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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer; Muscle Loss
• Intervention / Treatment: Other: Supervised Resistance Exercise Programme

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fernando Alonso; Phone Number: +447760199388; Email: fag34@bath.ac.uk

Study Locations

• United Kingdom
  • Somerset
    • Bath, Somerset, United Kingdom, BA2 7AY
      • University of Bath
      • Contact: Fernando Alonso; Phone Number: 07760199388; Email: fag34@bath.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: Resistance Exercise Group; In addition to standard medical care, participants undergo a 12-week, supervised resistance exercise programme.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Resting Interleukin-7 (IL-7) Concentration	Assessed via enzyme-linked immunosorbent assay (ELISA) from resting, fasting blood samples to evaluate changes in baseline immune-supporting signaling proteins.	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Frequencies of Resting Immune Cell Phenotypes	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.	Baseline and 12 weeks
Acute Circulating IL-7 Response to a Single Bout of Exercise	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.	Week 12
Change in Total Lean Mass	Measured via Dual-Energy X-ray Absorptiometry (DEXA) to evaluate changes in lean tissue.	Baseline and 12 weeks
Change in Total Fat Mass	Measured via Dual-Energy X-ray Absorptiometry (DEXA) to evaluate changes in body fat.	Baseline and 12 weeks
Change in Local Muscle Cross-Sectional Area (CSA)	Local muscle cross-sectional area (CSA) assessed via peripheral Quantitative Computed Tomography (pQCT) to assess changes in specific muscle size.	Baseline and 12 weeks
Change in Handgrip Strength	Measured using a hand dynamometer to assess upper-body isometric strength	Baseline, 12 weeks
Change in 30-Second Sit-to-Stand Test Performance	Evaluated by the number of sit-to-stand repetitions completed in 30 seconds to assess lower-body functional strength.	Baseline and 12 weeks
Change in Timed Up and Go (TUG) Test Performance	Assessed using the Timed Up and Go Test (TUG) to evaluate changes in functional mobility and balance.	Baseline and 12 weeks
Change in Leg Press Peak Power Output	Assessed using a Keiser leg press to determine peak power output	Baseline and 12 weeks
Change in Leg Press One-Repetition Maximum (1RM)	Assessed using a Keiser leg press to determine 1-repetition maximum (1RM).	Baseline and 12 weeks
Change in Glycated Haemoglobin (HbA1c)	Analyzed from resting, fasting blood samples to monitor long-term glycemic control.	Baseline and 12 weeks
Change in Fasting Insulin	Analyzed from resting, fasting blood samples to evaluate insulin levels and metabolic health	Baseline and 12 weeks
Change in Fasting Glucose	Analyzed from resting, fasting blood samples to evaluate baseline glycemic control	Baseline and 12 weeks
Change in C-Reactive Protein (CRP)	Analyzed from resting, fasting blood samples to assess baseline systemic inflammation.	Baseline and 12 weeks
Change in Cancer-Specific Quality of Life (EORTC QLQ-C30)	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.	Baseline and 12 weeks
Change in Prostate Cancer-Specific Symptoms (EORTC QLQ-PR25)	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).	Baseline and 12 weeks
Change in Fatigue Severity (FACIT-Fatigue)	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).	Baseline and 12 weeks
Uptake and Retention Rates	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.	Through study completion
Incidence of Adverse Events	Total number and percentage of participants experiencing adverse events, systematically tracked and evaluated for seriousness and causality.	Throughout the 12-week intervention period
Exercise Session Attendance Rate	Calculated as the percentage of the total prescribed supervised exercise sessions successfully attended by the participants in the intervention group.	Throughout the 12-week intervention period
Resistance Exercise Dose Adherence	Calculated as the percentage of total prescribed exercise sets completed by the participants in the intervention group	Throughout the 12-week intervention period
Average Session Rate of Perceived Exertion (RPE)	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.	Throughout the 12-week intervention period
Frequency of Exercise Dose Reductions	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.	Throughout the 12-week intervention period
Frequency of Exercise Interruptions	The total count of instances where a participant in the intervention group missed 3 or more consecutive scheduled exercise sessions.	Throughout the 12-week intervention period

Collaborators and Investigators

• Sponsor: University of Bath
• Collaborators: Royal United Hospitals Bath NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Prostate cancer; resistance exercise; prehabilitation; immune function; androgen deprivation therapy; interleukin-7
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Atrophy; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Prostatic Neoplasms; Muscular Atrophy
• Other Study ID Numbers: 16161; 371008 (Other Identifier: Integrated Research Application System (IRAS)); 26/WA/0162 (Other Identifier: Wales Research Ethics Committee 1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No