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

October 1, 2024 updated by: Signe Borgquist, Aarhus University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Lærke S Nissen, BS.c., Research year student
  • Phone Number: (+45) 61 11 29 28
  • Email: laenis@rm.dk

Study Contact Backup

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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Metabolic health changes
Time Frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
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
Time Frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
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
Time Frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
A change in blood pressure compared to baseline
3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
HbA1c
Time Frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
A change in circulating levels of glycated hemoglobin (HbA1c)
3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
Cholestrerol
Time Frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
A change in blood cholesterol compared to baseline
3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
Triglycerides
Time Frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
A change in triglycerides compared to baseline
3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
LDL
Time Frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
A change in low-density lipoprotein (LDL) compared to baseline.
3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
HDL
Time Frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
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
Time Frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Estrogen level
Time Frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
Changes in circulating estrogen compared to baseline
3 months (from initiation of endocrine therapy to 3 month treatment follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aarhus University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Danish Cancer Society

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Signe Borgquist, Clinical Chair Professor, Ph.D, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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