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NCT Number: NCT06623903

Early Changes in Metabolic Health in Breast Cancer Patients Initiating Endocrine Therapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Oncology, Aarhus University Hosptial

Aarhus N, Central Jutland, 8200, Denmark

Location contact

Lærke S Nissen, BS.c., Research year student

CONTACT

[email protected]

(+45) 61 11 29 28

Signe Borgquist, Clinical Chair Professor, Ph.D

CONTACT

[email protected]

(+45) 91 16 72 94

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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. 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

  4. 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)

  5. Cholestrerol

    Time frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)

    A change in blood cholesterol compared to baseline

  6. Triglycerides

    Time frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)

    A change in triglycerides compared to baseline

  7. 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.

  8. 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

  9. 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)

Secondary outcomes

  1. Estrogen level

    Time frame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)

    Changes in circulating estrogen compared to baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Lærke S Nissen, BS.c., Research Year Student

CONTACT

[email protected]

(+45) 61 11 29 28

Signe Borgquist, Clinical Chair Professor, Ph.D

CONTACT

[email protected]

(+45) 91 16 72 94

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • Danish Cancer Society

Registry information

Official study title

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

Acronym: EMETA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 2, 2024
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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