Clinical trial NCT06976593: Muscle Oxygen Saturation and Functional Capacity in Breast Cancer Survivors
Official title: Analysis of Muscle Oxygen Saturation and Functional Variables During Physical Performance Tests in Breast Cancer Survivors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer Survivorship
Muscle Oxygenation
Near-infrared Spectroscopy
Exercise
Quality of Life
Functional Capacity
Hormonal Therapy
Lead sponsor: University of Extremadura
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

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

Primary outcomes:
measure: Muscle oxygen saturation (%)
timeFrame: Within a single assessment session (~1 hour)
Secondary outcomes:
measure: Distance covered in the 6-Minute Walk Test (meters)
timeFrame: During and immediately after functional assessment session
measure: Number of repetitions in the 30-Second Sit-to-Stand Test
timeFrame: During and immediately after functional assessment session
measure: Maximal heart rate and recovery rate during treadmill test
timeFrame: During and immediately after functional assessment session
measure: Lower limb fatigue and perceived exertion (Borg scale)
timeFrame: During and immediately after functional assessment session
measure: Maximal inspiratory pressures (Pimax)
timeFrame: During and immediately after functional assessment session
measure: Pulmonary function (FEV1/FEV6 ratio using Vitalograph® COPD-6)
timeFrame: During and immediately after functional assessment session
measure: Quality of life (EORTC QLQ-C30) European Organisation for Research and Treatment of Cancer
timeFrame: During and immediately after functional assessment session
measure: Maximal expiratory pressures (Pemax)
timeFrame: During and immediately after functional assessment session
measure: Quality of life (BR23)
timeFrame: During and immediately after functional assessment session
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: Facultad de Mecina y Ciencias de la Salud
Study officials:
References: