Muscle Loss, Prostate Cancer
Conditions
Keywords
Prostate cancer, resistance exercise, androgen deprivation therapy, interleukin-7, immune function, prehabilitation
Brief summary
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
OTHERSupervised 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.
Sponsors
University of Bath
Royal United Hospitals Bath NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Resting Interleukin-7 (IL-7) Concentration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Frequencies of Resting Immune Cell Phenotypes | 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. |
| Acute Circulating IL-7 Response to a Single Bout of Exercise | 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. |
| Change in Total Lean Mass | Baseline and 12 weeks | Measured via Dual-Energy X-ray Absorptiometry (DEXA) to evaluate changes in lean tissue. |
| Change in Total Fat Mass | Baseline and 12 weeks | Measured via Dual-Energy X-ray Absorptiometry (DEXA) to evaluate changes in body fat. |
| Change in Local Muscle Cross-Sectional Area (CSA) | Baseline and 12 weeks | Local muscle cross-sectional area (CSA) assessed via peripheral Quantitative Computed Tomography (pQCT) to assess changes in specific muscle size. |
| Change in Handgrip Strength | Baseline, 12 weeks | Measured using a hand dynamometer to assess upper-body isometric strength |
| Change in 30-Second Sit-to-Stand Test Performance | Baseline and 12 weeks | Evaluated by the number of sit-to-stand repetitions completed in 30 seconds to assess lower-body functional strength. |
| Change in Timed Up and Go (TUG) Test Performance | Baseline and 12 weeks | Assessed using the Timed Up and Go Test (TUG) to evaluate changes in functional mobility and balance. |
| Change in Leg Press Peak Power Output | Baseline and 12 weeks | Assessed using a Keiser leg press to determine peak power output |
| Change in Leg Press One-Repetition Maximum (1RM) | Baseline and 12 weeks | Assessed using a Keiser leg press to determine 1-repetition maximum (1RM). |
| Change in Glycated Haemoglobin (HbA1c) | Baseline and 12 weeks | Analyzed from resting, fasting blood samples to monitor long-term glycemic control. |
| Change in Fasting Insulin | Baseline and 12 weeks | Analyzed from resting, fasting blood samples to evaluate insulin levels and metabolic health |
| Change in Fasting Glucose | Baseline and 12 weeks | Analyzed from resting, fasting blood samples to evaluate baseline glycemic control |
| Change in C-Reactive Protein (CRP) | Baseline and 12 weeks | Analyzed from resting, fasting blood samples to assess baseline systemic inflammation. |
| Change in Cancer-Specific Quality of Life (EORTC QLQ-C30) | 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. |
| Change in Prostate Cancer-Specific Symptoms (EORTC QLQ-PR25) | 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). |
| Change in Fatigue Severity (FACIT-Fatigue) | 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). |
| Uptake and Retention Rates | 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. |
| Incidence of Adverse Events | Throughout the 12-week intervention period | Total number and percentage of participants experiencing adverse events, systematically tracked and evaluated for seriousness and causality. |
| Exercise Session Attendance Rate | 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. |
| Resistance Exercise Dose Adherence | Throughout the 12-week intervention period | Calculated as the percentage of total prescribed exercise sets completed by the participants in the intervention group |
| Average Session Rate of Perceived Exertion (RPE) | 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. |
| Frequency of Exercise Dose Reductions | 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. |
| Frequency of Exercise Interruptions | 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. |
Countries
United Kingdom
Contacts
CONTACTFernando Alonso
Outcome results
None listed