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.

NCT07583719 | Not Yet Recruiting

• 1 other identifier: EIMICM1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Radiotherapy; Inflamation; Physical Fitness; Breast Cancer; Immune System

Keywords

Interval Training; Inflammation; Body Composition; Quality of Life; Immune function; Breast Cancer; Sleep; oncology rehabilitation

Outcome Measures

Primary Outcomes (18)

• Systemic Immune-Inflammation Index (SII)

  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.

  Baseline (pre-intervention) and immediately after intervention

• Neutrophil-to-Lymphocyte Ratio (NLR)

  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.

  Baseline (pre-intervention) and immediately after intervention

• Platelet Count

  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.

  Baseline (pre-intervention) and immediately after intervention

• Neutrophil Count

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

  Baseline (pre-intervention) and immediately after intervention

• Lymphocyte Count

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

  Baseline (pre-intervention) and immediately after intervention

• NT-proBNP

  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.

  Baseline (pre-intervention) and immediately after intervention

• High-Sensitivity Troponin I

  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.

  Baseline (pre-intervention) and immediately after intervention

• Body Weight

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

  Baseline (pre-intervention) and immediately after intervention

• Phase angle

  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.

  Baseline (pre-intervention) and immediately after intervention

• Fat Mass

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

  Baseline (pre-intervention) and immediately after intervention

• Muscle Mass

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

  Baseline (pre-intervention) and immediately after intervention

• Percentage Body Fat

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

  Baseline (pre-intervention) and immediately after intervention

• Visceral fat area

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

  Baseline (pre-intervention) and immediately after intervention

• Relative Lower-Limb Power: Handgrip Strength

  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.

  Baseline (pre-intervention) and immediately after intervention

• Relative Lower-Limb Power (Chair Stand Test)

  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.

  Baseline (pre-intervention) and immediately after intervention

• Breast Cancer-Specific Functional Quality of Life

  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.

  Baseline (pre-intervention) and immediately after intervention

• Breast Cancer-Specific Symptom Burden

  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.

  Baseline (pre-intervention) and immediately after intervention

• Sleep Quality (PSQI)

  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.

  Baseline (pre-intervention) and immediately after intervention

Study Arms (2)

Moderate-Intensity Interval Aerobic Exercise

EXPERIMENTAL

Participants perform a supervised moderate-intensity interval aerobic exercise programme during the radiotherapy treatment period. Training is conducted 3 days per week, on alternate days, under the supervision of a physiotherapist experienced in therapeutic exercise in oncology. Exercise intensity is prescribed individually according to baseline physiological testing, including lactate response, perceived exertion and clinical tolerance. Participants continue receiving standard oncological care during radiotherapy.

Other: Moderate-Intensity Interval Aerobic Exercise

Usual Care During Radiotherapy

NO INTERVENTION

Participants allocated to the control group receive standard oncological care during the radiotherapy treatment period and do not participate in a structured exercise programme during the study period. Participants are instructed to maintain their usual lifestyle throughout radiotherapy. After completion of the study, participants in the control group are offered the same supervised moderate-intensity interval aerobic exercise programme delivered to the experimental group.

Interventions

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.

Moderate-Intensity Interval Aerobic Exercise

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Francisco de Vitoria: lead

MeSH Terms

Conditions

Breast Neoplasms; Inflammation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

África Ruiz

CONTACT

+34 913 24 80 64; africa.ruiz@ufv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05