Resistance Exercise, IL-7 and Immune Phenotypes in Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Supervised Resistance Exercise Programme.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Muscle Loss. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
Interventions
- Other 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.
Primary outcome measures
- Change in Resting Interleukin-7 (IL-7) Concentration [Time frame: Baseline and 12 weeks]
Secondary outcome measures (12)
- Change in Frequencies of Resting Immune Cell Phenotypes [Time frame: Baseline and 12 weeks]
- Acute Circulating IL-7 Response to a Single Bout of Exercise [Time frame: Week 12]
- Change in Total Lean Mass [Time frame: Baseline and 12 weeks]
- Change in Total Fat Mass [Time frame: Baseline and 12 weeks]
- Change in Local Muscle Cross-Sectional Area (CSA) [Time frame: Baseline and 12 weeks]
- Change in Handgrip Strength [Time frame: Baseline, 12 weeks]
- Change in 30-Second Sit-to-Stand Test Performance [Time frame: Baseline and 12 weeks]
- Change in Timed Up and Go (TUG) Test Performance [Time frame: Baseline and 12 weeks]
- Change in Leg Press Peak Power Output [Time frame: Baseline and 12 weeks]
- Change in Leg Press One-Repetition Maximum (1RM) [Time frame: Baseline and 12 weeks]
- Change in Glycated Haemoglobin (HbA1c) [Time frame: Baseline and 12 weeks]
- Change in Fasting Insulin [Time frame: Baseline and 12 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United Kingdom · 1 center
- University of Bath — Bath
Identifiers
NCT: NCT07724080 · 16161 · 371008 · 26/WA/0162