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NCT Number: NCT04476082

Nutrition in Gastrointestinal Tumors

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.

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Key information

Conditions

Pancreatic Cancer Bile Duct Cancer Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms GIST, Malignant Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Oesophageal Cancer Pancreatic Diseases Pancreatic Neoplasms Rectal Cancer Rectal Diseases Rectal Neoplasms Small Intestine Cancer Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medicine Greifswald

Greifswald, 17475, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention - observational study only

Other

No intervention - observational study only

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Registry information

Official study title

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

Acronym: NutriGIT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 17, 2020
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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