Chemotherapy-induced Lipid Profile Changes in Women With Early Breast Cancer

May 24, 2025 updated by: Cancer center Stefan Kukura Hospital Michalovce

Detection of Changes in the Lipid Profile in Early-Stage Breast Cancer Patients Undergoing Neoadjuvant or Adjuvant Chemotherapy

Detection of changes in the lipid profile in early-stage breast cancer patients undergoing neoadjuvant or adjuvant chemotherapy with doxorubicin, cyclophosphamide, and paclitaxel.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite the development of highly effective antitumor therapies over the past two decades (e.g., targeted therapy, immunotherapy), chemotherapy regimens including anthracyclines, taxanes, and cyclophosphamide continue to represent a fundamental component of treatment algorithms for early breast cancer, particularly in human epidermal growth factor receptor 2 (HER2)-positive and triple-negative breast cancer (TNBC). While the cardiotoxicity of anthracyclines is well established and routinely monitored by echocardiography, changes in lipid profiles induced by cytotoxic chemotherapy have primarily been reported in retrospective studies with heterogeneous patient populations and measurement protocols.

This prospective, single-center study was designed to evaluate changes in lipid parameters in patients with early-stage breast cancer undergoing neoadjuvant or adjuvant chemotherapy with doxorubicin, cyclophosphamide, and paclitaxel.

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

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

Study Locations

  • Slovakia
      • Michalovce, Slovakia, 07101
        • Oncology Center, Štefan Kukura Hospital, Penta Hospitals, Michalovce

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult female patients with newly diagnosed, histologically confirmed early-stage invasive breast cancer (stages IB-IVA) assigned to receive standardized neoadjuvant or adjuvant chemotherapy with doxorubicin, cyclophosphamide, and paclitaxel, treated at a single center.

Description

Inclusion Criteria:

Female patients with newly diagnosed breast cancer, stage IB-IIIB, assigned to receive neoadjuvant or adjuvant chemotherapy.

Histologically confirmed invasive adenocarcinoma of the breast, including hormone receptor-positive, HER2-positive (human epidermal growth factor receptor 2), or triple-negative breast cancer.

Chemotherapy regimen based on doxorubicin, cyclophosphamide, and paclitaxel.

Completion of all planned neoadjuvant or adjuvant chemotherapy cycles.

Availability of complete lipid profile data at all required timepoints.

Exclusion Criteria Prior breast cancer treatment (surgery, chemotherapy, radiotherapy, or systemic therapy).

Ongoing or prior treatment with hypolipidemic (lipid-lowering) medications.

Incomplete chemotherapy regimen (interrupted or prematurely terminated cycles).

Presence of distant metastatic disease at diagnosis.

Missing or incomplete lipid profile data.

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
Intervention / Treatment
Female patients with early-stage breast cancer receiving neoadjuvant or adjuvant chemotherapy.
The cohort consists of adult female patients with newly diagnosed early-stage invasive breast cancer (stage IB-IIIB) scheduled to receive standardized neoadjuvant or adjuvant chemotherapy.
Other: Blood lipid monitoring in breast cancer patients during chemotherapy
This intervention is distinguished by its prospective design, enrollment of a clearly defined cohort of adult female patients with newly diagnosed early-stage breast cancer (stage IB-IIIB), administration of a uniform chemotherapy regimen (doxorubicin, cyclophosphamide, paclitaxel), and standardized monitoring of fasting lipid profiles at four precisely scheduled timepoints: pre-chemotherapy, pre-paclitaxel, post-paclitaxel, and three months post-chemotherapy completion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fasting lipid profile parameters (TC, TG, LDL-C, HDL-C) during and after chemotherapy
Time Frame: From enrollment (1-3 days prior to chemotherapy initiation) through three months after completion of chemotherapy.
Evaluation of dynamic changes in fasting serum levels of total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) at predefined timepoints during neoadjuvant or adjuvant chemotherapy and at three months after chemotherapy completion.
From enrollment (1-3 days prior to chemotherapy initiation) through three months after completion of chemotherapy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of lipid profile changes with menopausal status and body mass index (BMI)
Time Frame: From enrollment (1-3 days prior to chemotherapy initiation) through three months after completion of chemotherapy.
Assessment of the association between dynamic changes in fasting lipid parameters (TC, TG, LDL-C, HDL-C) and patients' menopausal status and body mass index (BMI) measured at baseline. The analysis aims to explore potential modifiers of chemotherapy-induced lipid alterations.
From enrollment (1-3 days prior to chemotherapy initiation) through three months after completion of chemotherapy.

Collaborators and Investigators

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

Sponsor

Cancer center Stefan Kukura Hospital Michalovce

Collaborators

Pavol Jozef Safarik University

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 (Actual)

March 5, 2023

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

April 27, 2025

First Submitted That Met QC Criteria

April 27, 2025

First Posted (Actual)

May 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 24, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONKOMi-Breast cancer study-23

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

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.

Clinical Trials on Breast Neoplasms

Clinical Trials on Blood lipid monitoring in breast cancer patients during chemotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe