Viewing Study NCT06522971



Ignite Creation Date: 2024-10-26 @ 3:36 PM
Last Modification Date: 2024-10-26 @ 3:36 PM
Study NCT ID: NCT06522971
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: None
First Post: 2024-07-09

Brief Title: Effects of Physical Exercise on Response to Treatement in Breast Cancer
Sponsor: None
Organization: None

Study Overview

Official Title: Exploration of the Molecular Mechanisms Behind the Effects of Physical Exercise on Response to Neoadjuvant Chemotherapy in Breast Cancer Patients
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CancerBeat
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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None