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

NCT06360809 | Recruiting

• 1 other identifier: 2024 PARINEFC 00001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; physical exercise; tumor microenvironment; oxidative hemodynamics; near-infrared spectroscopy; diffuse correlation optical spectroscopy; prehabilitation therapy

Outcome Measures

Primary Outcomes (14)

• 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

• 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

Secondary Outcomes (7)

• Height

  0, 28,and 35 days

• Body mass

  0, 28,and 35 days

• Body mass index

  0, 28,and 35 days

• Wait circumference

  0, 28,and 35 days

• Anthropometric measurements

  0, 28,and 35 days

Study Arms (2)

PEP group

EXPERIMENTAL

Breast cancer patients involved in a prehabilitation physical exercise program

Behavioral: Prehabilitation exercise program

CON group

NO INTERVENTION

Breast cancer patients not involved in a prehabilitation physical exercise program

Interventions

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.

PEP group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Nacional d'Educacio Fisica de Catalunya: lead
• ICFO - The Institute of Photonics Sciences: collaborator
• Hospital Clinic of Barcelona: collaborator
• Institut d'Investigacions Biomèdiques August Pi i Sunyer: collaborator
• Universidad San Jorge: collaborator

Study Sites (1)

Hospital Clínic

Barcelona, 08036, Spain

RECRUITING

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MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Albert Busquets, PhD

  Institut Nacional d'Educació Física de Catalunya

  PRINCIPAL INVESTIGATOR

• Lucia Sagarra-Romero, PhD

  Universidad San Jorge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Albert Busquets, PhD

CONTACT

934255445; albert.busquets@gencat.cat

Lucia Sagarra-Romero, PhD

CONTACT

lsagarra@usj.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 11, 2024
• Study Start: March 22, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After finishing the study
• Access Criteria: 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.

Locations

ES (1)