Resistance Exercise, IL-7 and Immune Phenotypes in Prostate Cancer
20. července 2026 aktualizováno: 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
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Odhadovaný)
40
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Fernando Alonso
- Telefonní číslo: +447760199388
- E-mail: fag34@bath.ac.uk
Studijní místa
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Somerset
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Bath, Somerset, Spojené království, BA2 7AY
- University of Bath
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Kontakt:
- Fernando Alonso
- Telefonní číslo: 07760199388
- E-mail: fag34@bath.ac.uk
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Žádný zásah: 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.
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|
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Experimentální: Resistance Exercise Group
In addition to standard medical care, participants undergo a 12-week, supervised resistance exercise programme.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Resting Interleukin-7 (IL-7) Concentration
Časové okno: Baseline and 12 weeks
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Assessed via enzyme-linked immunosorbent assay (ELISA) from resting, fasting blood samples to evaluate changes in baseline immune-supporting signaling proteins.
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Baseline and 12 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Frequencies of Resting Immune Cell Phenotypes
Časové okno: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
|
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Acute Circulating IL-7 Response to a Single Bout of Exercise
Časové okno: Week 12
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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.
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Week 12
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Change in Total Lean Mass
Časové okno: Baseline and 12 weeks
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Measured via Dual-Energy X-ray Absorptiometry (DEXA) to evaluate changes in lean tissue.
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Baseline and 12 weeks
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Change in Total Fat Mass
Časové okno: Baseline and 12 weeks
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Measured via Dual-Energy X-ray Absorptiometry (DEXA) to evaluate changes in body fat.
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Baseline and 12 weeks
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Change in Local Muscle Cross-Sectional Area (CSA)
Časové okno: Baseline and 12 weeks
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Local muscle cross-sectional area (CSA) assessed via peripheral Quantitative Computed Tomography (pQCT) to assess changes in specific muscle size.
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Baseline and 12 weeks
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Change in Handgrip Strength
Časové okno: Baseline, 12 weeks
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Measured using a hand dynamometer to assess upper-body isometric strength
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Baseline, 12 weeks
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Change in 30-Second Sit-to-Stand Test Performance
Časové okno: Baseline and 12 weeks
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Evaluated by the number of sit-to-stand repetitions completed in 30 seconds to assess lower-body functional strength.
|
Baseline and 12 weeks
|
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Change in Timed Up and Go (TUG) Test Performance
Časové okno: Baseline and 12 weeks
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Assessed using the Timed Up and Go Test (TUG) to evaluate changes in functional mobility and balance.
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Baseline and 12 weeks
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Change in Leg Press Peak Power Output
Časové okno: Baseline and 12 weeks
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Assessed using a Keiser leg press to determine peak power output
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Baseline and 12 weeks
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Change in Leg Press One-Repetition Maximum (1RM)
Časové okno: Baseline and 12 weeks
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Assessed using a Keiser leg press to determine 1-repetition maximum (1RM).
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Baseline and 12 weeks
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Change in Glycated Haemoglobin (HbA1c)
Časové okno: Baseline and 12 weeks
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Analyzed from resting, fasting blood samples to monitor long-term glycemic control.
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Baseline and 12 weeks
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Change in Fasting Insulin
Časové okno: Baseline and 12 weeks
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Analyzed from resting, fasting blood samples to evaluate insulin levels and metabolic health
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Baseline and 12 weeks
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Change in Fasting Glucose
Časové okno: Baseline and 12 weeks
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Analyzed from resting, fasting blood samples to evaluate baseline glycemic control
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Baseline and 12 weeks
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Change in C-Reactive Protein (CRP)
Časové okno: Baseline and 12 weeks
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Analyzed from resting, fasting blood samples to assess baseline systemic inflammation.
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Baseline and 12 weeks
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Change in Cancer-Specific Quality of Life (EORTC QLQ-C30)
Časové okno: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Change in Prostate Cancer-Specific Symptoms (EORTC QLQ-PR25)
Časové okno: Baseline and 12 weeks
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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).
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Baseline and 12 weeks
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Change in Fatigue Severity (FACIT-Fatigue)
Časové okno: Baseline and 12 weeks
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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).
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Baseline and 12 weeks
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Uptake and Retention Rates
Časové okno: Through study completion
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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.
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Through study completion
|
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Incidence of Adverse Events
Časové okno: Throughout the 12-week intervention period
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Total number and percentage of participants experiencing adverse events, systematically tracked and evaluated for seriousness and causality.
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Throughout the 12-week intervention period
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Exercise Session Attendance Rate
Časové okno: Throughout the 12-week intervention period
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Calculated as the percentage of the total prescribed supervised exercise sessions successfully attended by the participants in the intervention group.
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Throughout the 12-week intervention period
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Resistance Exercise Dose Adherence
Časové okno: Throughout the 12-week intervention period
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Calculated as the percentage of total prescribed exercise sets completed by the participants in the intervention group
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Throughout the 12-week intervention period
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Average Session Rate of Perceived Exertion (RPE)
Časové okno: Throughout the 12-week intervention period
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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.
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Throughout the 12-week intervention period
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Frequency of Exercise Dose Reductions
Časové okno: Throughout the 12-week intervention period
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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.
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Throughout the 12-week intervention period
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Frequency of Exercise Interruptions
Časové okno: Throughout the 12-week intervention period
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The total count of instances where a participant in the intervention group missed 3 or more consecutive scheduled exercise sessions.
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Throughout the 12-week intervention period
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. srpna 2026
Primární dokončení (Odhadovaný)
1. září 2028
Dokončení studie (Odhadovaný)
1. září 2028
Termíny zápisu do studia
První předloženo
2. července 2026
První předloženo, které splnilo kritéria kontroly kvality
20. července 2026
První zveřejněno (Aktuální)
23. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
23. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
20. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Onemocnění genitálií
- Neurologické projevy
- Nemoci nervového systému
- Neuromuskulární projevy
- Genitální novotvary, muži
- Urogenitální novotvary
- Novotvary podle místa
- Novotvary
- Onemocnění pohlavních orgánů, muž
- Onemocnění prostaty
- Mužská urogenitální onemocnění
- Patologické stavy, anatomické
- Atrofie
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Novotvary prostaty
- Svalová atrofie
Další identifikační čísla studie
- 16161
- 371008 (Jiný identifikátor: Integrated Research Application System (IRAS))
- 26/WA/0162 (Jiný identifikátor: Wales Research Ethics Committee 1)
Plán pro data jednotlivých účastníků (IPD)
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