Breast Cancer
Conditions
Keywords
breast cancer, physical exercise, tumor microenvironment, oxidative hemodynamics, near-infrared spectroscopy, diffuse correlation optical spectroscopy, prehabilitation therapy
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.
Interventions
BEHAVIORALPrehabilitation 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.
Sponsors
ICFO - The Institute of Photonics Sciences
Hospital Clinic of Barcelona
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Universidad San Jorge
Institut Nacional d'Educacio Fisica de Catalunya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life score | 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. |
| Cancer quality of life score | 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. |
| Cancer-related fatigue | 0, 28,and 35 days | For cancer-related fatigue evaluation, 'The Functional Assessment of Cancer Therapy - Breast' (FACT-B) will be administered. |
| Body composition | 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. |
| Bone density | 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. |
| Cardiorespiratory fitness | 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. |
| Maximum isometric manual grip strength | 0, 28,and 35 days | Maximum isometric manual grip strength measured using a handgrip dynamometer. |
| Upper body maximum strength | 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. |
| Lower body maximum strength | 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. |
| Shoulder range of motion | 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. |
| Relative oxyhemoglobin concentration ([02Hb]) in the microenvironment of the tumor | 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). |
| Relative deoxyhemoglobin concentration ([HHb]) in the microenvironment of the tumor | 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). |
| Oxygen saturation (StO2) in the microenvironment of the tumor | 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). |
| Blood flow (BF) in the microenvironment of the tumor | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Height | 0, 28,and 35 days | As complementary anthropometric measurement, we will include height measured in cm |
| Body mass | 0, 28,and 35 days | As complementary anthropometric measurement, we will include body mass in kg. |
| Body mass index | 0, 28,and 35 days | Body mass index will be calculated following the formula BMI=body mass / height\^2. |
| Wait circumference | 0, 28,and 35 days | As complementary anthropometric measurement, we will include waist circumference in cm. |
| Anthropometric measurements | 0, 28,and 35 days | As complementary anthropometric measurement, we will include hip circumference in cm. |
| Bioimpedance measurements | 0, 28,and 35 days | Water composition estimated by bioimpedance will be used to better estimate body composition |
| Maximal heart rate | 0, 28,and 35 days | Maximal heart rate (HRmax) measured via a heart rate monitor synchronized with the gas analyzer during the incremental test. |
Countries
Spain
Contacts
Primary ContactAlbert Busquets, PhD
Backup ContactLucia Sagarra-Romero, PhD
Outcome results
None listed