Analysis of Nutritional Status in Patients With Malignant Tumor Diseases of the Gastrointestinal Tract
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Cancer
- Sponsor
- University Medicine Greifswald
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Prevalence of Malnutrition According to the Global Leadership Initiative on Malnutrition criteria (GLIM criteria)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Prevalence of Malnutrition According to the Global Leadership Initiative on Malnutrition criteria (GLIM criteria)
Time Frame: 3 months after study enrollment
Change in prevalence of malnutrition according to the GLIM criteria
Secondary Outcomes
- Hip Circumference(3 months after study enrollment)
- Energy Intake(3 months after study enrollment)
- C-reactive Protein(3 months after study enrollment)
- Plasma Transcriptome(3 months after study enrollment)
- Waist Circumference(3 months after study enrollment)
- Waist-to-Hip Ratio(3 months after study enrollment)
- Protein Intake(3 months after study enrollment)
- Carbohydrate Intake(3 months after study enrollment)
- Physical Activity(3 months after study enrollment)
- Fat Mass(3 months after study enrollment)
- Extracellular Water(3 months after study enrollment)
- Body Mass Index(3 months after study enrollment)
- Muscle Function(3 months after study enrollment)
- Dietary Fiber Intake(3 months after study enrollment)
- Gamma-glutamyl Transferase(3 months after study enrollment)
- Bilirubin(3 months after study enrollment)
- Urea(3 months after study enrollment)
- Plasma Metabolome(3 months after study enrollment)
- Prevalence of Malnutrition According to the European Society for Clinical Nutrition and Metabolism criteria (ESPEN criteria)(3 months after study enrollment)
- Fat Free Mass(3 months after study enrollment)
- Total Body Water(3 months after study enrollment)
- Phase Angle(3 months after study enrollment)
- Body Weight(3 months after study enrollment)
- Height(3 months after study enrollment)
- Sarcopenia According to the European Working Group on Sarcopenia in Older People 2 criteria (EWGSOP2 criteria)(3 months after study enrollment)
- Fat Intake(3 months after study enrollment)
- Albumin(3 months after study enrollment)
- Alanine Aminotransferase(3 months after study enrollment)
- Skeletal Muscle Mass(3 months after study enrollment)
- Upper Arm Circumference(3 months after study enrollment)
- Triceps Skinfold Thickness(3 months after study enrollment)
- Muscle Strength(3 months after study enrollment)
- Complete Blood Count(3 months after study enrollment)
- Creatinine(3 months after study enrollment)
- Intestinal Microbiome(3 months after study enrollment)
- Aspartate Transaminase(3 months after study enrollment)