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

Aged Clinical Trial

Official title:

Relationship Between Immunologic Changes and Recovery-related Factors in the Recovery Process of Elderly Colon Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06454071
• Other study ID #: Soonchunhyang UH
• Status: Completed
• Phase: Phase 2
• Start date: September 4, 2023
• Est. completion date: May 29, 2024

Study information

• Verified date: May 2024
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 29, 2024
• Est. primary completion date: February 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Aged
• Cancer of Colon
• Colonic Neoplasms
• Interleukins

Intervention

Other:
• 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 and NK cells were carried out in our hospital.

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences of recovery in between elderly and elderly patients	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.	up to 1 month