changes in triceps skinfold thickness measured in millimeters	3 months after study enrollment
Muscle Strength	Changes in muscle strength measured by a handgrip strength dynamometer	3 months after study enrollment
Muscle Function	Changes in muscle function measured by a 4-m gait speed test	3 months after study enrollment
Sarcopenia According to the European Working Group on Sarcopenia in Older People 2 criteria (EWGSOP2 criteria)	Change in prevalence of sarcopenia according to the EWGSOP2 criteria	3 months after study enrollment
Energy Intake	Changes in energy intake assessed by 3-day weighed dietary record	3 months after study enrollment
Protein Intake	Changes in protein intake (in g/day) assessed by 3-day weighed dietary record	3 months after study enrollment
Carbohydrate Intake	Changes in carbohydrate intake (in g/day) assessed by 3-day weighed dietary record	3 months after study enrollment
Fat Intake	Changes in fat intake (in g/day) assessed by 3-day weighed dietary record	3 months after study enrollment
Dietary Fiber Intake	Changes in dietary fiber intake (in g/day) assessed by 3-day weighed dietary record	3 months after study enrollment
Physical Activity	Changes in metabolic equivalent of task per day and activity level are assessed by employment of the German version of the International Physical Activity Questionnaire (IPAQ) Short Form	3 months after study enrollment
Complete Blood Count	Changes in complete blood count	3 months after study enrollment
Albumin	Changes in plasma concentration of albumin	3 months after study enrollment
Aspartate Transaminase	Changes in plasma concentration of aspartate transferase	3 months after study enrollment
Alanine Aminotransferase	Changes in plasma concentration of alanine aminotransferase	3 months after study enrollment
Gamma-glutamyl Transferase	Changes in plasma concentration of gamma-glutamyl transferase	3 months after study enrollment
Bilirubin	Changes in plasma concentration of bilirubin	3 months after study enrollment
Creatinine	Changes in plasma concentration of creatinine	3 months after study enrollment
Urea	Changes in plasma concentration of urea	3 months after study enrollment
C-reactive Protein	Changes in plasma concentration of C-reactive protein	3 months after study enrollment
Plasma Metabolome	Changes in plasma metabolome	3 months after study enrollment
Plasma Transcriptome	Changes in plasma transcriptome	3 months after study enrollment
Intestinal Microbiome	Changes in intestinal microbiome	3 months after study enrollment

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Investigators: Principal Investigator: Ali A Aghdassi, Professor, University Medicine Greifswald

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2020
• Primary Completion (Actual): December 6, 2022
• Study Completion (Actual): December 6, 2022

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 22, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Intestinal Diseases; Biliary Tract Diseases; Bile Duct Diseases; Biliary Tract Neoplasms; Cholangiocarcinoma; Neuroendocrine Tumors; Intestinal Neoplasms; Bile Duct Neoplasms
• Other Study ID Numbers: BB 071/20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No