NCT07724080尚未招募不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Resting Interleukin-7 (IL-7) Concentration
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
- •Written medical clearance to participate from the treating oncologist.
- •Sufficient proficiency in English to comprehend study instructions.
- •Provision of written informed consent.
排除标准
- •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.
结局指标
主要结局
Change in Resting Interleukin-7 (IL-7) Concentration
时间窗: 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.
次要结局
- Change in Frequencies of Resting Immune Cell Phenotypes(Baseline and 12 weeks)
- Acute Circulating IL-7 Response to a Single Bout of Exercise(Week 12)
- Change in Total Lean Mass(Baseline and 12 weeks)
- Change in Total Fat Mass(Baseline and 12 weeks)
- Change in Local Muscle Cross-Sectional Area (CSA)(Baseline and 12 weeks)
- Change in Handgrip Strength(Baseline, 12 weeks)
- Change in 30-Second Sit-to-Stand Test Performance(Baseline and 12 weeks)
- Change in Timed Up and Go (TUG) Test Performance(Baseline and 12 weeks)
- Change in Leg Press Peak Power Output(Baseline and 12 weeks)
- Change in Leg Press One-Repetition Maximum (1RM)(Baseline and 12 weeks)
- Change in Glycated Haemoglobin (HbA1c)(Baseline and 12 weeks)
- Change in Fasting Insulin(Baseline and 12 weeks)
- Change in Fasting Glucose(Baseline and 12 weeks)
- Change in C-Reactive Protein (CRP)(Baseline and 12 weeks)
- Change in Cancer-Specific Quality of Life (EORTC QLQ-C30)(Baseline and 12 weeks)
- Change in Prostate Cancer-Specific Symptoms (EORTC QLQ-PR25)(Baseline and 12 weeks)
- Change in Fatigue Severity (FACIT-Fatigue)(Baseline and 12 weeks)
- Uptake and Retention Rates(Through study completion)
- Incidence of Adverse Events(Throughout the 12-week intervention period)
- Exercise Session Attendance Rate(Throughout the 12-week intervention period)
- Resistance Exercise Dose Adherence(Throughout the 12-week intervention period)
- Average Session Rate of Perceived Exertion (RPE)(Throughout the 12-week intervention period)
- Frequency of Exercise Dose Reductions(Throughout the 12-week intervention period)
- Frequency of Exercise Interruptions(Throughout the 12-week intervention period)
研究者
John Campbell
Senior Lecturer
University of Bath
研究点 (1)
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