Muscle Oxygen Saturation and Functional Capacity in Breast Cancer Survivors

NCT06976593 | Not Yet Recruiting

• 1 other identifier: 050525
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Muscle oxygen saturation (%)

  Measured via NIRS in intercostal, quadriceps, and triceps surae muscles during three functional tests (6MWT, 30CST, treadmill)

  Within a single assessment session (~1 hour)

Secondary Outcomes (9)

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

  During and immediately after functional assessment session

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

  During and immediately after functional assessment session

• Maximal heart rate and recovery rate during treadmill test

  During and immediately after functional assessment session

• Lower limb fatigue and perceived exertion (Borg scale)

  During and immediately after functional assessment session

• Maximal inspiratory pressures (Pimax)

  During and immediately after functional assessment session

Study Arms (2)

Hormonal Therapy Only

Participants who received only hormonal therapy following breast cancer treatment.

Diagnostic Test: Functional Exercise Testing and Muscle Oxygen Saturation Measurement

Hormonal Therapy + Chemotherapy

Participants who received both hormonal therapy and chemotherapy.

Diagnostic Test: Functional Exercise Testing and Muscle Oxygen Saturation Measurement

Interventions

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.

Hormonal Therapy + Chemotherapy; Hormonal Therapy Only

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Recurrence or metastasis
• Severe cardiopulmonary or musculoskeletal disease
• Neurological or cognitive limitations
• Ongoing oncological treatment

Sponsors & Collaborators

• University of Extremadura: lead

Study Sites (1)

Facultad de Mecina y Ciencias de la Salud

Badajoz, Spain

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Mª Dolores MD Apolo-Arenas, PhD

CONTACT

924489180; mdapolo@unex.es

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 16, 2025
• Study Start: May 5, 2025
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

ES (1)