Pancreatic CancerNutriGITNCT04476082
Nutrition in Gastrointestinal Tumors
An observational study of Pancreatic Cancer and Oesophageal Cancer, run by University Medicine Greifswald at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Oesophageal Cancer, Colon Cancer
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jun 2020to 6 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited at University Medicine Greifswald (Northeast Germany). Patients with initial diagnosis of a malignant condition of the gastrointestinal tract planned to receive cytostatic treatment will be identified in the gastrointestinal ward of the hosptial. Recruitment of patients receiving cytostatic treatment of a known malignant condition of the gastrointestinal tract will take place in the hospital's cancer day unit.
Who may be able to join
- 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
Who cannot join
- pregnancy
- history of any other malignant tumor disease
- inability to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Nutritional Status in Patients With Malignant Tumor Diseases of the Gastrointestinal Tract
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.
Read the 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.
- Conditions
- Pancreatic Cancer, Oesophageal Cancer, Colon Cancer, Liver Cancer, Rectal Cancer, Bile Duct Cancer
- Being tested
- No intervention - observational study only
- Medical subject headings
- Pancreatic Neoplasms, Esophageal Neoplasms, Colonic Neoplasms, Liver Neoplasms, Rectal Neoplasms, Bile Duct Neoplasms, Gastrointestinal Stromal Tumors, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - observational study onlyOther
No intervention - observational study only
| Study group | Role | What they receive |
|---|---|---|
| Initial Diagnosis | Patients with initial diagnosis of a malignant condition of the gastrointestinal tract planned to receive cytostatic treatment. Receives: Other: No intervention - observational study only | |
| Ongoing Cytostatic Treatment | Patients with a malignant condition of the gastrointestinal tract already receiving cytostatic treatment. Receives: Other: No intervention - observational study only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Malnutrition According to the Global Leadership Initiative on Malnutrition criteria (GLIM criteria)
Change in prevalence of malnutrition according to the GLIM criteria
Measured: 3 months after study enrollment
Secondary outcomes (36)
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
Measured: 3 months after study enrollment
Skeletal Muscle Mass
Changes in the skeletal muscle mass measured by Bioelectrical Impedance Analysis (BIA)
Measured: 3 months after study enrollment
Fat Free Mass
Changes in the fat free mass measured by Bioelectrical Impedance Analysis (BIA)
Measured: 3 months after study enrollment
Fat Mass
Changes in the fat mass measured by Bioelectrical Impedance Analysis (BIA)
Measured: 3 months after study enrollment
Total Body Water
Changes in the total Body water measured by Bioelectrical Impedance Analysis (BIA)
Measured: 3 months after study enrollment
Extracellular Water
Changes in the total extracellular water measured by Bioelectrical Impedance Analysis (BIA)
Measured: 3 months after study enrollment
Phase Angle
Changes in the phase angle measured by Bioelectrical Impedance Analysis (BIA)
Measured: 3 months after study enrollment
Body Weight
Changes in body weight measured in kilograms
Measured: 3 months after study enrollment
Height
Changes in height measured in meters
Measured: 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)
Measured: 3 months after study enrollment
Waist Circumference
Changes in waist circumference measured in centimeters
Measured: 3 months after study enrollment
Hip Circumference
Changes in hip circumference measured in centimeters
Measured: 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)
Measured: 3 months after study enrollment
Upper Arm Circumference
Changes in upper arm circumference measured in centimeters
Measured: 3 months after study enrollment
Triceps Skinfold Thickness
Changes in triceps skinfold thickness measured in millimeters
Measured: 3 months after study enrollment
Muscle Strength
Changes in muscle strength measured by a handgrip strength dynamometer
Measured: 3 months after study enrollment
Muscle Function
Changes in muscle function measured by a 4-m gait speed test
Measured: 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
Measured: 3 months after study enrollment
Energy Intake
Changes in energy intake assessed by 3-day weighed dietary record
Measured: 3 months after study enrollment
Protein Intake
Changes in protein intake (in g/day) assessed by 3-day weighed dietary record
Measured: 3 months after study enrollment
Carbohydrate Intake
Changes in carbohydrate intake (in g/day) assessed by 3-day weighed dietary record
Measured: 3 months after study enrollment
Fat Intake
Changes in fat intake (in g/day) assessed by 3-day weighed dietary record
Measured: 3 months after study enrollment
Dietary Fiber Intake
Changes in dietary fiber intake (in g/day) assessed by 3-day weighed dietary record
Measured: 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
Measured: 3 months after study enrollment
Complete Blood Count
Changes in complete blood count
Measured: 3 months after study enrollment
Albumin
Changes in plasma concentration of albumin
Measured: 3 months after study enrollment
Aspartate Transaminase
Changes in plasma concentration of aspartate transferase
Measured: 3 months after study enrollment
Alanine Aminotransferase
Changes in plasma concentration of alanine aminotransferase
Measured: 3 months after study enrollment
Gamma-glutamyl Transferase
Changes in plasma concentration of gamma-glutamyl transferase
Measured: 3 months after study enrollment
Bilirubin
Changes in plasma concentration of bilirubin
Measured: 3 months after study enrollment
Creatinine
Changes in plasma concentration of creatinine
Measured: 3 months after study enrollment
Urea
Changes in plasma concentration of urea
Measured: 3 months after study enrollment
C-reactive Protein
Changes in plasma concentration of C-reactive protein
Measured: 3 months after study enrollment
Plasma Metabolome
Changes in plasma metabolome
Measured: 3 months after study enrollment
Plasma Transcriptome
Changes in plasma transcriptome
Measured: 3 months after study enrollment
Intestinal Microbiome
Changes in intestinal microbiome
Measured: 3 months after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start25 Jun 2020
- Primary completion6 Dec 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali A Aghdassi, Professor, Principal investigator, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476082
- Sponsor's protocol ID
- BB 071/20
- Acronym
- NutriGIT
- Status last verified
- Jan 2023
- First submitted
- 29 Jun 2020
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Nutritional Status in Patients With Malignant Tumor Diseases of the Gastrointestinal Tract
- ClinicalTrials.gov ID
- NCT04476082
- Acronym / sponsor ID
- NutriGIT / BB 071/20
- Conditions
- Pancreatic Cancer, Oesophageal Cancer, Colon Cancer, Liver Cancer, Rectal Cancer, Bile Duct Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial Diagnosis | – | Other: No intervention - observational study onlyPatients with initial diagnosis of a malignant condition of the gastrointestinal tract planned to receive cytostatic treatment. |
| Ongoing Cytostatic Treatment | – | Other: No intervention - observational study onlyPatients with a malignant condition of the gastrointestinal tract already receiving cytostatic treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited at University Medicine Greifswald (Northeast Germany). Patients with initial diagnosis of a malignant condition of the gastrointestinal tract planned to receive cytostatic treatment will be identified in the gastrointestinal ward of the hosptial. Recruitment of patients receiving cytostatic treatment of a known malignant condition of the gastrointestinal tract will take place in the hospital's cancer day unit.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- pregnancy
- history of any other malignant tumor disease
- inability to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention - observational study onlyNo intervention - observational study only | Other | Initial Diagnosis, Ongoing Cytostatic Treatment |
Primary outcome
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
36 secondary outcomes
Prevalence of Malnutrition According to the European Society for Clinical Nutrition and Metabolism criteria (ESPEN criteria)
Time frame: 3 months after study enrollment
Skeletal Muscle Mass
Time frame: 3 months after study enrollment
Fat Free Mass
Time frame: 3 months after study enrollment
Fat Mass
Time frame: 3 months after study enrollment
Total Body Water
Time frame: 3 months after study enrollment
Extracellular Water
Time frame: 3 months after study enrollment
Phase Angle
Time frame: 3 months after study enrollment
Body Weight
Time frame: 3 months after study enrollment
Height
Time frame: 3 months after study enrollment
Body Mass Index
Time frame: 3 months after study enrollment
Waist Circumference
Time frame: 3 months after study enrollment
Hip Circumference
Time frame: 3 months after study enrollment
Waist-to-Hip Ratio
Time frame: 3 months after study enrollment
Upper Arm Circumference
Time frame: 3 months after study enrollment
Triceps Skinfold Thickness
Time frame: 3 months after study enrollment
Muscle Strength
Time frame: 3 months after study enrollment
Muscle Function
Time frame: 3 months after study enrollment
Sarcopenia According to the European Working Group on Sarcopenia in Older People 2 criteria (EWGSOP2 criteria)
Time frame: 3 months after study enrollment
Energy Intake
Time frame: 3 months after study enrollment
Protein Intake
Time frame: 3 months after study enrollment
Carbohydrate Intake
Time frame: 3 months after study enrollment
Fat Intake
Time frame: 3 months after study enrollment
Dietary Fiber Intake
Time frame: 3 months after study enrollment
Physical Activity
Time frame: 3 months after study enrollment
Complete Blood Count
Time frame: 3 months after study enrollment
Albumin
Time frame: 3 months after study enrollment
Aspartate Transaminase
Time frame: 3 months after study enrollment
Alanine Aminotransferase
Time frame: 3 months after study enrollment
Gamma-glutamyl Transferase
Time frame: 3 months after study enrollment
Bilirubin
Time frame: 3 months after study enrollment
Creatinine
Time frame: 3 months after study enrollment
Urea
Time frame: 3 months after study enrollment
C-reactive Protein
Time frame: 3 months after study enrollment
Plasma Metabolome
Time frame: 3 months after study enrollment
Plasma Transcriptome
Time frame: 3 months after study enrollment
Intestinal Microbiome
Time frame: 3 months after study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali A Aghdassi, Professor principal investigator
University Medicine Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Oesophageal Cancer, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Malnutrition According to the Global Leadership Initiative on Malnutrition criteria (GLIM criteria) (time frame: 3 months after study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.