RadiotherapyNCT07583719
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.
A study testing Moderate-Intensity Interval Aerobic Exercise in people with Radiotherapy and Inflamation, run by Universidad Francisco de Vitoria.
Trial summary
Breast cancer and its treatment with radiotherapy may be associated with systemic inflammatory, hematological, cardiac, body composition, functional and quality-of-life alterations. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Radiotherapy, Inflamation, Immune System
- What is being tested?
- Moderate-Intensity Interval Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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, Immune System, Physical Fitness, Breast Cancer
- Being tested
- Moderate-Intensity Interval Aerobic Exercise
- Keywords
- Interval Training, Inflammation, Body Composition, Quality of Life, Immune function, Breast Cancer, Sleep, oncology rehabilitation
- Medical subject headings
- Breast Neoplasms, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-intervention) and immediately after intervention
Percentage Body Fat
Percentage body fat will be determined using bioelectrical impedance analysis (BIA).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-intervention) and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583719
- Sponsor's protocol ID
- EIMICM1
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07583719
- Acronym / sponsor ID
- EIMICM1
- Conditions
- Radiotherapy, Inflamation, Immune System, Physical Fitness, Breast Cancer
- Keywords
- Interval Training, Inflammation, Body Composition, Quality of Life, Immune function, Breast Cancer, Sleep, oncology rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate-Intensity Interval Aerobic Exercise | Experimental | Other: Moderate-Intensity Interval Aerobic ExerciseParticipants 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. |
| 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- Presence of infectious disease.
- Cardiovascular or respiratory disease.
- Metastatic disease.
- Uncontrolled diabetes mellitus.
- Neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate-Intensity Interval Aerobic ExerciseStructured 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. | Other | Moderate-Intensity Interval Aerobic Exercise |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Percentage Body Fat
Time frame: Baseline (pre-intervention) and immediately after intervention
Percentage body fat will be determined using bioelectrical impedance analysis (BIA).
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-Intensity Interval Aerobic Exercise in people with Radiotherapy and Inflamation, run by Universidad Francisco de Vitoria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact África Ruiz (+34 913 24 80 64, africa.ruiz@ufv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic Immune-Inflammation Index (SII) (time frame: Baseline (pre-intervention) and immediately after intervention). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.