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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.

6 maggio 2026 aggiornato da: Universidad Francisco de Vitoria

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Moderate-Intensity Interval Aerobic Exercise
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.
Altro: Moderate-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.
Nessun intervento: Usual Care During Radiotherapy
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Systemic Immune-Inflammation Index (SII)
Lasso di tempo: 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.
Baseline (pre-intervention) and immediately after intervention
Neutrophil-to-Lymphocyte Ratio (NLR)
Lasso di tempo: 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.
Baseline (pre-intervention) and immediately after intervention
Platelet Count
Lasso di tempo: 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.
Baseline (pre-intervention) and immediately after intervention
Neutrophil Count
Lasso di tempo: 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.
Baseline (pre-intervention) and immediately after intervention
Lymphocyte Count
Lasso di tempo: 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.
Baseline (pre-intervention) and immediately after intervention
NT-proBNP
Lasso di tempo: 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.
Baseline (pre-intervention) and immediately after intervention
High-Sensitivity Troponin I
Lasso di tempo: 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.
Baseline (pre-intervention) and immediately after intervention
Body Weight
Lasso di tempo: 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.
Baseline (pre-intervention) and immediately after intervention
Phase angle
Lasso di tempo: 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.
Baseline (pre-intervention) and immediately after intervention
Fat Mass
Lasso di tempo: 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.
Baseline (pre-intervention) and immediately after intervention
Muscle Mass
Lasso di tempo: 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.
Baseline (pre-intervention) and immediately after intervention
Percentage Body Fat
Lasso di tempo: Baseline (pre-intervention) and immediately after intervention
Percentage body fat will be determined using bioelectrical impedance analysis (BIA).
Baseline (pre-intervention) and immediately after intervention
Visceral fat area
Lasso di tempo: 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.
Baseline (pre-intervention) and immediately after intervention
Relative Lower-Limb Power: Handgrip Strength
Lasso di tempo: 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.
Baseline (pre-intervention) and immediately after intervention
Relative Lower-Limb Power (Chair Stand Test)
Lasso di tempo: 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.
Baseline (pre-intervention) and immediately after intervention
Breast Cancer-Specific Functional Quality of Life
Lasso di tempo: 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.
Baseline (pre-intervention) and immediately after intervention
Breast Cancer-Specific Symptom Burden
Lasso di tempo: 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.
Baseline (pre-intervention) and immediately after intervention
Sleep Quality (PSQI)
Lasso di tempo: 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.
Baseline (pre-intervention) and immediately after intervention

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universidad Francisco de Vitoria

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 settembre 2026

Completamento dello studio (Stimato)

31 dicembre 2026

Date di iscrizione allo studio

Primo inviato

6 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2026

Primo Inserito (Effettivo)

13 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • EIMICM1

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

At this time, it is unclear whether individual participant data (IPD) will be shared. Data sharing will depend on institutional policies, ethical approvals, participant privacy considerations, and the feasibility of preparing de-identified datasets. A final decision will be made once data collection and analysis are completed.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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