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Resistance Exercise, IL-7 and Immune Phenotypes in Prostate Cancer

20 luglio 2026 aggiornato da: John Campbell, University of Bath

Effects of Resistance Exercise on IL-7 and Immune Cell Phenotypes in Men With Prostate Cancer Receiving Androgen Deprivation Therapy Prior to Radiotherapy: A Pilot Study

Hormone therapy for prostate cancer typically causes significant muscle loss. Skeletal muscle releases Interleukin-7 (IL-7), a signalling protein that supports the production of new immune cells. Therefore, losing muscle during cancer treatment may actively weaken the immune system. The goal of this clinical trial is to investigate if a 12-week supervised resistance exercise (strength training) programme can prevent this muscle loss and increase levels of IL-7.

The main questions it aims to answer are:

  • Does a 12-week strength training programme raise resting IL-7 levels and increase newly formed immune cell counts?
  • Does a single session of strength training trigger an immediate release of IL-7?
  • To what extent do exercise-induced improvements in muscle mass and strength translate into reduced fatigue, better physical function, higher quality of life, and improved cardiometabolic health?
  • Is the exercise programme safe and well-tolerated during hormone therapy?

Researchers will compare a Resistance Exercise Group to a Usual Care Group to see the effects of strength training against standard medical care.

Participants will:

  • Attend a screening visit to check eligibility.
  • Complete baseline assessments, including body composition scans, blood tests, fitness tests, and questionnaires.
  • Be randomly assigned to either the exercise group or the usual care group.
  • Complete three supervised strength training sessions per week for 12 weeks, if assigned to the exercise group.
  • Continue with standard medical care, if assigned to the usual care group.
  • Repeat all assessments at the end of the 12 weeks.
  • Perform one short exercise session during the final visit, with extra blood samples taken before and after to track immediate changes

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

  • Nome: Fernando Alonso
  • Numero di telefono: +447760199388
  • Email: fag34@bath.ac.uk

Luoghi di studio

  • Regno Unito
    • Somerset
      • Bath, Somerset, Regno Unito, BA2 7AY
        • University of Bath
        • Contatto:

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:

  • Histologically confirmed diagnosis of localised prostate cancer (clinical stage T1-3b, N0-1, M0 and a Gleason score of 6-10).
  • Scheduled to undergo curative-intent treatment involving neoadjuvant androgen deprivation therapy (ADT) for a duration of at least 3 months, alongside radiotherapy.
  • Recruited prior to, or within the first 2 weeks of, initiating ADT.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Written medical clearance to participate from the treating oncologist.
  • Sufficient proficiency in English to comprehend study instructions.
  • Provision of written informed consent.

Exclusion Criteria:

  • Evidence of distant metastases (M1).
  • Uncontrolled cardiovascular conditions (e.g., uncontrolled hypertension, unstable angina, or a myocardial infarction within the past 6 months).
  • Musculoskeletal pathologies or conditions that would preclude the safe execution of resistance exercise.
  • A known history of autoimmune disease.
  • Current use of chronic systemic corticosteroids or other immunosuppressive agents.
  • Engagement in structured resistance exercise within the preceding 3 months.

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: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Usual Care Group
Participants receive standard medical care for 12 weeks. They do not participate in the supervised exercise sessions and are instructed not to initiate any new structured resistance exercise programme during the study period.
Sperimentale: Resistance Exercise Group
In addition to standard medical care, participants undergo a 12-week, supervised resistance exercise programme.
Altro: Supervised Resistance Exercise Programme
A 12-week, supervised resistance training programme delivered in small groups in a gym setting. Participants will train 3 times per week on non-consecutive days, with sessions lasting 45-60 minutes. The programme targets all major muscle groups, with volume and intensity gradually increasing throughout the intervention period.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Resting Interleukin-7 (IL-7) Concentration
Lasso di tempo: Baseline and 12 weeks
Assessed via enzyme-linked immunosorbent assay (ELISA) from resting, fasting blood samples to evaluate changes in baseline immune-supporting signaling proteins.
Baseline and 12 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Frequencies of Resting Immune Cell Phenotypes
Lasso di tempo: Baseline and 12 weeks
Assessed via flow cytometry from resting, fasting blood samples to evaluate key immune cell populations, specifically naïve CD4+ T-cells, naïve CD8+ T-cells, and naïve B-cells.
Baseline and 12 weeks
Acute Circulating IL-7 Response to a Single Bout of Exercise
Lasso di tempo: Week 12
Quantified as the incremental Area Under the Curve (iAUC) of circulating IL-7 via ELISA. Blood samples are taken at rest, immediately post-exercise, and 30 minutes post-exercise.
Week 12
Change in Total Lean Mass
Lasso di tempo: Baseline and 12 weeks
Measured via Dual-Energy X-ray Absorptiometry (DEXA) to evaluate changes in lean tissue.
Baseline and 12 weeks
Change in Total Fat Mass
Lasso di tempo: Baseline and 12 weeks
Measured via Dual-Energy X-ray Absorptiometry (DEXA) to evaluate changes in body fat.
Baseline and 12 weeks
Change in Local Muscle Cross-Sectional Area (CSA)
Lasso di tempo: Baseline and 12 weeks
Local muscle cross-sectional area (CSA) assessed via peripheral Quantitative Computed Tomography (pQCT) to assess changes in specific muscle size.
Baseline and 12 weeks
Change in Handgrip Strength
Lasso di tempo: Baseline, 12 weeks
Measured using a hand dynamometer to assess upper-body isometric strength
Baseline, 12 weeks
Change in 30-Second Sit-to-Stand Test Performance
Lasso di tempo: Baseline and 12 weeks
Evaluated by the number of sit-to-stand repetitions completed in 30 seconds to assess lower-body functional strength.
Baseline and 12 weeks
Change in Timed Up and Go (TUG) Test Performance
Lasso di tempo: Baseline and 12 weeks
Assessed using the Timed Up and Go Test (TUG) to evaluate changes in functional mobility and balance.
Baseline and 12 weeks
Change in Leg Press Peak Power Output
Lasso di tempo: Baseline and 12 weeks
Assessed using a Keiser leg press to determine peak power output
Baseline and 12 weeks
Change in Leg Press One-Repetition Maximum (1RM)
Lasso di tempo: Baseline and 12 weeks
Assessed using a Keiser leg press to determine 1-repetition maximum (1RM).
Baseline and 12 weeks
Change in Glycated Haemoglobin (HbA1c)
Lasso di tempo: Baseline and 12 weeks
Analyzed from resting, fasting blood samples to monitor long-term glycemic control.
Baseline and 12 weeks
Change in Fasting Insulin
Lasso di tempo: Baseline and 12 weeks
Analyzed from resting, fasting blood samples to evaluate insulin levels and metabolic health
Baseline and 12 weeks
Change in Fasting Glucose
Lasso di tempo: Baseline and 12 weeks
Analyzed from resting, fasting blood samples to evaluate baseline glycemic control
Baseline and 12 weeks
Change in C-Reactive Protein (CRP)
Lasso di tempo: Baseline and 12 weeks
Analyzed from resting, fasting blood samples to assess baseline systemic inflammation.
Baseline and 12 weeks
Change in Cancer-Specific Quality of Life (EORTC QLQ-C30)
Lasso di tempo: Baseline and 12 weeks
Evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores range from 0 to 100, where higher scores represent a better quality of life.
Baseline and 12 weeks
Change in Prostate Cancer-Specific Symptoms (EORTC QLQ-PR25)
Lasso di tempo: Baseline and 12 weeks
Evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Prostate Cancer Module (EORTC QLQ-PR25). Scores range from 0 to 100, where higher scores represent higher symptom burden (worse outcome).
Baseline and 12 weeks
Change in Fatigue Severity (FACIT-Fatigue)
Lasso di tempo: Baseline and 12 weeks
Evaluated using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale. Scores range from 0 to 52, where higher scores represent lower levels of fatigue (better outcome).
Baseline and 12 weeks
Uptake and Retention Rates
Lasso di tempo: Through study completion
Uptake is calculated as the percentage of invited eligible patients who consent to participate. Retention is the percentage of randomised participants who successfully complete the final post-intervention assessments.
Through study completion
Incidence of Adverse Events
Lasso di tempo: Throughout the 12-week intervention period
Total number and percentage of participants experiencing adverse events, systematically tracked and evaluated for seriousness and causality.
Throughout the 12-week intervention period
Exercise Session Attendance Rate
Lasso di tempo: Throughout the 12-week intervention period
Calculated as the percentage of the total prescribed supervised exercise sessions successfully attended by the participants in the intervention group.
Throughout the 12-week intervention period
Resistance Exercise Dose Adherence
Lasso di tempo: Throughout the 12-week intervention period
Calculated as the percentage of total prescribed exercise sets completed by the participants in the intervention group
Throughout the 12-week intervention period
Average Session Rate of Perceived Exertion (RPE)
Lasso di tempo: Throughout the 12-week intervention period
Evaluated using the Borg Rating of Perceived Exertion (RPE) Category-Ratio scale (CR10). Scores range from 0 (no exertion at all) to 10 (maximal exertion), recorded at the end of each session and averaged for participants in the intervention group. Higher scores represent a higher perceived physical effort.
Throughout the 12-week intervention period
Frequency of Exercise Dose Reductions
Lasso di tempo: Throughout the 12-week intervention period
Calculated as the percentage of attended exercise sessions where the prescribed volume or intensity had to be modified or reduced due to fatigue or intolerance in the intervention group.
Throughout the 12-week intervention period
Frequency of Exercise Interruptions
Lasso di tempo: Throughout the 12-week intervention period
The total count of instances where a participant in the intervention group missed 3 or more consecutive scheduled exercise sessions.
Throughout the 12-week intervention period

Collaboratori e investigatori

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

Sponsor

University of Bath

Collaboratori

Royal United Hospitals Bath NHS Foundation Trust

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 agosto 2026

Completamento primario (Stimato)

1 settembre 2028

Completamento dello studio (Stimato)

1 settembre 2028

Date di iscrizione allo studio

Primo inviato

2 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 luglio 2026

Primo Inserito (Effettivo)

23 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 16161
  • 371008 (Altro identificatore: Integrated Research Application System (IRAS))
  • 26/WA/0162 (Altro identificatore: Wales Research Ethics Committee 1)

Piano per i dati dei singoli partecipanti (IPD)

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

INDECISO

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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