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| Name | Class |
|---|---|
| ICFO - The Institute of Photonics Sciences | UNKNOWN |
| Hospital Clinic of Barcelona | OTHER |
| Institut d'Investigacions Biomèdiques August Pi i Sunyer | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEP group | Experimental | Breast cancer patients involved in a prehabilitation physical exercise program |
|
| CON group | No Intervention | Breast cancer patients not involved in a prehabilitation physical exercise program |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation exercise program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality 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. | 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. | 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. | 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. | 0, 28,and 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| Height | As complementary anthropometric measurement, we will include height measured in cm | 0, 28,and 35 days |
| Body mass | As complementary anthropometric measurement, we will include body mass in kg. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Albert Busquets, PhD | Contact | 934255445 | 213 | albert.busquets@gencat.cat |
| Lucia Sagarra-Romero, PhD | Contact | lsagarra@usj.es |
| Name | Affiliation | Role |
|---|---|---|
| Albert Busquets, PhD | Institut Nacional d'Educació FÃsica de Catalunya | Principal Investigator |
| Lucia Sagarra-Romero, PhD | Universidad San Jorge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClÃnic | Recruiting | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32607943 | Background | Chong F, Wang Y, Song M, Sun Q, Xie W, Song C. Sedentary behavior and risk of breast cancer: a dose-response meta-analysis from prospective studies. Breast Cancer. 2021 Jan;28(1):48-59. doi: 10.1007/s12282-020-01126-8. Epub 2020 Jun 30. | |
| 30919143 | Background | Lee K, Kruper L, Dieli-Conwright CM, Mortimer JE. The Impact of Obesity on Breast Cancer Diagnosis and Treatment. Curr Oncol Rep. 2019 Mar 27;21(5):41. doi: 10.1007/s11912-019-0787-1. |
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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:
After finishing the study
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.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Universidad San Jorge |
| OTHER |
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|
| Bone density | 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 | 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 | Maximum isometric manual grip strength measured using a handgrip dynamometer. | 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. | 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. | 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. | 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). | 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). | 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). | 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). | 1 and 27 days |
| 0, 28,and 35 days |
| Body mass index | Body mass index will be calculated following the formula BMI=body mass / height^2. | 0, 28,and 35 days |
| Wait circumference | As complementary anthropometric measurement, we will include waist circumference in cm. | 0, 28,and 35 days |
| Anthropometric measurements | As complementary anthropometric measurement, we will include hip circumference in cm. | 0, 28,and 35 days |
| Bioimpedance measurements | Water composition estimated by bioimpedance will be used to better estimate body composition | 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. | 0, 28,and 35 days |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |