Clinical trial NCT06522971: Effects of Physical Exercise on Response to Treatement in Breast Cancer
Official title: Exploration of the Molecular Mechanisms Behind the Effects of Physical Exercise on Response to Neoadjuvant Chemotherapy in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: High intensity interval training
Lead sponsor: Latvian Biomedical Research and Study Centre
Sponsor class: OTHER_GOV
Collaborators: name: Riga East Clinical University Hospital
name: Latvian Academy of Sport Education
First posted: 2024-07-26
Enrollment: 55
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


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

Primary outcomes:
measure: Miller-Payne grade
timeFrame: 6 months
measure: Gene expression profile
timeFrame: 12 months
Secondary outcomes:
measure: RNA cargo of extracellular vesicles
timeFrame: Before intervention and after 6 months
measure: Protein cargo of extracellular vesicles
timeFrame: Before intervention and after 6 months
measure: Number and phenotype of tumor-infiltrating immune cells
timeFrame: 12 months
measure: Global health-related quality of life
timeFrame: 6 months
measure: Breast cancer-related quality of life
timeFrame: 6 months
measure: VO2 peak
timeFrame: Before intervention and after 6 months
measure: 30 sec sit-to-stand test
timeFrame: Before intervention and after 6 months
measure: 6-minute walk test
timeFrame: Before intervention and after 6 months
Other outcomes:
Locations:
city: Riga
country: Latvia
facility: Latvian Biomedical Research and Study centre
state: Select One
Study officials:
affiliation: Latvian Biomedical Research and Study Centre
name: Aija Linē, PhD
role: PRINCIPAL_INVESTIGATOR
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