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.

N/ANot Yet RecruitingNCT07583719

Universidad Francisco de Vitoria40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Radiotherapy Inflamation

Interventions

Moderate-Intensity Interval Aerobic ExerciseOTHER

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.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.