Surveillance of Metabolic Parameters in Patients With Colorectal Cancer

Colorectal Cancer Clinical Trial

— SPRING  

Official title:

Surveillance of Metabolic Parameters in Patients Who Will Receive Chemotherapy After Surgical Resection of Colorectal Cancer: KBSMC Colon Cancer Cohort

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02700555
• Other study ID #: SPRING
• Status: Terminated
• Start date: February 2016
• Est. completion date: February 2020

Study information

• Verified date: December 2022
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

A prospective, single center, cohort study for surveillance of metabolic parameters in patients who will receive chemotherapy after surgical resection of colorectal cancer

Description:

Primary objective - Incidence of newly developed diabetes mellitus in patients with colorectal cancer after post-operative chemotherapy Secondary objective - Pre-operative incidence of diabetes and characteristics of metabolic parameters of patients with colorectal cancer; Incidence of developed poorly controlled glucose level in diabetic patients with colorectal cancer after post-operative chemotherapy; 3-year recurrence-free survival according to status of diabetes and metabolic parameters; 5-year recurrence-free survival according to status of diabetes and metabolic parameters

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Who will get surgical resection for colorectal cancer
• Who has diagnosed with diabetes
• Who met the criteria for testing of diabetes in asymptomatic adult individuals
• Criteria for testing for diabetes in asymptomatic adult individuals
• overweight (BMI>25 kg/m2*) and have additional risk factors (physical inactivity, first-degree relative with diabetes, high-risk race/ethnicity (e.g., African American, Latino, Native American, Asian American, Pacific Islander), women who delivered a baby weighing 0.9 lb or were diagnosed with GDM, hypertension (>140/90 mmHg or on therapy for hypertension), HDL cholesterol level ,35 mg/dL (0.90 mmol/L) and/or a triglyceride level >250 mg/dL (2.82 mmol/L), women with polycystic ovarian syndrome, HbA1C >5.7%, IGT, or IFG on previous testing, other clinical conditions associated with insulin resistance (e.g., severe obesity, acanthosis nigricans), history of CVD)

Exclusion Criteria:

• Previously exposed to surgery or chemotherapy for colorectal cancer
• Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence
• Presence of CNS metastasis
• Not able or willing to give informed consent
• Any patients judged by the investigator to be unfit to participate in the study

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

American Diabetes Association. Standards of medical care in diabetes--2014. Diabetes Care. 2014 Jan;37 Suppl 1:S14-80. doi: 10.2337/dc14-S014. No abstract available. — View Citation

Dienstmann R, Salazar R, Tabernero J. Personalizing colon cancer adjuvant therapy: selecting optimal treatments for individual patients. J Clin Oncol. 2015 Jun 1;33(16):1787-96. doi: 10.1200/JCO.2014.60.0213. Epub 2015 Apr 27. — View Citation

Feng JP, Yuan XL, Li M, Fang J, Xie T, Zhou Y, Zhu YM, Luo M, Lin M, Ye DW. Secondary diabetes associated with 5-fluorouracil-based chemotherapy regimens in non-diabetic patients with colorectal cancer: results from a single-centre cohort study. Colorectal Dis. 2013 Jan;15(1):27-33. doi: 10.1111/j.1463-1318.2012.03097.x. — View Citation

Haggar FA, Boushey RP. Colorectal cancer epidemiology: incidence, mortality, survival, and risk factors. Clin Colon Rectal Surg. 2009 Nov;22(4):191-7. doi: 10.1055/s-0029-1242458. — View Citation

Hwang JL, Weiss RE. Steroid-induced diabetes: a clinical and molecular approach to understanding and treatment. Diabetes Metab Res Rev. 2014 Feb;30(2):96-102. doi: 10.1002/dmrr.2486. — View Citation

Meyerhardt JA, Catalano PJ, Haller DG, Mayer RJ, Macdonald JS, Benson AB 3rd, Fuchs CS. Impact of diabetes mellitus on outcomes in patients with colon cancer. J Clin Oncol. 2003 Feb 1;21(3):433-40. doi: 10.1200/JCO.2003.07.125. — View Citation

Mills KT, Bellows CF, Hoffman AE, Kelly TN, Gagliardi G. Diabetes mellitus and colorectal cancer prognosis: a meta-analysis. Dis Colon Rectum. 2013 Nov;56(11):1304-19. doi: 10.1097/DCR.0b013e3182a479f9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of newly developed diabetes mellitus	Incidence of newly developed diabetes mellitus in patients with colorectal cancer after post-operative chemotherapy	up to 12 months
Secondary	Pre-operative incidence of diabetes	Pre-operative incidence of diabetes (> 6.5% of HbA1c) and abnormal metabolic parameters (> 23 kg/m2 of BMI or dyslipidemia) of patients with colorectal cancer;	up to 12 months
Secondary	Incidence of developed poorly controlled glucose level	Incidence of developed poorly controlled glucose level in diabetic patients with colorectal cancer after post-operative chemotherapy;	up to 12 months
Secondary	3-year recurrence-free survival & 5-year recurrence-free survival	3-year and 5-year recurrence-free survival according to status of diabetes (> 6.5% of HbA1c) and abnormal metabolic parameters (> 23 kg/m2 of BMI or dyslipidemia)	up to 36-60 months