Colorectal CancerNCT06016829
Preoperative Nutritional Status and Postoperative Outcomes in Colorectal Cancer
An observational study of Colorectal Cancer, run by Hacettepe University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effect of preoperative nutritional status, dietary inflammatory index, and systemic inflammatory response on postoperative outcomes. The study will include 120 colorectal cancer patients who are scheduled for surgical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Nutrition Risk Screening 2002 (NRS-2002), Global Leadership Initiative on Malnutrition (GLIM) and Measurement of body composition with computed tomography (CT)
- Type of treatment
- Injection or infusion
- How many people
- 121 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 25 Jul 2021to 1 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 aged 18 years and older who have undergone surgical treatment for a diagnosis of colorectal cancer
Who may be able to join
- Having been diagnosed with colorectal cancer and having surgical treatment planned
- Being 18 years of age or older
Who cannot join
- Having received chemotherapy or radiotherapy
- Currently undergoing corticosteroid or hormone treatment.
- Presence of distant metastases.
- Presence of any malignancy other than colorectal cancer.
- Presence of autoimmune disease.
- Presence of ongoing infectious disease.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Hacettepe University
Ankara, 06100
Ankara City Hospital Bilkent
Ankara, 06800
About this study
Official title: The Effect of Preoperative Nutritional Status, Dietary Inflammatory Index and Systemic Inflammatory Response on Postoperative Outcomes in Colorectal Cancer.
The aim of this study was to evaluate the effect of preoperative nutritional status, dietary inflammatory index, and systemic inflammatory response on postoperative outcomes. The study will include 120 colorectal cancer patients who are scheduled for surgical treatment.
Read the detailed description
A questionnaire form containing general information, dietary habits, and food consumption records will be applied by the researcher in the preoperative period to the patients who volunteered to participate in the study. Body composition will be taken by bioelectrical impedance analysis method. Hand grip strength will be taken with a digital hand dynamometer. The nutritional status of patients will be assessed using the criteria of the Nutritional Risk Screening 2002 (NRS-2002) and the Global Leadership Initiative on Malnutrition (GLIM). For body composition analysis, computed tomography images, known as the gold standard, will be used in cancer patients. Computed tomography images of the patients will be obtained from hospital records at L3 lumbar vertebra level. The software program ImageJ developed by the US National Institute of Health will be used to calculate the visceral fat area (cm2), subcutaneous fat area (cm2), and skeletal muscle area (cm2) from the recorded images.
Preoperative biochemical parameters will be obtained from hospital records. The systemic inflammatory response will be determined by the Prognostic Nutritional Index, Neutrophil Lymphocyte Ratio, and Delta Neutrophil Index. The inflammatory load of the diet will be calculated using the Dietary Inflammatory Index. The quality of life of patients will be assessed using cancer-specific scales developed by the European Organisation for Research and Treatment of Cancer (EORTC) during the preoperative and postoperative periods. These scales are EORTC-QLQ-C30 for general quality of life and EORTC-QLQ-CR29 for colorectal cancer-specific quality of life.
- Conditions
- Colorectal Cancer
- Being tested
- Nutrition Risk Screening 2002 (NRS-2002), Global Leadership Initiative on Malnutrition (GLIM), Measurement of body composition with computed tomography (CT), Dietary inflammatory index (DII), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
- Keywords
- colorectal cancer, nutritional status, body composition, quality of life, postoperative complication
- Medical subject headings
- Colorectal Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition Risk Screening 2002 (NRS-2002)Diagnostic test
Nutritional status assessment tool
Global Leadership Initiative on Malnutrition (GLIM)Diagnostic test
Nutritional status assessment tool
Measurement of body composition with computed tomography (CT)Other
The cross section of the third lumbar vertebrae in the CT scan images of the patients will be analyzed for assessment of body composition parameters including skeletal muscle area (SMA), visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT)
Dietary inflammatory index (DII)Diagnostic test
The Dietary Inflammatory Index (DII) is a scoring algorithm that indicates the inflammatory potential of the diet.
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)Diagnostic test
Quality of life assessment tool
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC-QLQ-CR29)Diagnostic test
Quality of life assessment tool
Prognostic Nutritional Index (PNI)Diagnostic test
Prognostic Nutritional Index is diagnostic test based on serum albumin level and total lymphocyte count
Neutrophil-Lymphocyte Ratio (NLR)Diagnostic test
The neutrophil-to-lymphocyte ratio (NLR) is calculated as the simple ratio between neutrophil and lymphocyte counts.
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Complications graded by Clavien-Dindo Complication Classification System
Measured: within 30 days after surgery
Postoperative quality of life
Quality of life will be evaluated by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30).All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: within 45 days after surgery
EORTC-QLQ-CR29
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC-QLQ-CR29) is a supplementary questionnaire module to be employed in conjunction with the Quality of Life Questionnaire Core 30 (QLQ-C30). All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scale and functional single-items represents a high level of functioning, whereas a high score for the symptom scales and symptom single-items represents a high level of symptomatology or problem.
Measured: within 45 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start25 Jul 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Responsible party
- Principal investigator, Tuba Nur Yildiz Kopuz, Hacettepe University
- Investigators
- Tuba N Yildiz Kopuz, Principal investigator, Hacettepe UniversityMehmet Fisunoglu, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016829
- Sponsor's protocol ID
- GO 21/499
- Status last verified
- Feb 2024
- First submitted
- 23 Aug 2023
- Last updated
- 28 Feb 2024
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Nutritional Status, Dietary Inflammatory Index and Systemic Inflammatory Response on Postoperative Outcomes in Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT06016829
- Acronym / sponsor ID
- GO 21/499
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, nutritional status, body composition, quality of life, postoperative complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Study start
- 25 Jul 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 30 Aug 2023 (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.
The aim of this study was to evaluate the effect of preoperative nutritional status, dietary inflammatory index, and systemic inflammatory response on postoperative outcomes. The study will include 120 colorectal cancer patients who are scheduled for surgical treatment.
Detailed description
A questionnaire form containing general information, dietary habits, and food consumption records will be applied by the researcher in the preoperative period to the patients who volunteered to participate in the study. Body composition will be taken by bioelectrical impedance analysis method. Hand grip strength will be taken with a digital hand dynamometer. The nutritional status of patients will be assessed using the criteria of the Nutritional Risk Screening 2002 (NRS-2002) and the Global Leadership Initiative on Malnutrition (GLIM). For body composition analysis, computed tomography images, known as the gold standard, will be used in cancer patients. Computed tomography images of the patients will be obtained from hospital records at L3 lumbar vertebra level. The software program ImageJ developed by the US National Institute of Health will be used to calculate the visceral fat area (cm2), subcutaneous fat area (cm2), and skeletal muscle area (cm2) from the recorded images.
Preoperative biochemical parameters will be obtained from hospital records. The systemic inflammatory response will be determined by the Prognostic Nutritional Index, Neutrophil Lymphocyte Ratio, and Delta Neutrophil Index. The inflammatory load of the diet will be calculated using the Dietary Inflammatory Index. The quality of life of patients will be assessed using cancer-specific scales developed by the European Organisation for Research and Treatment of Cancer (EORTC) during the preoperative and postoperative periods. These scales are EORTC-QLQ-C30 for general quality of life and EORTC-QLQ-CR29 for colorectal cancer-specific quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years and older who have undergone surgical treatment for a diagnosis of colorectal cancer
Key inclusion criteria (2 listed)
- Having been diagnosed with colorectal cancer and having surgical treatment planned
- Being 18 years of age or older
Key exclusion criteria (6 listed)
- Having received chemotherapy or radiotherapy
- Currently undergoing corticosteroid or hormone treatment.
- Presence of distant metastases.
- Presence of any malignancy other than colorectal cancer.
- Presence of autoimmune disease.
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 |
|---|---|---|
| Nutrition Risk Screening 2002 (NRS-2002)Nutritional status assessment tool | Diagnostic test | – |
| Global Leadership Initiative on Malnutrition (GLIM)Nutritional status assessment tool | Diagnostic test | – |
| Measurement of body composition with computed tomography (CT)The cross section of the third lumbar vertebrae in the CT scan images of the patients will be analyzed for assessment of body composition parameters including skeletal muscle area (SMA), visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT) | Other | – |
| Dietary inflammatory index (DII)The Dietary Inflammatory Index (DII) is a scoring algorithm that indicates the inflammatory potential of the diet. | Diagnostic test | – |
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)Quality of life assessment tool | Diagnostic test | – |
| European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC-QLQ-CR29)Quality of life assessment tool | Diagnostic test | – |
| Prognostic Nutritional Index (PNI)Prognostic Nutritional Index is diagnostic test based on serum albumin level and total lymphocyte count | Diagnostic test | – |
| Neutrophil-Lymphocyte Ratio (NLR)The neutrophil-to-lymphocyte ratio (NLR) is calculated as the simple ratio between neutrophil and lymphocyte counts. | Diagnostic test | – |
Primary outcome
Postoperative complications
Time frame: within 30 days after surgery
Complications graded by Clavien-Dindo Complication Classification System
Postoperative quality of life
Time frame: within 45 days after surgery
Quality of life will be evaluated by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30).All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
EORTC-QLQ-CR29
Time frame: within 45 days after surgery
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC-QLQ-CR29) is a supplementary questionnaire module to be employed in conjunction with the Quality of Life Questionnaire Core 30 (QLQ-C30). All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scale and functional single-items represents a high level of functioning, whereas a high score for the symptom scales and symptom single-items represents a high level of symptomatology or problem.
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 28 Feb 2024.
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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.
Tuba N Yildiz Kopuz principal investigator
Hacettepe University
Mehmet Fisunoglu principal investigator
Hacettepe University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Hacettepe University at 2 sites in Turkey (Türkiye).
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 6 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Postoperative complications (time frame: within 30 days after surgery). The study lists 3 primary outcomes in all. 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 28 Feb 2024.