An observational study in Breast Cancer Survivorship, Muscle Oxygenation and Near-infrared Spectroscopy, sponsored by University of Extremadura. Not yet recruiting at 1 site in Spain. Open to female participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by University of Extremadura · Observational
This cross-sectional observational study aims to assess muscle oxygen saturation (SmO2) in the intercostal, quadriceps, and triceps surae muscles using near-infrared spectroscopy (NIRS) during functional exercise tests in breast cancer survivors. Participants will be grouped based on their previous cancer treatment: hormonal therapy only or hormonal therapy combined with chemotherapy. Functional performance will be evaluated through the 6-Minute Walk Test, 30-Second Sit-to-Stand Test, and a submaximal treadmill test. The study will analyze differences in muscle oxygenation and performance between groups and explore associations with other functional and clinical parameters.
This study focuses on evaluating muscle oxygen saturation and physical performance in women who have survived breast cancer. Cancer treatments such as chemotherapy and hormonal therapy can lead to systemic effects, including muscular deconditioning, fatigue, and reduced cardiorespiratory capacity. Near-infrared spectroscopy (NIRS) offers a non-invasive means of assessing SmO2 in real-time, providing insight into oxygen delivery and utilization during exercise.
Participants will undergo three functional tests: the 6-Minute Walk Test, the 30-Second Sit-to-Stand Test, and a submaximal treadmill test. Muscle oxygenation will be measured in three key muscle groups before, during, and after each task. Additional outcomes include functional test performance, respiratory strength, pulmonary function, fatigue perception, and quality of life questionnaires. This study will explore whether prior cancer treatment protocols affect muscle oxygenation and physical function differently, and may inform future rehabilitation strategies tailored to breast cancer survivors.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's planned enrollment of 30 is below the median of 98 across 1,235 observational studies indexed under Motor Activity.
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The study population consists of women aged 30 to 70 years who have completed treatment for breast cancer. Participants are recruited from outpatient oncology clinics and cancer survivor support groups in the region of Extremadura, Spain. All participants are categorized into two groups based on their treatment history: those who received hormonal therapy only and those who received both hormonal therapy and chemotherapy. All subjects must be able to perform physical tests and attend a single evaluation session.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who received only hormonal therapy following breast cancer treatment.
Diagnostic Test: Functional Exercise Testing and Muscle Oxygen Saturation Measurement
Participants who received both hormonal therapy and chemotherapy.
Diagnostic Test: Functional Exercise Testing and Muscle Oxygen Saturation Measurement
Participants will complete three physical performance tests: (1) the 6-Minute Walk Test (6MWT), (2) the 30-Second Sit-to-Stand Test, and (3) a submaximal treadmill test. Muscle oxygen saturation (SmO2) will be continuously monitored during the tests using near-infrared spectroscopy (NIRS) devices placed on the intercostal, quadriceps, and triceps surae muscles. Additional variables such as heart rate, perceived exertion, respiratory pressures, pulmonary function, and fatigue will be assessed during or after the tests.
Muscle oxygen saturation (%)
Measured via NIRS in intercostal, quadriceps, and triceps surae muscles during three functional tests (6MWT, 30CST, treadmill)
Time frame: Within a single assessment session (~1 hour)
Distance covered in the 6-Minute Walk Test (meters)
Time frame: During and immediately after functional assessment session
Number of repetitions in the 30-Second Sit-to-Stand Test
Time frame: During and immediately after functional assessment session
Maximal heart rate and recovery rate during treadmill test
Time frame: During and immediately after functional assessment session
Lower limb fatigue and perceived exertion (Borg scale)
0-10 points. 0: no perceived effort 10: maximum perceived effort
Time frame: During and immediately after functional assessment session
Maximal inspiratory pressures (Pimax)
Time frame: During and immediately after functional assessment session
Pulmonary function (FEV1/FEV6 ratio using Vitalograph® COPD-6)
Time frame: During and immediately after functional assessment session
Quality of life (EORTC QLQ-C30) European Organisation for Research and Treatment of Cancer
Time frame: During and immediately after functional assessment session
Maximal expiratory pressures (Pemax)
Time frame: During and immediately after functional assessment session
Quality of life (BR23)
Time frame: During and immediately after functional assessment session
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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University of Extremadura