ECHO: Emergence of Chemotherapy Related Hyperglycemia in nOn-diabetic Patients

Sponsor

National Cancer Center, Korea (Other)

Overall Status

Recruiting

CT.gov ID

NCT03062072

Collaborator

SMG-SNU Boramae Medical Center (Other)

300

Enrollment

Locations

Anticipated Duration (Months)

150

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess chemotherapy related hyperglycemia in non-diabetic patients, the investigators will assess the incidence of hyperglycemia and analyze co-medications and risk factors.

Condition or Disease	Intervention/Treatment	Phase
Cancer Colon Cancer Breast Cancer Malignant Lymphoma	Drug: Chemotherapy

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Emergence of Chemotherapy Related Hyperglycemia in nOn-diabetic Patients (ECHO)

Actual Study Start Date :

Apr 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

Incidence of type 2 diabetes mellitus [during chemotherapy (about 1 year)]
Percentage of patients who progressed to type 2 diabetes

Secondary Outcome Measures

Change in HbA1c [during chemotherapy (about 1 year)]
Change in glycated albumin [during chemotherapy (about 1 year)]
Recurrence free survival (RFS) [from the Date of enrollment to the date of disease recurrence or date of any cause assessed upto 100 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with cancers (colorectal, breast) who treated with curative intents and ones with malignant lymphoma who are expected to achieve complete remission with chemotherapy (mainly, CHOP regimen)
Patients without history of diabetes mellitus
Normal glucose tolerance, as defined in the protocol