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

NCT06623903 | Not Yet Recruiting DMC

• 2 other identifiers: 1-10-72-122-2409-2247
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Early breast cancer; Metabolic health; Endocrine therapy

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (1)

• Estrogen level

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

Study Arms (1)

Early breast cancer patients initiating endocrine therapy

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Danish Cancer Society: collaborator

Study Sites (1)

Department of Oncology, Aarhus University Hosptial

Aarhus N, Central Jutland, 8200, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

two blood samples analyzed for HbA1c, plasma glucose, hemoglobin, total cholesterol, triglycerides, LDL, HDL, and circulating estradiol.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Signe Borgquist, Clinical Chair Professor, Ph.D

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

(+45) 61 11 29 28; laenis@rm.dk

Signe Borgquist, Clinical Chair Professor, Ph.D

CONTACT

(+45) 91 16 72 94; Signe.borgquist@auh.rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor, Senior Consultant, PhD

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 2, 2024
• Study Start: November 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)