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NCT05107388 Clinical Trial

Continuous Glucose Monitoring Profile Description Under Alpelisib treAtment in Patients With Advanced bREast Cancer

Breast Cancer Clinical Trial

— AAREN  

Official title:
AAREN: Continuous Glucose Monitoring Profile Description Under Alpelisib treAtment in Patients With Advanced bREast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05107388
Other study ID # 2021/609
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2021
Est. completion date March 2024

Study information
Verified date October 2021
Source Centre Hospitalier Universitaire de Besancon
Contact Fatimata SARR SALL, PhD
Phone 033381219449
Email fatimata.sarr@chu-besancon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to describe the glycemic profile of postmenopausal women treated with alpelisib plus fulvestrant using a continuous blood sugar monitoring device (FreeStyle Libre Pro) over 14 days

Description:

AAREN is a monocentric prospective study monitoring glycemic profile in patients treated with alpelisib plus fulvestrant. Patients will wear a noninvasive glucose monitoring sensor, the Freestyle Libre Pro for a 14 day period. Forty patients will be enrolled.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date March 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Women suffering breast cancer and eligible to treatment with Alpelisib 2. Age =18 years 3. Menopausal women (for at least 24 months) 4. Informed Consent Form signed Exclusion Criteria: 1. Men 2. Pregnant ou child-bearing potential women

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• FreeStyle Libre Pro
Measurements of interstitial glucose variations with FreeStyle Libre Pro

Locations
Country Name City State
France CHU de Besançon Besançon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence rate of hyperglycemia In percentage, measured before breakfast and diner (fasting blood glucose).
Hyperglycemia defined as follows:
if diabetes de novo:
capillar or interstitial fasting blood glucose = 1,50 g/L,
OR postprandial interstitial glucose = 2 g/L
OR glucose monitoring indicator = 6,5%
if worsening pre-existing diabetes:
increased capillar or interstitial fasting blood glucose = 0,50 g/L compared to average fasting blood glucose at J-3, J-2 and J-1
AND postprandial interstitial glucose = + 1,00 g/L compared to average fasting blood glucose at J-3, J-2 et J-1 OR average blood glucose = +0,50 g/L		 Day 14
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