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

Официальное название

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

Обзор

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

Вмешательства

• Другое 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.

Первичные конечные точки

• Change in Resting Interleukin-7 (IL-7) Concentration [Срок оценки: Baseline and 12 weeks]

Вторичные конечные точки (12)

• Change in Frequencies of Resting Immune Cell Phenotypes [Срок оценки: Baseline and 12 weeks]
• Acute Circulating IL-7 Response to a Single Bout of Exercise [Срок оценки: Week 12]
• Change in Total Lean Mass [Срок оценки: Baseline and 12 weeks]
• Change in Total Fat Mass [Срок оценки: Baseline and 12 weeks]
• Change in Local Muscle Cross-Sectional Area (CSA) [Срок оценки: Baseline and 12 weeks]
• Change in Handgrip Strength [Срок оценки: Baseline, 12 weeks]
• Change in 30-Second Sit-to-Stand Test Performance [Срок оценки: Baseline and 12 weeks]
• Change in Timed Up and Go (TUG) Test Performance [Срок оценки: Baseline and 12 weeks]
• Change in Leg Press Peak Power Output [Срок оценки: Baseline and 12 weeks]
• Change in Leg Press One-Repetition Maximum (1RM) [Срок оценки: Baseline and 12 weeks]
• Change in Glycated Haemoglobin (HbA1c) [Срок оценки: Baseline and 12 weeks]
• Change in Fasting Insulin [Срок оценки: Baseline and 12 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Великобритания · 1 центр

• University of Bath — Bath

Идентификаторы

NCT: NCT07724080 · 16161 · 371008 · 26/WA/0162

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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