NutriGIT: Nutrition in Gastrointestinal Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Skeletal Muscle Mass [3 months after study enrollment]
Changes in the skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA)
- Fat Free Mass [3 months after study enrollment]
Changes in the fat free mass measured by Bioelectrical Impedance Analysis (BIA)
- Fat Mass [3 months after study enrollment]
Changes in the fat 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)
- Extracellular Water [3 months after study enrollment]
Changes in the total extracellular 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
- 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)
- Waist Circumference [3 months after study enrollment]
Changes in waist circumference measured in centimeters
- Hip Circumference [3 months after study enrollment]
Changes in hip 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)
- Upper Arm Circumference [3 months after study enrollment]
Changes in upper arm circumference measured in centimeters
- 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
- Muscle Function [3 months after study enrollment]
Changes in muscle function measured by a 4-m gait speed test
- 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
- Energy Intake [3 months after study enrollment]
Changes in energy intake assessed by 3-day weighed dietary record
- 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
- Fat Intake [3 months after study enrollment]
Changes in fat intake (in g/day) assessed by 3-day weighed dietary record
- Dietary Fiber Intake [3 months after study enrollment]
Changes in dietary fiber 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
- Complete Blood Count [3 months after study enrollment]
Changes in complete blood count
- Albumin [3 months after study enrollment]
Changes in plasma concentration of albumin
- Aspartate Transaminase [3 months after study enrollment]
Changes in plasma concentration of aspartate transferase
- Alanine Aminotransferase [3 months after study enrollment]
Changes in plasma concentration of alanine aminotransferase
- 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
- Creatinine [3 months after study enrollment]
Changes in plasma concentration of creatinine
- Urea [3 months after study enrollment]
Changes in plasma concentration of urea
- C-reactive Protein [3 months after study enrollment]
Changes in plasma concentration of C-reactive protein
- Plasma Metabolome [3 months after study enrollment]
Changes in plasma metabolome
- Plasma Transcriptome [3 months after study enrollment]
Changes in plasma transcriptome
- Intestinal Microbiome [3 months after study enrollment]
Changes in intestinal microbiome
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Medicine Greifswald | Greifswald | Germany | 17475 |
Sponsors and Collaborators
- University Medicine Greifswald
Investigators
- Principal Investigator: Prof. Dr. med. Markus M. Lerch, University Medicine Greifswald
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BB 071/20