Trial Title:
Prehabilitation Exercise Program in Breast Cancer: Effects on Quality of Life and Tumor Microenvironment (PEP_BC)
NCT ID:
NCT06360809
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast cancer
physical exercise
tumor microenvironment
oxidative hemodynamics
near-infrared spectroscopy
diffuse correlation optical spectroscopy
prehabilitation therapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Prehabilitation exercise program
Description:
After the allocation, the intervention will consist of a prehabilitation program lasting
4 weeks. Each week, there will be three sessions, with one being face-to-face and the
other two being unsupervised sessions but with online video-support. Face-to-face
sessions will be organized in small groups, and each patient of the PEP group will have
an individualized plan based on data obtained during the initial assessment. Each session
will include a combination of strength training and moderate aerobic training in a
circuit format with movements especially involving the upper body.
Arm group label:
PEP group
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Be aged between 18 and 65 years.
- Have a diagnosis of hormone receptor-positive breast cancer (ER and PR).
- Have no medical contraindications that prevent them from participating in physical
exercise.
- Have four weeks period between diagnosis and surgery
Exclusion Criteria:
- Being diagnosed of another primary and/or secondary tumor or being in metastatic
stage.
- Presence of uncontrolled serious medical illness
- Presence of any medical, psychological or social problem that could seriously
interfere with the patient's participation in the study
- Those who have engaged in structured physical exercise in the last 6 months.
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Clínic
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Eduard Mension, MD
Email:
mension@clinic.cat
Investigator:
Last name:
Albert Busquets, PhD
Email:
Principal Investigator
Investigator:
Last name:
Lucia Sagarra-Moreno, PhD
Email:
Principal Investigator
Investigator:
Last name:
Esther Valera, MSc
Email:
Sub-Investigator
Investigator:
Last name:
Graciela Martínez-Pallí, MD
Email:
Sub-Investigator
Investigator:
Last name:
Raquel Sebio, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Blai Ferrer-Uris, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Turgut Durduran, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Mireia Mora, MD
Email:
Sub-Investigator
Investigator:
Last name:
Eduard Mension, MD
Email:
Sub-Investigator
Investigator:
Last name:
Helena Castillo, MD
Email:
Sub-Investigator
Investigator:
Last name:
Rosa Angulo-Barroso, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Alfredo Irurtia, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Marta Carrasco-Marginet, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Alex Cebrián-Ponce, MSc
Email:
Sub-Investigator
Investigator:
Last name:
Ferran Faixat
Email:
Sub-Investigator
Investigator:
Last name:
Quim Rosales
Email:
Sub-Investigator
Investigator:
Last name:
Raquel Martinez-Reviejo, MSc
Email:
Sub-Investigator
Investigator:
Last name:
Paula Bonay, BS
Email:
Sub-Investigator
Start date:
March 22, 2024
Completion date:
June 2025
Lead sponsor:
Agency:
Institut Nacional d'Educacio Fisica de Catalunya
Agency class:
Other
Collaborator:
Agency:
ICFO - The Institute of Photonics Sciences
Agency class:
Other
Collaborator:
Agency:
Hospital Clinic of Barcelona
Agency class:
Other
Collaborator:
Agency:
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Agency class:
Other
Collaborator:
Agency:
Universidad San Jorge
Agency class:
Other
Source:
Institut Nacional d'Educacio Fisica de Catalunya
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06360809
