Breast Cancer SurvivorshipNCT06976593
Muscle Oxygen Saturation and Functional Capacity in Breast Cancer Survivors
An observational study of Breast Cancer Survivorship and Muscle Oxygenation, run by University of Extremadura at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Breast Cancer Survivorship, Muscle Oxygenation, Near-infrared Spectroscopy
- What is being tested?
- Functional Exercise Testing and Muscle Oxygen Saturation Measurement
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 5 May 2025to 31 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Recurrence or metastasis
- Severe cardiopulmonary or musculoskeletal disease
- Neurological or cognitive limitations
- Ongoing oncological treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Facultad de Mecina y Ciencias de la Salud
Badajoz
Mª Dolores MD Apolo-Arenas, PhD, 924489180, mdapolo@unex.es
Berta Caro Puértolas, PhD
About this study
Official title: Analysis of Muscle Oxygen Saturation and Functional Variables During Physical Performance Tests in Breast Cancer Survivors
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.
Read the 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.
- Conditions
- Breast Cancer Survivorship, Muscle Oxygenation, Near-infrared Spectroscopy, Exercise, Quality of Life, Functional Capacity
- Being tested
- Functional Exercise Testing and Muscle Oxygen Saturation Measurement
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Exercise Testing and Muscle Oxygen Saturation MeasurementDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Hormonal Therapy Only | Participants who received only hormonal therapy following breast cancer treatment. Receives: Diagnostic Test: Functional Exercise Testing and Muscle Oxygen Saturation Measurement | |
| Hormonal Therapy + Chemotherapy | Participants who received both hormonal therapy and chemotherapy. Receives: Diagnostic Test: Functional Exercise Testing and Muscle Oxygen Saturation Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle oxygen saturation (%)
Measured via NIRS in intercostal, quadriceps, and triceps surae muscles during three functional tests (6MWT, 30CST, treadmill)
Measured: Within a single assessment session (~1 hour)
Secondary outcomes (9)
Distance covered in the 6-Minute Walk Test (meters)
Measured: During and immediately after functional assessment session
Number of repetitions in the 30-Second Sit-to-Stand Test
Measured: During and immediately after functional assessment session
Maximal heart rate and recovery rate during treadmill test
Measured: 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
Measured: During and immediately after functional assessment session
Maximal inspiratory pressures (Pimax)
Measured: During and immediately after functional assessment session
Pulmonary function (FEV1/FEV6 ratio using Vitalograph® COPD-6)
Measured: During and immediately after functional assessment session
Quality of life (EORTC QLQ-C30) European Organisation for Research and Treatment of Cancer
Measured: During and immediately after functional assessment session
Maximal expiratory pressures (Pemax)
Measured: During and immediately after functional assessment session
Quality of life (BR23)
Measured: During and immediately after functional assessment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start5 May 2025 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorshipStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Caña Pino, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976593
- Sponsor's protocol ID
- 050525
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Muscle Oxygen Saturation and Functional Variables During Physical Performance Tests in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT06976593
- Acronym / sponsor ID
- 050525
- Conditions
- Breast Cancer Survivorship, Muscle Oxygenation, Near-infrared Spectroscopy, Exercise, Quality of Life, Functional Capacity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 5 May 2025 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 16 May 2025 (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.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hormonal Therapy Only | – | Diagnostic Test: Functional Exercise Testing and Muscle Oxygen Saturation MeasurementParticipants who received only hormonal therapy following breast cancer treatment. |
| Hormonal Therapy + Chemotherapy | – | Diagnostic Test: Functional Exercise Testing and Muscle Oxygen Saturation MeasurementParticipants who received both hormonal therapy and chemotherapy. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Recurrence or metastasis
- Severe cardiopulmonary or musculoskeletal disease
- Neurological or cognitive limitations
- Ongoing oncological treatment
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 |
|---|---|---|
| Functional Exercise Testing and Muscle Oxygen Saturation MeasurementParticipants 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. | Diagnostic test | Hormonal Therapy + Chemotherapy, Hormonal Therapy Only |
Primary outcome
Muscle oxygen saturation (%)
Time frame: Within a single assessment session (~1 hour)
Measured via NIRS in intercostal, quadriceps, and triceps surae muscles during three functional tests (6MWT, 30CST, treadmill)
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Survivorship and Muscle Oxygenation, run by University of Extremadura 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 5 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: opening soon, as of the sponsor's last update on 16 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mª Dolores MD Apolo-Arenas, PhD (924489180, mdapolo@unex.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle oxygen saturation (%) (time frame: Within a single assessment session (~1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2025.