Preoperative Nutritional Status and Postoperative Outcomes in Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

The Effect of Preoperative Nutritional Status, Dietary Inflammatory Index and Systemic Inflammatory Response on Postoperative Outcomes in Colorectal Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06016829
• Other study ID #: GO 21/499
• Status: Completed
• Start date: July 25, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Having been diagnosed with colorectal cancer and having surgical treatment planned

• Being 18 years of age or older

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• Nutrition Risk Screening 2002 (NRS-2002)
Nutritional status assessment tool
• Global Leadership Initiative on Malnutrition (GLIM)
Nutritional status assessment tool

Other:
• 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)

Diagnostic Test:
• Dietary inflammatory index (DII)
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)
Quality of life assessment tool
• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC-QLQ-CR29)
Quality of life assessment tool
• Prognostic Nutritional Index (PNI)
Prognostic Nutritional Index is diagnostic test based on serum albumin level and total lymphocyte count
• Neutrophil-Lymphocyte Ratio (NLR)
The neutrophil-to-lymphocyte ratio (NLR) is calculated as the simple ratio between neutrophil and lymphocyte counts.

Locations

Country	Name	City	State
Turkey	Ankara City Hospital Bilkent	Ankara
Turkey	Hacettepe University	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Hacettepe University	Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	Complications graded by Clavien-Dindo Complication Classification System	within 30 days after surgery
Primary	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.	within 45 days after surgery
Primary	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.	within 45 days after surgery