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

Breast Cancer Clinical Trial

— PEP_BC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06360809
• Other study ID #: 2024 PARINEFC 00001
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2024
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Institut Nacional d'Educacio Fisica de Catalunya
• Contact: Albert Busquets, PhD
• Phone: 934255445
• Email: albert.busquets[@]gencat.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Clínic	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
Institut Nacional d'Educacio Fisica de Catalunya	Hospital Clinic of Barcelona, ICFO - The Institute of Photonics Sciences, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universidad San Jorge

Country where clinical trial is conducted

Spain, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Maximum isometric manual grip strength	Maximum isometric manual grip strength measured using a handgrip dynamometer.	0, 28,and 35 days
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	Height	As complementary anthropometric measurement, we will include height measured in cm	0, 28,and 35 days
Secondary	Body mass	As complementary anthropometric measurement, we will include body mass in kg.	0, 28,and 35 days
Secondary	Body mass index	Body mass index will be calculated following the formula BMI=body mass / height^2.	0, 28,and 35 days
Secondary	Wait circumference	As complementary anthropometric measurement, we will include waist circumference in cm.	0, 28,and 35 days
Secondary	Anthropometric measurements	As complementary anthropometric measurement, we will include hip circumference in cm.	0, 28,and 35 days
Secondary	Bioimpedance measurements	Water composition estimated by bioimpedance will be used to better estimate body composition	0, 28,and 35 days
Secondary	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