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

20 juillet 2026 mis à jour par: 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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

40

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Fernando Alonso
  • Numéro de téléphone: +447760199388
  • E-mail: fag34@bath.ac.uk

Lieux d'étude

  • Royaume-Uni
    • Somerset
      • Bath, Somerset, Royaume-Uni, BA2 7AY
        • University of Bath
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: 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.
Expérimental: Resistance Exercise Group
In addition to standard medical care, participants undergo a 12-week, supervised resistance exercise programme.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Resting Interleukin-7 (IL-7) Concentration
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Frequencies of Resting Immune Cell Phenotypes
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: Baseline and 12 weeks
Analyzed from resting, fasting blood samples to monitor long-term glycemic control.
Baseline and 12 weeks
Change in Fasting Insulin
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Bath

Collaborateurs

Royal United Hospitals Bath NHS Foundation Trust

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

1 septembre 2028

Achèvement de l'étude (Estimé)

1 septembre 2028

Dates d'inscription aux études

Première soumission

2 juillet 2026

Première soumission répondant aux critères de contrôle qualité

20 juillet 2026

Première publication (Réel)

23 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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