Nutrition in Gastrointestinal Tumors

Pancreatic Cancer Clinical Trial

— NutriGIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04476082
• Other study ID #: BB 071/20
• Status: Completed
• Start date: June 25, 2020
• Est. completion date: December 6, 2022

Study information

• Verified date: January 2023
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 6, 2022
• Est. primary completion date: December 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Cancer
• Bile Duct Neoplasms
• Cholangiocarcinoma
• Colon Cancer
• Gastric Cancer
• GIST, Malignant
• Intestinal Neoplasms
• Liver Cancer
• Neuroendocrine Tumors
• Oesophageal Cancer
• Pancreatic Cancer
• Rectal Cancer
• Small Intestine Cancer

Intervention

Other:
• No intervention - observational study only
No intervention - observational study only

Locations

Country	Name	City	State
Germany	University Medicine Greifswald	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Skeletal Muscle Mass	Changes in the skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA)	3 months after study enrollment
Secondary	Fat Free Mass	Changes in the fat free mass measured by Bioelectrical Impedance Analysis (BIA)	3 months after study enrollment
Secondary	Fat Mass	Changes in the fat mass measured by Bioelectrical Impedance Analysis (BIA)	3 months after study enrollment
Secondary	Total Body Water	Changes in the total Body water measured by Bioelectrical Impedance Analysis (BIA)	3 months after study enrollment
Secondary	Extracellular Water	Changes in the total extracellular water measured by Bioelectrical Impedance Analysis (BIA)	3 months after study enrollment
Secondary	Phase Angle	Changes in the phase angle measured by Bioelectrical Impedance Analysis (BIA)	3 months after study enrollment
Secondary	Body Weight	Changes in body weight measured in kilograms	3 months after study enrollment
Secondary	Height	Changes in height measured in meters	3 months after study enrollment
Secondary	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
Secondary	Waist Circumference	Changes in waist circumference measured in centimeters	3 months after study enrollment
Secondary	Hip Circumference	Changes in hip circumference measured in centimeters	3 months after study enrollment
Secondary	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
Secondary	Upper Arm Circumference	Changes in upper arm circumference measured in centimeters	3 months after study enrollment
Secondary	Triceps Skinfold Thickness	Changes in triceps skinfold thickness measured in millimeters	3 months after study enrollment
Secondary	Muscle Strength	Changes in muscle strength measured by a handgrip strength dynamometer	3 months after study enrollment
Secondary	Muscle Function	Changes in muscle function measured by a 4-m gait speed test	3 months after study enrollment
Secondary	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
Secondary	Energy Intake	Changes in energy intake assessed by 3-day weighed dietary record	3 months after study enrollment
Secondary	Protein Intake	Changes in protein intake (in g/day) assessed by 3-day weighed dietary record	3 months after study enrollment
Secondary	Carbohydrate Intake	Changes in carbohydrate intake (in g/day) assessed by 3-day weighed dietary record	3 months after study enrollment
Secondary	Fat Intake	Changes in fat intake (in g/day) assessed by 3-day weighed dietary record	3 months after study enrollment
Secondary	Dietary Fiber Intake	Changes in dietary fiber intake (in g/day) assessed by 3-day weighed dietary record	3 months after study enrollment
Secondary	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
Secondary	Complete Blood Count	Changes in complete blood count	3 months after study enrollment
Secondary	Albumin	Changes in plasma concentration of albumin	3 months after study enrollment
Secondary	Aspartate Transaminase	Changes in plasma concentration of aspartate transferase	3 months after study enrollment
Secondary	Alanine Aminotransferase	Changes in plasma concentration of alanine aminotransferase	3 months after study enrollment
Secondary	Gamma-glutamyl Transferase	Changes in plasma concentration of gamma-glutamyl transferase	3 months after study enrollment
Secondary	Bilirubin	Changes in plasma concentration of bilirubin	3 months after study enrollment
Secondary	Creatinine	Changes in plasma concentration of creatinine	3 months after study enrollment
Secondary	Urea	Changes in plasma concentration of urea	3 months after study enrollment
Secondary	C-reactive Protein	Changes in plasma concentration of C-reactive protein	3 months after study enrollment
Secondary	Plasma Metabolome	Changes in plasma metabolome	3 months after study enrollment
Secondary	Plasma Transcriptome	Changes in plasma transcriptome	3 months after study enrollment
Secondary	Intestinal Microbiome	Changes in intestinal microbiome	3 months after study enrollment