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Trial Title:
Effects of Physical Exercise on Response to Treatement in Breast Cancer
NCT ID:
NCT06522971
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
High intensity interval training
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Basic Science
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
High-intensiy interval training
Description:
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).
Arm group label:
High-intensity interval training (HIIT)
Summary:
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
30 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Latvian Biomedical Research and Study centre
Address:
City:
Riga
Zip:
LV1067
Country:
Latvia
Start date:
August 16, 2022
Completion date:
December 2025
Lead sponsor:
Agency:
Latvian Biomedical Research and Study Centre
Agency class:
Other
Collaborator:
Agency:
Riga East Clinical University Hospital
Agency class:
Other
Collaborator:
Agency:
Latvian Academy of Sport Education
Agency class:
Other
Source:
Latvian Biomedical Research and Study Centre
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06522971
