Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623903
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Early Changes in Metabolic Health in Breast Cancer Patients Initiating Endocrine Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Early Breast Cancer Endocrine Therapy Initiation and Early Metabolic Health Changes a Prospective Follow-up Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMETA
Brief Summary:
This clinical trial aims to investigate early metabolic health changes in early breast cancer patients that initiate antihormone therapy Furthermore how these changes are affected by estrogen level treatment type and patient characteristics The hypothesis is that initiation of antihormone therapy for early breast cancer patients is associated with an early deterioration in metabolic health after 3 months This includes increased BMI Body Mass Index waist- and hip circumference blood pressure blood sugars and lipids compared to when the patients initiate antihormone therapy Concurrently estradiol levels are expected to decrease An estimated 112 patients initiating antihormone therapy at the Dept of Oncology Aarhus University Hospital AUH will be included in the study over 6 months from autumn 2024 Patients will have a metabolic screening on the day of initiating antihormone therapy and at 3-month antihormone treatment follow-up The two metabolic screenings each consists of biometric measurements and a blood sample
Detailed Description:
Metabolic health closely tied to overweight and type 2 diabetes significantly influences disease risks notably breast cancer With over 25 billion overweight adults globally the prevalence of associated health concerns is escalating Breast cancer the leading cause of female cancer-related mortality is intricately linked to metabolic factors including overweight and diabetes particularly affecting estrogen receptor-positive tumors Conversely endocrine therapy as breast cancer treatment can exacerbate metabolic issues increasing weight gain and the risk of type 2 diabetes Despite its efficacy in reducing recurrence risk endocrine therapy is associated with adverse metabolic effects including elevated cholesterol levels Estrogen pivotal in metabolic homeostasis remains poorly understood in the context of endocrine therapy and metabolic disruptions This prospective study aims to elucidate this relationship focusing on the initiation of endocrine therapy metabolic health and estradiol levels among early-stage breast cancer patients Early breast cancer patients initiating endocrine therapy at Aarhus University Hospital from autumn 2024 and six months ahead will be extended an invitation for study participation with immediate measurements Metabolic health will be analyzed through weight hip and waist circumference measurements blood sugar cholesterol and estrogen at baseline and 3-month follow-up Thorough data collection including demographics treatment modalities and cancer characteristics ensures a comprehensive understanding of this complex interplay With 112 projected participants this study aims to shed light on the intricate connections between endocrine therapy patient characteristics and metabolic health changes Through this comprehensive approach the investigators aim to enhance patient care and understanding of managing metabolic health alongside breast cancer treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None