Emergence of Chemotherapy Related Hyperglycemia in nOn-diabetic Patients

Breast Cancer Clinical Trial

— ECHO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03062072
• Other study ID #: ECHO
• Secondary ID: NCC2015-0040
• Status: Recruiting
• Phase: N/A
• First received: February 17, 2017
• Last updated: April 5, 2017
• Start date: April 2015
• Est. completion date: December 2022

Study information

• Verified date: April 2017
• Source: National Cancer Center, Korea
• Contact: Su Jeong Go
• Phone: +82-31-920-2364
• Email: sjgo[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2022
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• Patients with diabetes mellitus or hyperglycemia, as defined in the protocol

Related Conditions & MeSH terms

• Breast Cancer
• Cancer
• Colon Cancer
• Hyperglycemia
• Lymphoma
• Malignant Lymphoma

Intervention

Drug:
• Chemotherapy
Chemotherapy containing glucocorticoid as anti-emetics or anti-cancer agent except for targeted agents

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center, Korea	Goyang
Korea, Republic of	Seoul National University Boramae Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Center, Korea	SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of type 2 diabetes mellitus	Percentage of patients who progressed to type 2 diabetes	during chemotherapy (about 1 year)
Secondary	Change in HbA1c		during chemotherapy (about 1 year)
Secondary	Change in glycated albumin		during chemotherapy (about 1 year)
Secondary	Recurrence free survival (RFS)		from the Date of enrollment to the date of disease recurrence or date of any cause assessed upto 100 months