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JOURNAL ONKOLOGIE – STUDIE
NutriGIT

Nutrition in Gastrointestinal Tumors

Rekrutierend

NCT-Nummer:
NCT04476082

Studienbeginn:
Juni 2020

Letztes Update:
17.07.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Neuroendocrine Tumors, Bile Duct Neoplasms, Cholangiocarcinoma, Intestinal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Medicine Greifswald

Collaborator:
-

Studienleiter

Prof. Dr. med. Markus M. Lerch
Principal Investigator
University Medicine Greifswald

Kontakt

Prof. Dr. med. Markus M. Lerch
Kontakt:
Phone: +493834867230
E-Mail: markus.lerch@med.uni-greifswald.de
» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University Medicine Greifswald
17475 Greifswald
(Mecklenburg-Vorpommern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Prof. Dr. med. Markus M. Lerch
Phone: +493834867230
E-Mail: markus.lerch@med.uni-greifswald.de

Dr. med. Ali A. Aghdassi
Phone: +4938348680762
E-Mail: ali.aghdassi@med.uni-greifswald.de
» Ansprechpartner anzeigen

Studien-Informationen

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.
 

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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 outcome:

1. Prevalence of Malnutrition According to the European Society for Clinical Nutrition and Metabolism criteria (ESPEN criteria) (Time Frame - 3 months after study enrollment):
Change in prevalence of malnutrition according to the ESPEN criteria

2. Skeletal Muscle Mass (Time Frame - 3 months after study enrollment):
Changes in the skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA)

3. Fat Free Mass (Time Frame - 3 months after study enrollment):
Changes in the fat free mass measured by Bioelectrical Impedance Analysis (BIA)

4. Fat Mass (Time Frame - 3 months after study enrollment):
Changes in the fat mass measured by Bioelectrical Impedance Analysis (BIA)

5. Total Body Water (Time Frame - 3 months after study enrollment):
Changes in the total Body water measured by Bioelectrical Impedance Analysis (BIA)

6. Extracellular Water (Time Frame - 3 months after study enrollment):
Changes in the total extracellular water measured by Bioelectrical Impedance Analysis (BIA)

7. Phase Angle (Time Frame - 3 months after study enrollment):
Changes in the phase angle measured by Bioelectrical Impedance Analysis (BIA)

8. Body Weight (Time Frame - 3 months after study enrollment):
Changes in body weight measured in kilograms

9. Height (Time Frame - 3 months after study enrollment):
Changes in height measured in meters

10. Body Mass Index (Time Frame - 3 months after study enrollment):
Changes in body mass index in kg/m^2 (calculated from the values obtained for body weight and height)

11. Waist Circumference (Time Frame - 3 months after study enrollment):
Changes in waist circumference measured in centimeters

12. Hip Circumference (Time Frame - 3 months after study enrollment):
Changes in hip circumference measured in centimeters

13. Waist-to-Hip Ratio (Time Frame - 3 months after study enrollment):
Changes in waist-to-hip ratio (calculated from the values obtained for waist and hip circumference)

14. Upper Arm Circumference (Time Frame - 3 months after study enrollment):
Changes in upper arm circumference measured in centimeters

15. Triceps Skinfold Thickness (Time Frame - 3 months after study enrollment):
Changes in triceps skinfold thickness measured in millimeters

16. Muscle Strength (Time Frame - 3 months after study enrollment):
Changes in muscle strength measured by a handgrip strength dynamometer

17. Muscle Function (Time Frame - 3 months after study enrollment):
Changes in muscle function measured by a 4-m gait speed test

18. Sarcopenia According to the European Working Group on Sarcopenia in Older People 2 criteria (EWGSOP2 criteria) (Time Frame - 3 months after study enrollment):
Change in prevalence of sarcopenia according to the EWGSOP2 criteria

19. Energy Intake (Time Frame - 3 months after study enrollment):
Changes in energy intake assessed by 3-day weighed dietary record

20. Protein Intake (Time Frame - 3 months after study enrollment):
Changes in protein intake (in g/day) assessed by 3-day weighed dietary record

21. Carbohydrate Intake (Time Frame - 3 months after study enrollment):
Changes in carbohydrate intake (in g/day) assessed by 3-day weighed dietary record

22. Fat Intake (Time Frame - 3 months after study enrollment):
Changes in fat intake (in g/day) assessed by 3-day weighed dietary record

23. Dietary Fiber Intake (Time Frame - 3 months after study enrollment):
Changes in dietary fiber intake (in g/day) assessed by 3-day weighed dietary record

24. Physical Activity (Time Frame - 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

25. Complete Blood Count (Time Frame - 3 months after study enrollment):
Changes in complete blood count

26. Albumin (Time Frame - 3 months after study enrollment):
Changes in plasma concentration of albumin

27. Aspartate Transaminase (Time Frame - 3 months after study enrollment):
Changes in plasma concentration of aspartate transferase

28. Alanine Aminotransferase (Time Frame - 3 months after study enrollment):
Changes in plasma concentration of alanine aminotransferase

29. Gamma-glutamyl Transferase (Time Frame - 3 months after study enrollment):
Changes in plasma concentration of gamma-glutamyl transferase

30. Bilirubin (Time Frame - 3 months after study enrollment):
Changes in plasma concentration of bilirubin

31. Creatinine (Time Frame - 3 months after study enrollment):
Changes in plasma concentration of creatinine

32. Urea (Time Frame - 3 months after study enrollment):
Changes in plasma concentration of urea

33. C-reactive Protein (Time Frame - 3 months after study enrollment):
Changes in plasma concentration of C-reactive protein

34. Plasma Metabolome (Time Frame - 3 months after study enrollment):
Changes in plasma metabolome

35. Plasma Transcriptome (Time Frame - 3 months after study enrollment):
Changes in plasma transcriptome

36. Intestinal Microbiome (Time Frame - 3 months after study enrollment):
Changes in intestinal microbiome

Studien-Arme

  • Initial Diagnosis
    Patients with initial diagnosis of a malignant condition of the gastrointestinal tract planned to receive cytostatic treatment.
  • Ongoing Cytostatic Treatment
    Patients with a malignant condition of the gastrointestinal tract already receiving cytostatic treatment.

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


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