Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06522971

Effects of Physical Exercise on Response to Treatement in Breast Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

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

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Latvian Biomedical Research and Study centre

Riga, Select One, LV1067, Latvia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-intensiy interval training

Behavioral

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).

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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. VO2 peak

    Time frame: Before intervention and after 6 months

    Oxygen peak consumption will be measured by UNCCRI treadmill protocol

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Latvian Biomedical Research and Study Centre

Other Gov

Collaborators

  • Latvian Academy of Sport Education
  • Riga East Clinical University Hospital

Registry information

Official study title

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

Acronym: CancerBeat

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jul 26, 2024
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.