Breast CancerPEP_BCNCT06360809
Prehabilitation Exercise Program in Breast Cancer: Effects on Quality of Life and Tumor Microenvironment (PEP_BC)
A study testing Prehabilitation exercise program in people with Breast Cancer, run by Institut Nacional d'Educacio Fisica de Catalunya at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Prehabilitation exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSpain
- Study dates
- 22 Mar 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Lucia Sagarra-Romero, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínic
Barcelona, 08036
Eduard Mension, MD, mension@clinic.cat
Albert Busquets, PhD
About this study
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
- Being tested
- Prehabilitation exercise program
- Keywords
- breast cancer, physical exercise, tumor microenvironment, oxidative hemodynamics, near-infrared spectroscopy, diffuse correlation optical spectroscopy, prehabilitation therapy
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation exercise programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PEP group | Experimental | Breast cancer patients involved in a prehabilitation physical exercise program Receives: Behavioral: Prehabilitation exercise program |
| CON group | No intervention | Breast cancer patients not involved in a prehabilitation physical exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0, 28,and 35 days
Maximum isometric manual grip strength
Maximum isometric manual grip strength measured using a handgrip dynamometer.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 1 and 27 days
Secondary outcomes (7)
Height
As complementary anthropometric measurement, we will include height measured in cm
Measured: 0, 28,and 35 days
Body mass
As complementary anthropometric measurement, we will include body mass in kg.
Measured: 0, 28,and 35 days
Body mass index
Body mass index will be calculated following the formula BMI=body mass / height^2.
Measured: 0, 28,and 35 days
Wait circumference
As complementary anthropometric measurement, we will include waist circumference in cm.
Measured: 0, 28,and 35 days
Anthropometric measurements
As complementary anthropometric measurement, we will include hip circumference in cm.
Measured: 0, 28,and 35 days
Bioimpedance measurements
Water composition estimated by bioimpedance will be used to better estimate body composition
Measured: 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.
Measured: 0, 28,and 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start22 Mar 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Nacional d'Educacio Fisica de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- ICFO - The Institute of Photonics Sciences, Hospital Clinic of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universidad San Jorge
- Responsible party
- Principal investigator, Albert Busquets Faciaben, Institut Nacional d'Educacio Fisica de Catalunya
- Investigators
- Albert Busquets, PhD, Principal investigator, Institut Nacional d'Educació Física de CatalunyaLucia Sagarra-Romero, PhD, Principal investigator, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360809
- Sponsor's protocol ID
- 2024 PARINEFC 00001
- Acronym
- PEP_BC
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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: * Personal data and other data that can be tracked to participants identity. * Data that compromises the protection of a partner(s) intellectual property. * The level of data made available will also be considered, for example, preprocessed data will not be provided unless there is a clear reason for doing so. * Datasets which cannot be shared because of legal and contractual reasons.
Publications
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.
PubMed 32607943Lee 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.
PubMed 30919143Gillis C, Loiselle SE, Fiore JF Jr, Awasthi R, Wykes L, Liberman AS, Stein B, Charlebois P, Carli F. Prehabilitation with Whey Protein Supplementation on Perioperative Functional Exercise Capacity in Patients Undergoing Colorectal Resection for Cancer: A Pilot Double-Blinded Randomized Placebo-Controlled Trial. J Acad Nutr Diet. 2016 May;116(5):802-12. doi: 10.1016/j.jand.2015.06.007. Epub 2015 Jul 21.
PubMed 26208743Santa Mina D, Hilton WJ, Matthew AG, Awasthi R, Bousquet-Dion G, Alibhai SMH, Au D, Fleshner NE, Finelli A, Clarke H, Aprikian A, Tanguay S, Carli F. Prehabilitation for radical prostatectomy: A multicentre randomized controlled trial. Surg Oncol. 2018 Jun;27(2):289-298. doi: 10.1016/j.suronc.2018.05.010. Epub 2018 May 7.
PubMed 29937184Sebio Garcia R, Yanez Brage MI, Gimenez Moolhuyzen E, Granger CL, Denehy L. Functional and postoperative outcomes after preoperative exercise training in patients with lung cancer: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2016 Sep;23(3):486-97. doi: 10.1093/icvts/ivw152. Epub 2016 May 25.
PubMed 27226400Bozzetti F. Forcing the vicious circle: sarcopenia increases toxicity, decreases response to chemotherapy and worsens with chemotherapy. Ann Oncol. 2017 Sep 1;28(9):2107-2118. doi: 10.1093/annonc/mdx271.
PubMed 28911059Lipsett A, Barrett S, Haruna F, Mustian K, O'Donovan A. The impact of exercise during adjuvant radiotherapy for breast cancer on fatigue and quality of life: A systematic review and meta-analysis. Breast. 2017 Apr;32:144-155. doi: 10.1016/j.breast.2017.02.002. Epub 2017 Feb 9.
PubMed 28189100Travier N, Velthuis MJ, Steins Bisschop CN, van den Buijs B, Monninkhof EM, Backx F, Los M, Erdkamp F, Bloemendal HJ, Rodenhuis C, de Roos MA, Verhaar M, ten Bokkel Huinink D, van der Wall E, Peeters PH, May AM. Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial. BMC Med. 2015 Jun 8;13:121. doi: 10.1186/s12916-015-0362-z.
PubMed 26050790Florez Bedoya CA, Cardoso ACF, Parker N, Ngo-Huang A, Petzel MQ, Kim MP, Fogelman D, Romero SG, Wang H, Park M, Katz MHG, Schadler KL. Exercise during preoperative therapy increases tumor vascularity in pancreatic tumor patients. Sci Rep. 2019 Sep 27;9(1):13966. doi: 10.1038/s41598-019-49582-3.
PubMed 31562341Ashcraft KA, Warner AB, Jones LW, Dewhirst MW. Exercise as Adjunct Therapy in Cancer. Semin Radiat Oncol. 2019 Jan;29(1):16-24. doi: 10.1016/j.semradonc.2018.10.001.
PubMed 30573180Schumacher O, Galvao DA, Taaffe DR, Chee R, Spry N, Newton RU. Exercise modulation of tumour perfusion and hypoxia to improve radiotherapy response in prostate cancer. Prostate Cancer Prostatic Dis. 2021 Mar;24(1):1-14. doi: 10.1038/s41391-020-0245-z. Epub 2020 Jul 6.
PubMed 32632128Betof AS, Lascola CD, Weitzel D, Landon C, Scarbrough PM, Devi GR, Palmer G, Jones LW, Dewhirst MW. Modulation of murine breast tumor vascularity, hypoxia and chemotherapeutic response by exercise. J Natl Cancer Inst. 2015 Mar 16;107(5):djv040. doi: 10.1093/jnci/djv040. Print 2015 May.
PubMed 25780062Jones LW, Viglianti BL, Tashjian JA, Kothadia SM, Keir ST, Freedland SJ, Potter MQ, Moon EJ, Schroeder T, Herndon JE 2nd, Dewhirst MW. Effect of aerobic exercise on tumor physiology in an animal model of human breast cancer. J Appl Physiol (1985). 2010 Feb;108(2):343-8. doi: 10.1152/japplphysiol.00424.2009. Epub 2009 Dec 3.
PubMed 19959769Durduran T, Choe R, Yu G, Zhou C, Tchou JC, Czerniecki BJ, Yodh AG. Diffuse optical measurement of blood flow in breast tumors. Opt Lett. 2005 Nov 1;30(21):2915-7. doi: 10.1364/ol.30.002915.
PubMed 16279468Nioka S, Chance B. NIR spectroscopic detection of breast cancer. Technol Cancer Res Treat. 2005 Oct;4(5):497-512. doi: 10.1177/153303460500400504.
PubMed 16173821
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation Exercise Program in Breast Cancer: Effects on Quality of Life and Tumor Microenvironment (PEP_BC)
- ClinicalTrials.gov ID
- NCT06360809
- Acronym / sponsor ID
- PEP_BC / 2024 PARINEFC 00001
- Conditions
- Breast Cancer
- Keywords
- breast cancer, physical exercise, tumor microenvironment, oxidative hemodynamics, near-infrared spectroscopy, diffuse correlation optical spectroscopy, prehabilitation therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Institut Nacional d'Educacio Fisica de CatalunyaUniversity, hospital or other
- Collaborators
- ICFO - The Institute of Photonics Sciences, Hospital Clinic of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Universidad San Jorge
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEP group | Experimental | Behavioral: Prehabilitation exercise programBreast cancer patients involved in a prehabilitation physical exercise program |
| CON group | No intervention | –Breast cancer patients not involved in a prehabilitation physical exercise program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation exercise programAfter 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. | Behavioural | PEP group |
Primary outcome
Quality of life score
Time frame: 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
Time frame: 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
Time frame: 0, 28,and 35 days
For cancer-related fatigue evaluation, 'The Functional Assessment of Cancer Therapy - Breast' (FACT-B) will be administered.
Body composition
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 0, 28,and 35 days
Maximum isometric manual grip strength measured using a handgrip dynamometer.
Upper body maximum strength
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
7 secondary outcomes
Height
Time frame: 0, 28,and 35 days
Body mass
Time frame: 0, 28,and 35 days
Body mass index
Time frame: 0, 28,and 35 days
Wait circumference
Time frame: 0, 28,and 35 days
Anthropometric measurements
Time frame: 0, 28,and 35 days
Bioimpedance measurements
Time frame: 0, 28,and 35 days
Maximal heart rate
Time frame: 0, 28,and 35 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Background: PubMed 32607943Chong 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.
- Background: PubMed 30919143Lee 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.
- Background: PubMed 26208743Gillis C, Loiselle SE, Fiore JF Jr, Awasthi R, Wykes L, Liberman AS, Stein B, Charlebois P, Carli F. Prehabilitation with Whey Protein Supplementation on Perioperative Functional Exercise Capacity in Patients Undergoing Colorectal Resection for Cancer: A Pilot Double-Blinded Randomized Placebo-Controlled Trial. J Acad Nutr Diet. 2016 May;116(5):802-12. doi: 10.1016/j.jand.2015.06.007. Epub 2015 Jul 21.
- Background: PubMed 29937184Santa Mina D, Hilton WJ, Matthew AG, Awasthi R, Bousquet-Dion G, Alibhai SMH, Au D, Fleshner NE, Finelli A, Clarke H, Aprikian A, Tanguay S, Carli F. Prehabilitation for radical prostatectomy: A multicentre randomized controlled trial. Surg Oncol. 2018 Jun;27(2):289-298. doi: 10.1016/j.suronc.2018.05.010. Epub 2018 May 7.
- Background: PubMed 27226400Sebio Garcia R, Yanez Brage MI, Gimenez Moolhuyzen E, Granger CL, Denehy L. Functional and postoperative outcomes after preoperative exercise training in patients with lung cancer: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2016 Sep;23(3):486-97. doi: 10.1093/icvts/ivw152. Epub 2016 May 25.
- Background: PubMed 28911059Bozzetti F. Forcing the vicious circle: sarcopenia increases toxicity, decreases response to chemotherapy and worsens with chemotherapy. Ann Oncol. 2017 Sep 1;28(9):2107-2118. doi: 10.1093/annonc/mdx271.
- Background: PubMed 28189100Lipsett A, Barrett S, Haruna F, Mustian K, O'Donovan A. The impact of exercise during adjuvant radiotherapy for breast cancer on fatigue and quality of life: A systematic review and meta-analysis. Breast. 2017 Apr;32:144-155. doi: 10.1016/j.breast.2017.02.002. Epub 2017 Feb 9.
- Background: PubMed 26050790Travier N, Velthuis MJ, Steins Bisschop CN, van den Buijs B, Monninkhof EM, Backx F, Los M, Erdkamp F, Bloemendal HJ, Rodenhuis C, de Roos MA, Verhaar M, ten Bokkel Huinink D, van der Wall E, Peeters PH, May AM. Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial. BMC Med. 2015 Jun 8;13:121. doi: 10.1186/s12916-015-0362-z.
- Background: PubMed 31562341Florez Bedoya CA, Cardoso ACF, Parker N, Ngo-Huang A, Petzel MQ, Kim MP, Fogelman D, Romero SG, Wang H, Park M, Katz MHG, Schadler KL. Exercise during preoperative therapy increases tumor vascularity in pancreatic tumor patients. Sci Rep. 2019 Sep 27;9(1):13966. doi: 10.1038/s41598-019-49582-3.
- Background: PubMed 30573180Ashcraft KA, Warner AB, Jones LW, Dewhirst MW. Exercise as Adjunct Therapy in Cancer. Semin Radiat Oncol. 2019 Jan;29(1):16-24. doi: 10.1016/j.semradonc.2018.10.001.
- Background: PubMed 32632128Schumacher O, Galvao DA, Taaffe DR, Chee R, Spry N, Newton RU. Exercise modulation of tumour perfusion and hypoxia to improve radiotherapy response in prostate cancer. Prostate Cancer Prostatic Dis. 2021 Mar;24(1):1-14. doi: 10.1038/s41391-020-0245-z. Epub 2020 Jul 6.
- Background: PubMed 25780062Betof AS, Lascola CD, Weitzel D, Landon C, Scarbrough PM, Devi GR, Palmer G, Jones LW, Dewhirst MW. Modulation of murine breast tumor vascularity, hypoxia and chemotherapeutic response by exercise. J Natl Cancer Inst. 2015 Mar 16;107(5):djv040. doi: 10.1093/jnci/djv040. Print 2015 May.
- Individual participant dataSharing planned: Yes. 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: * Personal data and other data that can be tracked to participants identity. * Data that compromises the protection of a partner(s) intellectual property. * The level of data made available will also be considered, for example, preprocessed data will not be provided unless there is a clear reason for doing so. * Datasets which cannot be shared because of legal and contractual reasons.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucia Sagarra-Romero, PhD contact
Albert Busquets, PhD principal investigator
Institut Nacional d'Educació Física de Catalunya
Lucia Sagarra-Romero, PhD principal investigator
Universidad San Jorge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation exercise program in people with Breast Cancer, run by Institut Nacional d'Educacio Fisica de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Albert Busquets, PhD (934255445 ext. 213, albert.busquets@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life score (time frame: 0, 28,and 35 days). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06360809, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.