Clinical trial NCT06623903: Early Changes in Metabolic Health in Breast Cancer Patients Initiating Endocrine Therapy
Official title: Early Breast Cancer, Endocrine Therapy Initiation, and Early Metabolic Health Changes: a Prospective Follow-up Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Early Breast Cancer
Metabolic Health
Estrogen Receptor Positive Breast Cancer
Keywords: Early breast cancer
Metabolic health
Endocrine therapy
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2024-10-02
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Metabolic health changes
timeFrame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
measure: Waist and hip circumference
timeFrame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
measure: Blood pressure
timeFrame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
measure: HbA1c
timeFrame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
measure: Cholestrerol
timeFrame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
measure: Triglycerides
timeFrame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
measure: LDL
timeFrame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
measure: HDL
timeFrame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
measure: Body Mass Index
timeFrame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
Secondary outcomes:
measure: Estrogen level
timeFrame: 3 months (from initiation of endocrine therapy to 3 month treatment follow-up)
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Oncology, Aarhus University Hosptial
state: Central Denmark Region
Study officials:
affiliation: Aarhus University Hospital
name: Signe Borgquist, Clinical Chair Professor, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: