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NCT Number: NCT07724080

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

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

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Key information

Conditions

Prostate Cancer Atrophy Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Muscle Loss Muscular Atrophy Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supervised Resistance Exercise Programme

Other

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 outcomes

  1. Change in Resting Interleukin-7 (IL-7) Concentration

    Time frame: 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 outcomes

  1. Change in Frequencies of Resting Immune Cell Phenotypes

    Time frame: 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.

  2. Acute Circulating IL-7 Response to a Single Bout of Exercise

    Time frame: 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.

  3. Change in Total Lean Mass

    Time frame: Baseline and 12 weeks

    Measured via Dual-Energy X-ray Absorptiometry (DEXA) to evaluate changes in lean tissue.

  4. Change in Total Fat Mass

    Time frame: Baseline and 12 weeks

    Measured via Dual-Energy X-ray Absorptiometry (DEXA) to evaluate changes in body fat.

  5. Change in Local Muscle Cross-Sectional Area (CSA)

    Time frame: Baseline and 12 weeks

    Local muscle cross-sectional area (CSA) assessed via peripheral Quantitative Computed Tomography (pQCT) to assess changes in specific muscle size.

  6. Change in Handgrip Strength

    Time frame: Baseline, 12 weeks

    Measured using a hand dynamometer to assess upper-body isometric strength

  7. Change in 30-Second Sit-to-Stand Test Performance

    Time frame: Baseline and 12 weeks

    Evaluated by the number of sit-to-stand repetitions completed in 30 seconds to assess lower-body functional strength.

  8. Change in Timed Up and Go (TUG) Test Performance

    Time frame: Baseline and 12 weeks

    Assessed using the Timed Up and Go Test (TUG) to evaluate changes in functional mobility and balance.

  9. Change in Leg Press Peak Power Output

    Time frame: Baseline and 12 weeks

    Assessed using a Keiser leg press to determine peak power output

  10. Change in Leg Press One-Repetition Maximum (1RM)

    Time frame: Baseline and 12 weeks

    Assessed using a Keiser leg press to determine 1-repetition maximum (1RM).

  11. Change in Glycated Haemoglobin (HbA1c)

    Time frame: Baseline and 12 weeks

    Analyzed from resting, fasting blood samples to monitor long-term glycemic control.

  12. Change in Fasting Insulin

    Time frame: Baseline and 12 weeks

    Analyzed from resting, fasting blood samples to evaluate insulin levels and metabolic health

  13. Change in Fasting Glucose

    Time frame: Baseline and 12 weeks

    Analyzed from resting, fasting blood samples to evaluate baseline glycemic control

  14. Change in C-Reactive Protein (CRP)

    Time frame: Baseline and 12 weeks

    Analyzed from resting, fasting blood samples to assess baseline systemic inflammation.

  15. Change in Cancer-Specific Quality of Life (EORTC QLQ-C30)

    Time frame: 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.

  16. Change in Prostate Cancer-Specific Symptoms (EORTC QLQ-PR25)

    Time frame: 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).

  17. Change in Fatigue Severity (FACIT-Fatigue)

    Time frame: 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).

  18. Uptake and Retention Rates

    Time frame: 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.

  19. Incidence of Adverse Events

    Time frame: Throughout the 12-week intervention period

    Total number and percentage of participants experiencing adverse events, systematically tracked and evaluated for seriousness and causality.

  20. Exercise Session Attendance Rate

    Time frame: 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.

  21. Resistance Exercise Dose Adherence

    Time frame: Throughout the 12-week intervention period

    Calculated as the percentage of total prescribed exercise sets completed by the participants in the intervention group

  22. Average Session Rate of Perceived Exertion (RPE)

    Time frame: 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.

  23. Frequency of Exercise Dose Reductions

    Time frame: 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.

  24. Frequency of Exercise Interruptions

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fernando Alonso

CONTACT

[email protected]

+447760199388

Sponsors and collaborators

Lead sponsor

University of Bath

Other

Collaborators

  • Royal United Hospitals Bath NHS Foundation Trust

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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