Prehabilitation Exercise Program in Breast Cancer: Effects on Quality of Life and Tumor Microenvironment (PEP_BC) (PEP_BC)

April 8, 2024 updated by: Albert Busquets Faciaben, Institut Nacional d'Educacio Fisica de Catalunya

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic
        • Contact:
        • Principal Investigator:
          • Albert Busquets, PhD
        • Principal Investigator:
          • Lucia Sagarra-Moreno, PhD
        • Sub-Investigator:
          • Esther Valera, MSc
        • Sub-Investigator:
          • Graciela Martínez-Pallí, MD
        • Sub-Investigator:
          • Raquel Sebio, PhD
        • Sub-Investigator:
          • Blai Ferrer-Uris, PhD
        • Sub-Investigator:
          • Turgut Durduran, PhD
        • Sub-Investigator:
          • Mireia Mora, MD
        • Sub-Investigator:
          • Eduard Mension, MD
        • Sub-Investigator:
          • Helena Castillo, MD
        • Sub-Investigator:
          • Rosa Angulo-Barroso, PhD
        • Sub-Investigator:
          • Alfredo Irurtia, PhD
        • Sub-Investigator:
          • Marta Carrasco-Marginet, PhD
        • Sub-Investigator:
          • Alex Cebrián-Ponce, MSc
        • Sub-Investigator:
          • Ferran Faixat
        • Sub-Investigator:
          • Quim Rosales
        • Sub-Investigator:
          • Raquel Martinez-Reviejo, MSc
        • Sub-Investigator:
          • Paula Bonay, BS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEP group
Breast cancer patients involved in a prehabilitation physical exercise program
Behavioral: Prehabilitation exercise program
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.
No Intervention: CON group
Breast cancer patients not involved in a prehabilitation physical exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life score
Time Frame: 0, 28,and 35 days
Quality of life will be assessed using the 'European Organisation for Research and Treatment of Cancer Quality ofLife Questionnaire' (EORTC QLQ-C30). This questionnaire has three different scales: (1) Global health status with 2 items scored from 1 to 7, (2) Functional scales with 15 items scored from 1 to 4, and (3) Symptom scales with 13 items scored from 1 to 4. All of the raw scores from the scales are transformed to values from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a healthy level of functioning, a high score for the global health status represents a high quality of life, but a high score for a symptom scale represents a high level of symptomatology.
0, 28,and 35 days
Cancer quality of life score
Time Frame: 0, 28,and 35 days
Cancer quality of life will be assessed using the 'European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer' (EORTC QLQ-BR23). This questionnaire has two different scales: (1) Symptoms scale with 15 items scored from 1 to 4, and (2) Functional scales with 8 items scored from 1 to 4. All of the raw scores from the scales are transformed to values from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a healthy level of functioning, a high score for the global health status represents a high quality of life, but a high score for a symptom scale represents a high level of symptomatology.
0, 28,and 35 days
Cancer-related fatigue
Time Frame: 0, 28,and 35 days
For cancer-related fatigue evaluation, 'The Functional Assessment of Cancer Therapy - Breast' (FACT-B) will be administered.
0, 28,and 35 days
Body composition
Time Frame: 0, 28,and 35 days
To measure fat mass and lean mass (in absolute values, kg, or relative valeus. %) the dual X-ray absorptiometry (DEXA) technique will be used.
0, 28,and 35 days
Bone density
Time Frame: 0, 28,and 35 days
To measure the bone density (g/cm^2 or T score), the dual X-ray absorptiometry (DEXA) technique will be used.
0, 28,and 35 days
Cardiorespiratory fitness
Time Frame: 0, 28,and 35 days
Maximal oxygen volume (VO2 max) determine from an incremental test that will be conducted on a cycle ergometer with a portable gas analyzer to measure oxygen consumption.
0, 28,and 35 days
Maximum isometric manual grip strength
Time Frame: 0, 28,and 35 days
Maximum isometric manual grip strength measured using a handgrip dynamometer.
0, 28,and 35 days
Upper body maximum strength
Time Frame: 0, 28,and 35 days
Upper body tests involve pushing a fixed barbell with arms parallel to the ground and elbows at 90º similarly to a bench press. A force sensor will record force exerted during the strength tests.
0, 28,and 35 days
Lower body maximum strength
Time Frame: 0, 28,and 35 days
Lower body tests include performing knee extensions from a seated position with the knee at 90º against an immovable piece. A force sensor will record force exerted during the strength tests.
0, 28,and 35 days
Shoulder range of motion
Time Frame: 0, 28,and 35 days
Mobility will be measured using inertial sensors (gyroscope from a mobile) and a custom-made software to assess the maximum angle of motion (in degrees) in the three plans of motion.
0, 28,and 35 days
Relative oxyhemoglobin concentration ([02Hb]) in the microenvironment of the tumor
Time Frame: 1 and 27 days
Vascularization and perfusion enhance in the microenvironment of the tumor will be expressed as a relative increase of oxyhemoglobin concentration ([02Hb]) measured by functional near-infrared spectroscopy (fNIRS).
1 and 27 days
Relative deoxyhemoglobin concentration ([HHb]) in the microenvironment of the tumor
Time Frame: 1 and 27 days
Vascularization and perfusion decrease in the microenvironment of the tumor will be expressed as a relative increase of deoxyhemoglobin concentration ([HHb]) measured by functional near-infrared spectroscopy (fNIRS).
1 and 27 days
Oxygen saturation (StO2) in the microenvironment of the tumor
Time Frame: 1 and 27 days
Vascularization and perfusion enhance in the microenvironment of the tumor will be expressed as a relative increase of Oxygen saturation (StO2) measured by functional near-infrared spectroscopy (fNIRS).
1 and 27 days
Blood flow (BF) in the microenvironment of the tumor
Time Frame: 1 and 27 days
Vascularization enhance in the microenvironment of the tumor will be expressed as a relative increase of blood flow index (BFI) measured by diffuse correlation optical spectroscopy (DCS).
1 and 27 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Height
Time Frame: 0, 28,and 35 days
As complementary anthropometric measurement, we will include height measured in cm
0, 28,and 35 days
Body mass
Time Frame: 0, 28,and 35 days
As complementary anthropometric measurement, we will include body mass in kg.
0, 28,and 35 days
Body mass index
Time Frame: 0, 28,and 35 days
Body mass index will be calculated following the formula BMI=body mass / height^2.
0, 28,and 35 days
Wait circumference
Time Frame: 0, 28,and 35 days
As complementary anthropometric measurement, we will include waist circumference in cm.
0, 28,and 35 days
Anthropometric measurements
Time Frame: 0, 28,and 35 days
As complementary anthropometric measurement, we will include hip circumference in cm.
0, 28,and 35 days
Bioimpedance measurements
Time Frame: 0, 28,and 35 days
Water composition estimated by bioimpedance will be used to better estimate body composition
0, 28,and 35 days
Maximal heart rate
Time Frame: 0, 28,and 35 days
Maximal heart rate (HRmax) measured via a heart rate monitor synchronized with the gas analyzer during the incremental test.
0, 28,and 35 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Nacional d'Educacio Fisica de Catalunya

Collaborators

Hospital Clinic of Barcelona
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Universidad San Jorge
ICFO - The Institute of Photonics Sciences

Investigators

  • Principal Investigator: Albert Busquets, PhD, Institut Nacional d'Educació Física de Catalunya
  • Principal Investigator: Lucia Sagarra-Romero, PhD, Universidad San Jorge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

March 29, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024 PARINEFC 00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After finishing the study, the data processed and anonymized will be available in B2share repositories (https://b2share.eudat.eu/) under the Creative Commons CC BY-NC-SA license.They will only be used for scientific purposes and after requesting permission from the authors and under the same conditions that we have established. The following data will not be made publicly available:

  • Personal data and other data that can be tracked to participants identity.
  • Data that compromises the protection of a partner(s) intellectual property.
  • The level of data made available will also be considered, for example, preprocessed data will not be provided unless there is a clear reason for doing so.
  • Datasets which cannot be shared because of legal and contractual reasons.

IPD Sharing Time Frame

After finishing the study

IPD Sharing Access Criteria

Once processing, quality control, organisation, analysis, and publication are complete, the data will be made accessible by deposition in open access repositories (https://b2share.eudat.eu).

Members of the research team will form a data access committee. This committee will oversee that openly accessible data respect ethical and data security aspects, including intellectual property requirements. The possibilities of accessing the data in the specialized repository will always be decided in consultation with our collaborators.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Prehabilitation exercise program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe