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2020-06-25
2022-12-06
2022-12-06
66
NCT04476082
University Medicine Greifswald
University Medicine Greifswald
OBSERVATIONAL
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-06-29 | N/A | 2023-01-22 |
2020-07-13 | N/A | 2023-01-25 |
2020-07-17 | N/A | 2023-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/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
|
| : Ongoing Cytostatic Treatment Patients with a malignant condition of the gastrointestinal tract already receiving cytostatic treatment. | OTHER: No intervention - observational study only
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| Skeletal Muscle Mass | Changes in the skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA) | 3 months after study enrollment |
| Fat Free Mass | Changes in the fat free mass measured by Bioelectrical Impedance Analysis (BIA) | 3 months after study enrollment |
| Fat Mass | Changes in the fat mass measured by Bioelectrical Impedance Analysis (BIA) | 3 months after study enrollment |
| Total Body Water | Changes in the total Body water measured by Bioelectrical Impedance Analysis (BIA) | 3 months after study enrollment |
| Extracellular Water | Changes in the total extracellular water measured by Bioelectrical Impedance Analysis (BIA) | 3 months after study enrollment |
| Phase Angle | Changes in the phase angle measured by Bioelectrical Impedance Analysis (BIA) | 3 months after study enrollment |
| Body Weight | Changes in body weight measured in kilograms | 3 months after study enrollment |
| Height | Changes in height measured in meters | 3 months after study enrollment |
| 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 |
| Waist Circumference | Changes in waist circumference measured in centimeters | 3 months after study enrollment |
| Hip Circumference | Changes in hip circumference measured in centimeters | 3 months after study enrollment |
| 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 |
| Upper Arm Circumference | Changes in upper arm circumference measured in centimeters | 3 months after study enrollment |
| Triceps Skinfold Thickness | Changes in triceps skinfold thickness measured in millimeters | 3 months after study enrollment |
| Muscle Strength | Changes in muscle strength measured by a handgrip strength dynamometer | 3 months after study enrollment |
| Muscle Function | Changes in muscle function measured by a 4-m gait speed test | 3 months after study enrollment |
| 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 |
| Energy Intake | Changes in energy intake assessed by 3-day weighed dietary record | 3 months after study enrollment |
| Protein Intake | Changes in protein intake (in g/day) assessed by 3-day weighed dietary record | 3 months after study enrollment |
| Carbohydrate Intake | Changes in carbohydrate intake (in g/day) assessed by 3-day weighed dietary record | 3 months after study enrollment |
| Fat Intake | Changes in fat intake (in g/day) assessed by 3-day weighed dietary record | 3 months after study enrollment |
| Dietary Fiber Intake | Changes in dietary fiber intake (in g/day) assessed by 3-day weighed dietary record | 3 months after study enrollment |
| 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 |
| Complete Blood Count | Changes in complete blood count | 3 months after study enrollment |
| Albumin | Changes in plasma concentration of albumin | 3 months after study enrollment |
| Aspartate Transaminase | Changes in plasma concentration of aspartate transferase | 3 months after study enrollment |
| Alanine Aminotransferase | Changes in plasma concentration of alanine aminotransferase | 3 months after study enrollment |
| Gamma-glutamyl Transferase | Changes in plasma concentration of gamma-glutamyl transferase | 3 months after study enrollment |
| Bilirubin | Changes in plasma concentration of bilirubin | 3 months after study enrollment |
| Creatinine | Changes in plasma concentration of creatinine | 3 months after study enrollment |
| Urea | Changes in plasma concentration of urea | 3 months after study enrollment |
| C-reactive Protein | Changes in plasma concentration of C-reactive protein | 3 months after study enrollment |
| Plasma Metabolome | Changes in plasma metabolome | 3 months after study enrollment |
| Plasma Transcriptome | Changes in plasma transcriptome | 3 months after study enrollment |
| Intestinal Microbiome | Changes in intestinal microbiome | 3 months after study enrollment |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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