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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
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.
Hospital Clínic
Barcelona, Spain
RECRUITINGQuality of life score
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.
Time frame: 0, 28,and 35 days
Cancer quality of life score
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.
Time frame: 0, 28,and 35 days
Cancer-related fatigue
For cancer-related fatigue evaluation, 'The Functional Assessment of Cancer Therapy - Breast' (FACT-B) will be administered.
Time frame: 0, 28,and 35 days
Body composition
To measure fat mass and lean mass (in absolute values, kg, or relative valeus. %) the dual X-ray absorptiometry (DEXA) technique will be used.
Time frame: 0, 28,and 35 days
Bone density
To measure the bone density (g/cm\^2 or T score), the dual X-ray absorptiometry (DEXA) technique will be used.
Time frame: 0, 28,and 35 days
Cardiorespiratory fitness
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.
Time frame: 0, 28,and 35 days
Maximum isometric manual grip strength
Maximum isometric manual grip strength measured using a handgrip dynamometer.
Time frame: 0, 28,and 35 days
Upper body maximum strength
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.
Time frame: 0, 28,and 35 days
Lower body maximum strength
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.
Time frame: 0, 28,and 35 days
Shoulder range of motion
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.
Time frame: 0, 28,and 35 days
Relative oxyhemoglobin concentration ([02Hb]) in the microenvironment of the tumor
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).
Time frame: 1 and 27 days
Relative deoxyhemoglobin concentration ([HHb]) in the microenvironment of the tumor
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).
Time frame: 1 and 27 days
Oxygen saturation (StO2) in the microenvironment of the tumor
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).
Time frame: 1 and 27 days
Blood flow (BF) in the microenvironment of the tumor
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).
Time frame: 1 and 27 days
Height
As complementary anthropometric measurement, we will include height measured in cm
Time frame: 0, 28,and 35 days
Body mass
As complementary anthropometric measurement, we will include body mass in kg.
Time frame: 0, 28,and 35 days
Body mass index
Body mass index will be calculated following the formula BMI=body mass / height\^2.
Time frame: 0, 28,and 35 days
Wait circumference
As complementary anthropometric measurement, we will include waist circumference in cm.
Time frame: 0, 28,and 35 days
Anthropometric measurements
As complementary anthropometric measurement, we will include hip circumference in cm.
Time frame: 0, 28,and 35 days
Bioimpedance measurements
Water composition estimated by bioimpedance will be used to better estimate body composition
Time frame: 0, 28,and 35 days
Maximal heart rate
Maximal heart rate (HRmax) measured via a heart rate monitor synchronized with the gas analyzer during the incremental test.
Time frame: 0, 28,and 35 days
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