Prehabilitation Exercise Program in Breast Cancer: Effects on Quality of Life and Tumor Microenvironment (PEP_BC)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Cancer quality of life score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Cancer quality of life score
时间窗: 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.
Bone density
时间窗: 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
时间窗: 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.
Relative oxyhemoglobin concentration ([02Hb]) in the microenvironment of the tumor
时间窗: 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).
Oxygen saturation (StO2) in the microenvironment of the tumor
时间窗: 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).
Cancer-related fatigue
时间窗: 0, 28,and 35 days
For cancer-related fatigue evaluation, 'The Functional Assessment of Cancer Therapy - Breast' (FACT-B) will be administered.
Body composition
时间窗: 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.
Lower body maximum strength
时间窗: 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.
Relative deoxyhemoglobin concentration ([HHb]) in the microenvironment of the tumor
时间窗: 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).
Quality of life score
时间窗: 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.
Maximum isometric manual grip strength
时间窗: 0, 28,and 35 days
Maximum isometric manual grip strength measured using a handgrip dynamometer.
Shoulder range of motion
时间窗: 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.
Upper body maximum strength
时间窗: 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.
Blood flow (BF) in the microenvironment of the tumor
时间窗: 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).
次要结局
- Body mass(0, 28,and 35 days)
- Body mass index(0, 28,and 35 days)
- Bioimpedance measurements(0, 28,and 35 days)
- Maximal heart rate(0, 28,and 35 days)
- Wait circumference(0, 28,and 35 days)
- Anthropometric measurements(0, 28,and 35 days)
- Height(0, 28,and 35 days)
研究者
Albert Busquets Faciaben
Principal Investigator
Institut Nacional d'Educacio Fisica de Catalunya