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NCT Number: NCT06976593

Muscle Oxygen Saturation and Functional Capacity 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.

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Key information

Age range

30 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Facultad de Mecina y Ciencias de la Salud

Badajoz, Spain

Location contact

Berta Caro Puértolas, PhD

PRINCIPAL_INVESTIGATOR

Mª Dolores Apolo Arenas, PhD

PRINCIPAL_INVESTIGATOR

Mª Dolores MD Apolo-Arenas, PhD

CONTACT

[email protected]

924489180

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

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)

    Time frame: During and immediately after functional assessment session

    0-10 points. 0: no perceived effort 10: maximum perceived effort

  5. Maximal inspiratory pressures (Pimax)

    Time frame: During and immediately after functional assessment session

  6. Pulmonary function (FEV1/FEV6 ratio using Vitalograph® COPD-6)

    Time frame: During and immediately after functional assessment session

  7. Quality of life (EORTC QLQ-C30) European Organisation for Research and Treatment of Cancer

    Time frame: During and immediately after functional assessment session

  8. Maximal expiratory pressures (Pemax)

    Time frame: During and immediately after functional assessment session

  9. Quality of life (BR23)

    Time frame: During and immediately after functional assessment session

Study contacts

Contact information is provided by the study sponsor or research team.

Mª Dolores MD Apolo-Arenas, PhD

CONTACT

[email protected]

924489180

Sponsors and collaborators

Lead sponsor

University of Extremadura

Other

Registry information

Official study title

Analysis of Muscle Oxygen Saturation and Functional Variables During Physical Performance Tests in Breast Cancer Survivors

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 16, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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