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

20 de julho de 2026 atualizado por: 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

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

40

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Fernando Alonso
  • Número de telefone: +447760199388
  • E-mail: fag34@bath.ac.uk

Locais de estudo

  • Reino Unido
    • Somerset
      • Bath, Somerset, Reino Unido, BA2 7AY
        • University of Bath
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: 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.
Experimental: Resistance Exercise Group
In addition to standard medical care, participants undergo a 12-week, supervised resistance exercise programme.
Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Resting Interleukin-7 (IL-7) Concentration
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Frequencies of Resting Immune Cell Phenotypes
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: Baseline and 12 weeks
Analyzed from resting, fasting blood samples to monitor long-term glycemic control.
Baseline and 12 weeks
Change in Fasting Insulin
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Bath

Colaboradores

Royal United Hospitals Bath NHS Foundation Trust

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de agosto de 2026

Conclusão Primária (Estimado)

1 de setembro de 2028

Conclusão do estudo (Estimado)

1 de setembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

2 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de julho de 2026

Primeira postagem (Real)

23 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

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Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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