Effects of Physical Exercise on Response to Treatement in Breast Cancer (CancerBeat)

September 3, 2025 updated by: Latvian Biomedical Research and Study Centre

Exploration of the Molecular Mechanisms Behind the Effects of Physical Exercise on Response to Neoadjuvant Chemotherapy in Breast Cancer Patients

The goal of this clinical trial is to learn how regular physical exercise affects breast cancer patients' response to standard neoadjuvant chemotherapy (NAC) and to gain an insight into the molecular mechanisms underlying the effects of exercise on cancer biology. of exercise-induced alterations in cancer gene expression and the immune tumor microenvironment. The main questions it aims to answer are:

  • Does a high-intensity interval training (HIIT) program during treatment improve patients' response to NAC and quality of life as compared to low level of physical activity during the treatment?
  • What are the differences in the residual tumor gene expression and tumor infiltrating immune cell profile between patients taking HIIT during the NAC and patients with low level of physical activity?
  • What are the roles of extracellular vesicles (EVs) in mediating the effects of exercise on cancer progression?

Patients in HIIT group will undergo a personalized HIIT program consisting of 3 training sessions per week for the whole duration of NAC, whereas patients from the control group (Ctrl) will be advised to maintain their usual level of physical activity during NAC. After the breast surgery, response to NAC will be assessed by Miller-Payne grading. Tumor and normal breast tissue specimens will be collected for RNA sequencing analysis. Blood samples will be collected before and immediately after the training for the analysis of RNA and protein cargo of circulating EVs.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

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

  • Latvia
    • Select One
      • Riga, Select One, Latvia, LV1067
        • Latvian Biomedical Research and Study centre

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

Description

Inclusion criteria:

  • Primary breast cancer; stage IIA-B, IIIA-C (TNM: T1-4, N0-3, M0) at diagnosis
  • Diagnosis established by core needle biopsy
  • Age 30-65 years
  • Prescribed doxorubicin/cyclophosphamide-based NAC
  • Oral and written consent

Exclusion criteria:

  • Cardiac pathologies
  • Pregnancy
  • Blood transfusion in the last six months
  • Another oncological disease
  • Previous chemotherapy, hormonal or X-ray treatment
  • Participation in another clinical trial
  • Currently performing more than 180 min of moderate to high intensity aerobic training per week

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-intensity interval training (HIIT)
High-intensity interval training during neoadjuvant chemotherapy
Behavioral: High-intensiy interval training
All participants undergo physical capacity tests before the onset of NAC and after the last course of NAC but before the breast cancer surgery. A treadmill protocol consisting of twenty-one 1-minute stages, with speed and/or grade increments at each stage, is used to obtain VO2 peak (the highest amount of oxygen consumed at peak exercise) data. The HIIT intervention consists of 2 to 3 exercise sessions per week for 6 months. The HIIT session starts with a 6-minute warm-up period at about 65-70% of maximal heart rate (HRmax) followed by 4 X 4-min high-intensity intervals (85%-95% of HRmax) combined with 3 min period of active recovery (55-70% of HRmax).
No Intervention: Low level of physical activity (CON)
Advised to maintain usual level of physical activity during neoadjuvant chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Miller-Payne grade
Time Frame: 6 months
Response to NAC assessed by histological examination of residual tumor at surgery using Miller-Payne grading from 1 to 5, where grade 1 means no response or some alterations to individual malignant cells but no reduction in overall cellularity, whereas grade 5 is a pathological complete response.
6 months
Gene expression profile
Time Frame: 12 months
Alterations in the tumor gene expression profile will be assessed by RNA sequencing of surgical tumor and normal breast tissue specimens
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RNA cargo of extracellular vesicles
Time Frame: Before intervention and after 6 months
Exercise-induced alterations in the RNA cargo of circulating extracellular vesicles will be studied by RNA sequencing
Before intervention and after 6 months
Protein cargo of extracellular vesicles
Time Frame: Before intervention and after 6 months
Exercise-induced alterations in the protein cargo of circulating extracellular vesicles will be studied by proteomic analysis
Before intervention and after 6 months
Number and phenotype of tumor-infiltrating immune cells
Time Frame: 12 months
Immunophenotyping of tumor-infiltrating immune cells will be performed by multiplex immunofluorescence in breast tumor tissue specimens
12 months
Global health-related quality of life
Time Frame: 6 months
Global health-related quality of life will be assessed by the European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30). All scales and single-item measures yield scores ranging from 0 to 100. A high score on a functional scale indicates superior functioning and a high score on the global health status/QoL scale indicates a high quality of life. Conversely, a high score on a symptom scale or item indicates a heightened level of health complaints and/ or presence of treatment side effects.
6 months
Breast cancer-related quality of life
Time Frame: 6 months
Breast cancer-related quality of life assessed by the European Organisation for Research and Treatment of Cancer Breast cancer module (EORTC QLQ-B23) questionnaire that includes 23 questions addressing disease symptoms, treatment side effects, body image, sexual functioning, and future perspectives. All scales and single-item measures yield scores ranging from 0 to 100.
6 months
VO2 peak
Time Frame: Before intervention and after 6 months
Oxygen peak consumption will be measured by UNCCRI treadmill protocol
Before intervention and after 6 months
30 sec sit-to-stand test
Time Frame: Before intervention and after 6 months
The number of sit- and stand-up movement repetitions achieved during 30 sec will be recorded
Before intervention and after 6 months
6-minute walk test
Time Frame: Before intervention and after 6 months
The test will be performed indoors on 30 m long testing course and length of walked distance will be measured
Before intervention and after 6 months

Collaborators and Investigators

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

Sponsor

Latvian Biomedical Research and Study Centre

Collaborators

Riga East Clinical University Hospital
Latvian Academy of Sport Education

Investigators

  • Principal Investigator: Aija Linē, PhD, Latvian Biomedical Research and Study centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 16, 2022

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFI_164

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

product manufactured in and exported from the U.S.

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.

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