Breast Cancer, Immune System, Inflamation, Physical Fitness, Radiotherapy
Conditions
Keywords
Interval Training, Inflammation, Body Composition, Quality of Life, Immune function, Breast Cancer, Sleep, oncology rehabilitation
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.
Interventions
OTHERModerate-Intensity Interval Aerobic Exercise
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.
Sponsors
Universidad Francisco de Vitoria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lymphocyte Count | 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. |
| NT-proBNP | 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. |
| High-Sensitivity Troponin I | 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. |
| Body Weight | 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. |
| Phase angle | 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. |
| Fat Mass | 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. |
| Muscle Mass | 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. |
| Percentage Body Fat | Baseline (pre-intervention) and immediately after intervention | Percentage body fat will be determined using bioelectrical impedance analysis (BIA). |
| Visceral fat area | 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. |
| Relative Lower-Limb Power: Handgrip Strength | 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. |
| Relative Lower-Limb Power (Chair Stand Test) | 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. |
| Breast Cancer-Specific Functional Quality of Life | 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. |
| Breast Cancer-Specific Symptom Burden | 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. |
| Sleep Quality (PSQI) | 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. |
| Neutrophil Count | 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. |
| Systemic Immune-Inflammation Index (SII) | 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. |
| Neutrophil-to-Lymphocyte Ratio (NLR) | 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. |
| Platelet Count | 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. |
Contacts
CONTACTÁfrica Ruiz
Outcome results
None listed