Clinical trial NCT06454071: Immunologic Changes and Recovery-related Factors in Elderly Colon Cancer Patients
Official title: Relationship Between Immunologic Changes and Recovery-related Factors in the Recovery Process of Elderly Colon Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer of Colon
Interleukins
Aged
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The entire number of patients was divided into elderly and non-elderly groups based on the age of 70. 29 patients were assigned in elderly group, and 46 patients were assigned in non-elderly group. Preoperative blood sampling including WBC, lymphocyte, neutrophil, albumin, globulin was performed for all patients. In case of participants, investigators added the additional blood tests including immunologic markers including Interleukin-6 and Natural killer cell. These blood tests including immunologic markers were conducted before surgery, on the third day following surgery, and on the first outpatient visit day (approximately 21 days after surgery)
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences of recovery in between elderly and elderly patients
timeFrame: up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital
Study officials:
affiliation: Soonchunhyang University Hospital
name: Byeo Lee Lim, Dr
role: STUDY_DIRECTOR
References: