Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360809
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-29
Brief Title:
Prehabilitation Exercise Program in Breast Cancer Effects on Quality of Life and Tumor Microenvironment PEP_BC
Sponsor:
Institut Nacional dEducacio Fisica de Catalunya
Organization:
Institut Nacional dEducacio Fisica de Catalunya
Study Overview
Official Title:
Prehabilitation Exercise Program in Breast Cancer Effects on Quality of Life and Tumor Microenvironment PEP_BC
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEP_BC
Brief Summary:
To improve the health and quality of life of breast cancer BC patients researchers are focusing on prehabilitation strategies like physical exercise preparing patients both mentally and physically for clinical and surgical procedures potentially reducing complications Physical exercise is also recognized as pivotal in optimizing chemotherapy It can improve blood flow and oxygen supply in the microenvironment of the tumor MT potentially enhancing chemotherapy effectiveness Although previous research has shown the benefits of preoperative exercise combined with chemotherapy in various cancer types including BC further investigation is needed into the exact effects of prehabilitation exercise PE on MT physiology
This study aims to provide valuable insights into the potential benefits of PE for BC patients and its impact on the tumor microenvironment The hypothesis is that PE in BC patients will improve their quality of life reduce fatigue increase muscle mass decrease fat mass and enhance physical fitness Additionally beneficial acute hemodynamic changes particularly increased blood flow following PE sessions and hemodynamic adaptations involving higher levels of oxygenated hemoglobin increased blood flow greater oxygen saturation and a higher metabolic rate of oxygen are expected
The study will include 76 participants aged 18-65 years meeting specific criteria such as a diagnosis of hormone receptor-positive BC no medical contraindications for exercise no metastatic cancer and no structured exercise in the last six months These participants will be randomly assigned to a PE group or a control group The study will consist of three phases Phase 1 involves pre-intervention assessments Phase 2 includes a 4-week PE intervention with three weekly sessions and Phase 3 encompasses post-intervention and post-surgery assessments The 4-week PE intervention in Phase 2 will include strength and aerobic training Quality of life and fatigue assessments will use questionnaires and measurements will be made for fat mass lean mass bone density and cardiorespiratory fitness Strength measurements will be taken and shoulder mobility will be evaluated Hemodynamics of the MT will be assessed using a hybrid device combining Near-Infrared Spectroscopy and Diffuse Correlation Spectroscopy with ultrasound
This study aims to provide valuable insights into the potential benefits of PE for BC patients and its impact on the tumor microenvironment The hypothesis is that PE in BC patients will improve their quality of life reduce fatigue increase muscle mass decrease fat mass and enhance physical fitness Additionally beneficial acute hemodynamic changes particularly increased blood flow following PE sessions and hemodynamic adaptations involving higher levels of oxygenated hemoglobin increased blood flow greater oxygen saturation and a higher metabolic rate of oxygen are expected
The study will include 76 participants aged 18-65 years meeting specific criteria such as a diagnosis of hormone receptor-positive BC no medical contraindications for exercise no metastatic cancer and no structured exercise in the last six months These participants will be randomly assigned to a PE group or a control group The study will consist of three phases Phase 1 involves pre-intervention assessments Phase 2 includes a 4-week PE intervention with three weekly sessions and Phase 3 encompasses post-intervention and post-surgery assessments The 4-week PE intervention in Phase 2 will include strength and aerobic training Quality of life and fatigue assessments will use questionnaires and measurements will be made for fat mass lean mass bone density and cardiorespiratory fitness Strength measurements will be taken and shoulder mobility will be evaluated Hemodynamics of the MT will be assessed using a hybrid device combining Near-Infrared Spectroscopy and Diffuse Correlation Spectroscopy with ultrasound
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None