Immunologic Changes and Recovery-related Factors in Elderly Colon Cancer Patients

Phase 2

Completed

• Conditions: Cancer of Colon; Interleukins; Aged
• Interventions: Other: Blood test

• Registration Number: NCT06454071
• Lead Sponsor: Soonchunhyang University Hospital

Brief Summary

Colorectal cancer is one of the most frequent malignancies, with a rising proportion of elderly patients in an aging society. In this study, the investigators attempted to find out the relationship between immunologic factors and recovery using various parameters impacting the treatment in elderly patients.

Detailed Description

In prospective study, total 75 patients who received radical resection for colon cancer between September 2023 and February 2024 at Asan Medical Center was involved. Investigators included colon cancer patients treated with surgery, diagnosed with adenocarcinoma histologically and having information regarding preoperative status with abdominopelvic CT. Routine blood sampling and Immunologic tests including interleukin-6 (IL-6) and natural killer cell (NK cell) were performed at preoperative day, post operative 3rd day (POD#3), and outpatient clinic day (about postoperative 21th day (POD#21)). Investigators attempted to assess the patients' subjective health level using a simple questionnaire, EuroQol group- 5 dimension- 3 level (EQ-5D-3L). The sarcopenia was evaluated by the artificial intelligence software system and defined as an SMI \< 41cm2/m2 in women and SMI \< 43 cm2/m2 in men with a body mass index (BMI) \< 25kg/m2, and \< 53 cm2/m2 in men with a BMI ≥ 25 kg/m2.

In this study, primary end point was recovery represented by hospital stay defined as the day from operation to discharge and readmission within 30days after discharge. Secondary end point was EQ-5D-3L (only in prospective cohort). 'Recovery' was evaluated by hospital stay and readmission within 30 days after discharge. Analyses of clinicopathological characteristics of categorical variables and continuous variables were conducted using the chi-square test and t-test, respectively. A multivariable analysis with Cox proportional hazards model was used to compare risk factors associated with postoperative hospital day including NLR, AGR, albumin, BMI and sarcopenia. Investigators conducted an analysis including variables that have been proven to be related to the immune system or recovery in previous studies or that are suspected to be clinically relevant.

Study Timeline

• Study Start: 2023-09-04
• Primary Completion: 2024-02-02
• Status Verified: 2024-05
• Study Completion: 2024-05-29
• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-06-11
• Last Update Submitted: 2024-06-11
• Study First Posted: 2024-06-12
• Last Update Posted: 2024-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• colon cancer patients treated with surgery
• diagnosed with adenocarcinoma histologically
• having information regarding preoperative status with abdominopelvic CT

Exclusion Criteria

• familial colorectal cancer
• malignancies other than adenocarcinoma
• inflammatory bowel disease-associated cancer
• recurrence
• metastasis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interleukin6	Blood test	Immunologic tests including Interleukin 6 were conducted before surgery, on the third day following surgery, and on the first outpatient visit day (approximately 21 days after surgery). The IL-6 tests were carried out in our hospital.
NK cell	Blood test	Immunologic tests including Nk cell were conducted before surgery, on the third day following surgery, and on the first outpatient visit day (approximately 21 days after surgery). The NK cell tests were carried out in our hospital. Peripheral blood mononuclear cells were evaluated using flow cytometry via fluorochrome-conjugated antibodies against a number of NK cell receptors.

Primary Outcome Measures

Name	Time	Method
Differences of recovery in between elderly and elderly patients	up to 1 month	The primary end point was' recovery' represented by hospital stay. Investigators evaluated 'Recovery' by hospital stay and readmission within 30 days after discharge. Investigators categorized the patients who had a shorter-than-average hospital stay as 'fast' group, and patietns who had a longer-than-average hospital stay or readmitted within 30 days after discharge rated their recovery as 'slow' group.

Trial Locations

Locations (1)

Soonchunhyang University Hospital; 🇰🇷 Seoul, Korea, Republic of