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

NCT ID: NCT06623903

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-07-31

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.

Conditions

Early Breast Cancer; Metabolic Health; Estrogen Receptor Positive Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Early breast cancer patients initiating endocrine therapy

Patients with estrogen receptor-positive breast cancer initiating adjuvant endocrine therapy (either tamoxifen or aromatase inhibitors).

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danish Cancer Society

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Signe Borgquist

Chair Professor, Senior Consultant, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Signe Borgquist, Clinical Chair Professor, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Department of Oncology, Aarhus University Hosptial

Aarhus N, Central Jutland, Denmark

Countries

Denmark

Central Contacts

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

Role: CONTACT

laenis@rm.dk

(+45) 61 11 29 28

Signe Borgquist, Clinical Chair Professor, Ph.D

Role: CONTACT

Signe.borgquist@auh.rm.dk

(+45) 91 16 72 94

Facility Contacts

Signe Borgquist, Clinical Chair Professor, Ph.D

Role: primary

Signe.borgquist@auh.rm.dk

(+45) 91 16 72 94

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

Role: backup

laenis@rm.dk

(+45) 61 11 29 28

Other Identifiers

09-2247

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1-10-72-122-24

Identifier Type: -

Identifier Source: org_study_id