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NCT Number: NCT07583719

Effects of Moderate-intensity Interval Aerobic Exercise (MIIAE) on Inflammatory, Immune, Metabolic, Physical Fitness, and Quality of Life Parameters in Breast Cancer Patients Undergoing Radiotherapy.

Breast cancer and its treatment with radiotherapy may be associated with systemic inflammatory, hematological, cardiac, body composition, functional and quality-of-life alterations. Exercise has emerged as a non-pharmacological strategy with potential benefits during oncological treatment; however, further evidence is needed regarding the effects of supervised moderate-intensity interval aerobic exercise during radiotherapy.

This randomized controlled trial aims to evaluate the effects of a supervised moderate-intensity interval aerobic exercise programme on systemic inflammatory and immune-derived hematological indices, cardiac biomarkers, body composition, muscle strength, lower-limb power, sleep quality and breast cancer-specific quality of life in women with breast cancer undergoing radiotherapy.

Participants will be allocated to either an experimental group performing supervised moderate-intensity interval aerobic exercise during radiotherapy or to a control group receiving usual care without structured exercise during the study period. Outcomes will be assessed at baseline and after completion of the intervention period.

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Key information

Conditions

Radiotherapy Breast Cancer Breast Diseases Breast Neoplasms Immune System Inflamation Inflammation Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Physical Fitness Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women aged between 20 and 65 years.
  • Clinical diagnosis of breast cancer (Stage I-III).
  • Patients who have undergone lumpectomy or mastectomy.
  • Scheduled to start radiotherapy treatment.
  • Sedentary lifestyle according to international physical activity guidelines.
  • Ability to understand and follow instructions.
  • Ability to provide written informed consent.

Exclusion criteria

  • Presence of infectious disease.
  • Cardiovascular or respiratory disease.
  • Metastatic disease.
  • Uncontrolled diabetes mellitus.
  • Neuropathy.
  • Physically active individuals meeting WHO physical activity recommendations.
  • Participation in an exercise intervention program within the last 3 months.
  • Any condition that, in the opinion of the research team, may compromise safety or participation.

Treatment and study plan

Moderate-Intensity Interval Aerobic Exercise

Other

Structured and supervised aerobic exercise intervention based on moderate-intensity interval training. The programme includes repeated aerobic exercise bouts interspersed with recovery periods. Exercise intensity is individually prescribed and adjusted according to baseline physiological assessment, including blood lactate response, perceived exertion and clinical tolerance. The intervention is delivered during the radiotherapy treatment period as an adjunct to standard oncological care.

Primary outcomes

  1. Systemic Immune-Inflammation Index (SII)

    Time frame: Baseline (pre-intervention) and immediately after intervention

    Systemic Immune-Inflammation Index (SII) will be calculated from peripheral blood parameters obtained through standard hematological analysis using an automated analyzer. The index will be computed using the formula: platelet count × neutrophil count / lymphocyte count. Blood samples will be collected under standardized conditions after an overnight fast, with participants instructed to avoid vasoactive medication, caffeine, alcohol and tobacco prior to sampling. Post-intervention samples will be obtained at least 48 hours after the last exercise session to ensure assessment of chronic rather than acute responses. This composite index will be used to quantify changes in systemic inflammatory and immune status associated with the intervention.

  2. Neutrophil-to-Lymphocyte Ratio (NLR)

    Time frame: Baseline (pre-intervention) and immediately after intervention

    Neutrophil-to-Lymphocyte Ratio (NLR) will be calculated from absolute neutrophil and lymphocyte counts obtained through peripheral blood analysis using an automated hematology analyzer. This index will be used as a marker of systemic inflammatory balance.

  3. Platelet Count

    Time frame: Baseline (pre-intervention) and immediately after intervention

    Platelet count will be obtained from peripheral blood samples using standard hematological procedures and automated analysis, and will be used as a parameter of systemic inflammatory and hematological status.

  4. Neutrophil Count

    Time frame: Baseline (pre-intervention) and immediately after intervention

    Absolute neutrophil count will be obtained from peripheral blood analysis using an automated hematology analyzer and will be used to assess innate immune response.

  5. Lymphocyte Count

    Time frame: Baseline (pre-intervention) and immediately after intervention

    Absolute lymphocyte count will be obtained from peripheral blood analysis using an automated hematology analyzer and will be used to assess adaptive immune status.

  6. NT-proBNP

    Time frame: Baseline (pre-intervention) and immediately after intervention

    N-terminal pro-B-type natriuretic peptide (NT-proBNP) will be quantified in venous blood samples (pg/ml) using standardized laboratory assays according to manufacturer instructions, as a biomarker of cardiac stress and subclinical cardiac involvement.

  7. High-Sensitivity Troponin I

    Time frame: Baseline (pre-intervention) and immediately after intervention

    High-sensitivity troponin I (hs-TnI) will be measured in venous blood samples (ng/L) using validated high-sensitivity assays according to manufacturer protocols, as a biomarker of myocardial injury.

  8. Body Weight

    Time frame: Baseline (pre-intervention) and immediately after intervention

    Body weight will be measured in kilograms using calibrated scales under standardized conditions, with participants in light clothing and barefoot.

  9. Phase angle

    Time frame: Baseline (pre-intervention) and immediately after intervention

    Phase angle will be assessed using multifrequency octopolar bioelectrical impedance analysis (BIA) under standardized conditions, including fasting state and controlled hydration status, as an indicator of cellular integrity and body cell mass.

  10. Fat Mass

    Time frame: Baseline (pre-intervention) and immediately after intervention

    Fat mass will be assessed using bioelectrical impedance analysis (BIA) following standardized pre-measurement conditions, including fasting and abstinence from exercise, caffeine and alcohol.

  11. Muscle Mass

    Time frame: Baseline (pre-intervention) and immediately after intervention

    Muscle mass will be assessed using bioelectrical impedance analysis (BIA) under standardized conditions to evaluate skeletal muscle status.

  12. Percentage Body Fat

    Time frame: Baseline (pre-intervention) and immediately after intervention

    Percentage body fat will be determined using bioelectrical impedance analysis (BIA).

  13. Visceral fat area

    Time frame: Baseline (pre-intervention) and immediately after intervention

    Visceral fat area (VFA) will be estimated using bioelectrical impedance analysis as an indicator of central adiposity and cardiometabolic risk.

  14. Relative Lower-Limb Power: Handgrip Strength

    Time frame: Baseline (pre-intervention) and immediately after intervention

    Right and left handgrip strength will be measured (kg) using a calibrated handheld dynamometer. Participants will perform three maximal voluntary contractions per hand following standardized procedures, with adequate rest between attempts. The highest reproducible value for each hand will be recorded.

  15. Relative Lower-Limb Power (Chair Stand Test)

    Time frame: Baseline (pre-intervention) and immediately after intervention

    Relative lower-limb power will be assessed using the 30-second Chair Stand Test. Participants will perform as many full stands as possible from a standardized chair (≈43-45 cm height) within 30 seconds, with arms crossed over the chest. The number of repetitions will be recorded. A relative lower-limb power index will be derived from repetitions and body mass, expressed in W/kg equivalent units, providing an estimate of lower-limb functional performance normalized by body mass.

  16. Breast Cancer-Specific Functional Quality of Life

    Time frame: Baseline (pre-intervention) and immediately after intervention

    Functional quality of life will be assessed using the functional scales of the EORTC QLQ-C30 and QLQ-BR45 questionnaires. Scores will be linearly transformed to a 0-100 scale, where higher scores indicate better functional status.

  17. Breast Cancer-Specific Symptom Burden

    Time frame: Baseline (pre-intervention) and immediately after intervention

    Symptom burden will be assessed using the symptom scales of the EORTC QLQ-C30 and QLQ-BR45 questionnaires. Scores will be transformed to a 0-100 scale, where higher scores indicate greater symptom severity.

  18. Sleep Quality (PSQI)

    Time frame: Baseline (pre-intervention) and immediately after intervention

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The global score will be used for analysis, where higher scores indicate poorer sleep quality.

Study contacts

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

África Ruiz

CONTACT

[email protected]

+34 913 24 80 64

Sponsors and collaborators

Lead sponsor

Universidad Francisco de Vitoria

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 13, 2026
Registry last updated
May 13, 2026

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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