Early Changes in Metabolic Health in Breast Cancer Patients Initiating Endocrine Therapy (EMETA)

Early Breast Cancer, Endocrine Therapy Initiation, and Early Metabolic Health Changes: a Prospective Follow-up Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Early Breast Cancer; Estrogen Receptor Positive Breast Cancer; Metabolic Health

Detailed Description

Metabolic health, closely tied to overweight and type 2 diabetes, significantly influences disease risks, notably breast cancer. With over 2.5 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 Type: Observational
• Enrollment (Estimated): 112

Contacts and Locations

• Study Contact: Name: Lærke S Nissen, BS.c., Research year student; Phone Number: (+45) 61 11 29 28; Email: laenis@rm.dk
• Study Contact Backup: Name: Signe Borgquist, Clinical Chair Professor, Ph.D; Phone Number: (+45) 91 16 72 94; Email: Signe.borgquist@auh.rm.dk

Study Locations

• Denmark
  • Central Denmark Region
    • Aarhus N, Central Denmark Region, Denmark, 8200
      • Department of Oncology, Aarhus University Hosptial
      • Contact: Lærke S Nissen, BS.c., Research year student; Phone Number: (+45) 61 11 29 28; Email: laenis@rm.dk
      • Contact: Signe Borgquist, Clinical Chair Professor, Ph.D; Phone Number: (+45) 91 16 72 94; Email: Signe.borgquist@auh.rm.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Early breast cancer patients consulted at Dept. of Oncology Aarhus University Hospital from autumn 2024 and 6 months ahead regarding adjuvant treatment.

Description

Inclusion Criteria:

• Age ≥18 years
• Invasive ER+ breast cancer
• No diabetes treatment
• Planned for initiation of any adjuvant endocrine therapy.

Exclusion Criteria:

• Pregnancy or lactation,
• Psychological, familial, sociological, or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Early breast cancer patients initiating endocrine therapy; Patients with estrogen receptor-positive breast cancer initiating adjuvant endocrine therapy (either tamoxifen or aromatase inhibitors).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic health changes	A change (deterioration or improvement) in metabolic health compared to baseline. Defined by a change in at least one of the below mentioned parameters.	3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
Waist and hip circumference	A change in waist- and hip circumference compared to baseline	3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
Blood pressure	A change in blood pressure compared to baseline	3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
HbA1c	A change in circulating levels of glycated hemoglobin (HbA1c)	3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
Cholestrerol	A change in blood cholesterol compared to baseline	3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
Triglycerides	A change in triglycerides compared to baseline	3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
LDL	A change in low-density lipoprotein (LDL) compared to baseline.	3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
HDL	A change in and high-density lipoprotein (HDL) compared to baseline	3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
Body Mass Index	A change in Body Mass Index (Height and weight combined, kg/m2)	3 months (from initiation of endocrine therapy to 3 month treatment follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estrogen level	Changes in circulating estrogen compared to baseline	3 months (from initiation of endocrine therapy to 3 month treatment follow-up)

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Danish Cancer Society
• Investigators: Principal Investigator: Signe Borgquist, Clinical Chair Professor, Ph.D, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Metabolic health; Endocrine therapy; Early breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 1-10-72-122-24; 09-2247 (Other Grant/Funding Number: The Danish Cancer Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No