Muscle Oxygen Saturation and Functional Capacity in Breast Cancer Survivors

NCT ID: NCT06976593

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-05
• Study Completion Date: 2025-05-31

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.

Conditions

Breast Cancer Survivorship; Muscle Oxygenation; Near-infrared Spectroscopy; Exercise; Quality of Life; Functional Capacity; Hormonal Therapy

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

Hormonal Therapy Only

Participants who received only hormonal therapy following breast cancer treatment.

Functional Exercise Testing and Muscle Oxygen Saturation Measurement

Intervention Type: 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.

Hormonal Therapy + Chemotherapy

Participants who received both hormonal therapy and chemotherapy.

Functional Exercise Testing and Muscle Oxygen Saturation Measurement

Intervention Type: 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.

Interventions

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 during or after the tests.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Extremadura

OTHER

Sponsor Role: lead

Responsible Party

Alejandro Caña Pino

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Facultad de Mecina y Ciencias de la Salud

Badajoz, , Spain

Countries

Spain

Central Contacts

Mª Dolores MD Apolo-Arenas, PhD

Role: CONTACT

mdapolo@unex.es

924489180

Facility Contacts

Mª Dolores MD Apolo-Arenas, PhD

Role: primary

mdapolo@unex.es

924489180

Other Identifiers

050525

Identifier Type: -

Identifier Source: org_study_id