Muscle Oxygen Saturation and Functional Capacity in Breast Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Functional Exercise Testing and Muscle Oxygen Saturation Measurement.
- Who it may be relevant to
- Registry conditions: Breast Cancer Survivorship, Muscle Oxygenation, Near-infrared Spectroscopy, Exercise. Basic parameters: 30 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Analysis of Muscle Oxygen Saturation and Functional Variables During Physical Performance Tests in Breast Cancer Survivors
Overview
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.
Detailed description
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.
Interventions
- 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 dur
Primary outcome measures
- Muscle oxygen saturation (%) [Time frame: Within a single assessment session (~1 hour)]
Secondary outcome measures (9)
- 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) [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]
Eligibility criteria
Inclusion criteria
- Women aged 30 to 70 years
- Clinical history of breast cancer treatment (at least 6 months prior)
- Completed primary cancer treatment
- Ability to perform physical tests
- Signed informed consent
Exclusion criteria
- Recurrence or metastasis
- Severe cardiopulmonary or musculoskeletal disease
- Neurological or cognitive limitations
- Ongoing oncological treatment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-crossover
Study locations
Spain · 1 center
- Facultad de Mecina y Ciencias de la Salud — Badajoz
Identifiers
NCT: NCT06976593 · 050525