Muscle Oxygen Saturation and Functional Capacity in Breast Cancer Survivors

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age30-70
SponsorUniversity of Extremadura

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Recurrence or metastasis

Severe cardiopulmonary or musculoskeletal disease

Neurological or cognitive limitations

Ongoing oncological treatment

Trial 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.

Trial design

Design model

Case-crossover

Time perspective

Prospective

Treatments tested in this trial

  • Functional Exercise Testing and Muscle Oxygen Saturation Measurement

    Diagnostic 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Hormonal Therapy Only1 intervention
Group B: Hormonal Therapy + Chemotherapy1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

Distance covered in the 6-Minute Walk Test (meters)

Time frame
During and immediately after functional assessment session
2

Number of repetitions in the 30-Second Sit-to-Stand Test

Time frame
During and immediately after functional assessment session
3

Maximal heart rate and recovery rate during treadmill test

Time frame
During and immediately after functional assessment session
4

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

Other outcomes

Sponsors and contacts

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