Nutrition in Gastrointestinal Tumors

Completed

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

• Registration Number: NCT04476082
• Lead Sponsor: University Medicine Greifswald

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.

Study Timeline

• Study Start: 2020-06-25
• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-17
• Primary Completion: 2022-12-06
• Study Completion: 2022-12-06
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-22
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Medicine Greifswald; 🇩🇪 Greifswald, Germany