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

20 juli 2026 uppdaterad av: 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

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

40

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Storbritannien
    • Somerset
      • Bath, Somerset, Storbritannien, BA2 7AY
        • University of Bath
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: 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.
Experimentell: Resistance Exercise Group
In addition to standard medical care, participants undergo a 12-week, supervised resistance exercise programme.
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Resting Interleukin-7 (IL-7) Concentration
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Frequencies of Resting Immune Cell Phenotypes
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: Baseline and 12 weeks
Analyzed from resting, fasting blood samples to monitor long-term glycemic control.
Baseline and 12 weeks
Change in Fasting Insulin
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Bath

Samarbetspartners

Royal United Hospitals Bath NHS Foundation Trust

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 augusti 2026

Primärt slutförande (Beräknad)

1 september 2028

Avslutad studie (Beräknad)

1 september 2028

Studieregistreringsdatum

Först inskickad

2 juli 2026

Först inskickad som uppfyllde QC-kriterierna

20 juli 2026

Första postat (Faktisk)

23 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

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