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ExercisePhase 1/2NCT05156424

A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer

A Phase 1/2 study testing Exercise in people with Exercise and Prostate Cancer, run by Kira Murphy at 1 site in Ireland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Prostate cancer is the second most common cancer in men. Those in the intermediate/high-risk categories typically receive androgen deprivation therapy (ADT) and radiotherapy. ADT greatly reduces androgen production as prostate cancer is dependent on testosterone and dihydrotestosterone for its growth.The side effects… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Exercise, Prostate Cancer
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteIreland
Study dates
9 Sep 2021to 1 Mar 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >18 years of age with a histologically diagnosed prostate cancer
  • Prescribed ADT (Androgen deprivation Therapy)
  • Self-reported not to be partaking in regular exercise (structured aerobic or resistance training ≥ 2 sessions/week) in the past 3 months.
  • Medically cleared to exercise by their oncologist

Who cannot join

  • Prior exposure to ADT >12 months
  • Prior hypogonadism
  • Established metastatic bone disease
  • Established Osteoporosis
  • Musculoskeletal/Cardiovascular and/or Neurological disease that could put them at risk from exercise as judged by the attending physician.

Trial locations and contacts

1 site in 1 country.

Michael Dr Harrison, PhD contact

51302161 ext. +353

mharrison@wit.ie

Kira Ms Murphy, BSc (Hons) contact

murphyk@upmc.ie

Ireland1 site, 1 recruiting

  • WIT Sports Arena

    Waterford, Munster

    Kira Ms Murphy, BSc, +353 51 376827, murphyk@upmc.ie

    Michael Dr Harrison, PhD, +353 51 302161, mharrison@wit.ie

    Recruiting

Other trials in Ireland

About this study

Official title: A Comparison of Aerobic and Resistance Exercise for Counteracting the Adverse Effects of Androgen Deprivation Therapy in Men With Prostate Cancer

Prostate cancer is the second most common cancer in men. Those in the intermediate/high-risk categories typically receive androgen deprivation therapy (ADT) and radiotherapy. ADT greatly reduces androgen production as prostate cancer is dependent on testosterone and dihydrotestosterone for its growth.The side effects of ADT therapy are extensive and include changes in body composition (muscle loss, bone loss and fat gain), strength, mood, physical function, sexual function and increased cardiovascular risk and fatigue. Many of these side effects can be influenced by exercise training, both resistance training and aerobic training. However, the most appropriate exercise regime for men undergoing ADT has received little research attention.

Read the detailed description

Although many interventions for prostate survivors emphasise resistance exercise to maintain muscle mass and strength. Arguments could equally be made for programmes emphasising aerobic exercise for fatigue, anxiety, cardiovascular risk reduction and indeed overall survival.

Comparisons of programmes that emphasise each exercise mode are clearly required.

Therefore the overall purpose of this feasibility and pilot randomised control trial is to determine the feasibility and preliminary effectiveness of an aerobic emphasised exercise program (AE) verses a resistance emphasise exercise program (RE) in a rehabilitation setting, over 6 months, for prostate cancer men undergoing Androgen Deprivation Therapy (ADT).

Being tested
Exercise
Keywords
Prostate Cancer, Physical Fitness, Androgen Deprivation Therapy, Exercise, Cancer
Medical subject headings
Motor Activity, Prostatic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    An individualised, progressive and autoregulated exercise programme, supervised by a trained professional.

Study groups in NCT05156424
Study groupRoleWhat they receive
Aerobic Emphasised Exercise InterventionExperimentalThe intervention will comprise of 24 weeks of twice weekly supervised exercise sessions, emphasising aerobic exercise. To reflect a real-world setting, each group will experience both aerobic and resistance exercise, but there will be a 75%:25% predominant: subsidiary mode emphasis based on exercise duration within each session.
Receives: Other: Exercise
Resistance Emphasised Exercise InterventionExperimentalThe intervention will comprise of 24 weeks of twice weekly supervised exercise sessions, emphasising resistance exercise. To reflect a real-world setting, each group will experience both aerobic and resistance exercise, but there will be a 75%:25% predominant: subsidiary mode emphasis based on exercise duration of exercise within each session.
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility- recruitment rate (%)

    The recruitment rate will be established by comparing the number of potential participants approached and how many agreed to participate in the trial. This will be reported in percentage format.

    Measured: At study conclusion

  2. Feasibility- retention rate (%)

    Percentage of participants that completed the 24 week intervention compared to the number of participants randomised. This will be reported in percentage format.

    Measured: Intervention conclusion 24 weeks

  3. Feasibility- exercise program adherence through attendance %.

    The research team will report adherence to the exercise program through attendance of supervised classes. Attendance will be reported as a percentage.

    Measured: Throughout 24 week intervention

  4. Feasibility- exercise prescription adherence (% of modified sessions compared to attended exercise sessions)

    The research team will report adherence to the exercise prescription by reporting the number of modified sessions compared to attended exercise sessions. This will be reported as a percentage.

    Measured: Throughout 24 week intervention

  5. Feasibility- Adverse Event using CTCAE v4.0 grading system.

    The research team will report any adverse events in general or in relation to the exercise program using CTCAE v4.0 grading system.

    Measured: At study conclusion

  6. Feasibility- Patient satisfaction/acceptability through qualitative evaluation.

    Determined by qualitative evaluation, using semi structured interviews and exit surveys to evaluate the acceptability, experiences and feasibility of the intervention.

    Measured: Following intervention conclusion at 24 weeks

Secondary outcomes (27)

  1. General quality of life by questionnaire

    The RAND 36-Item Health Survey comprises of 36 questions and assesses eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scores range from 0-100. A higher score indicates a high quality of life and a favourable health status.

    Measured: At baseline, 8 weeks and 24 weeks (end of intervention)

  2. Cancer Specific quality of life by questionnaire

    The European Organisation for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) comprises of 30 questions, categorised into five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. The remaining six single-item (dyspnoea, appetite loss, sleep disturbance, constipation, diarrhoea and the financial impact) scales assess symptoms.

    Scores range from 0-100. A higher score for the functional scales and global health status indicates better functioning and quality of life. A higher score on the symptom and single-item scales denotes a high level of symptoms (i.e. a poor quality of life).

    Measured: At baseline, 8 weeks and 24 weeks (end of intervention)

  3. Prostate cancer specific quality of life by questionnaire

    The European Organisation for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-PR25) is a prostate cancer supplementary questionnaire module to be employed in conjunction with EORTC QLQ-C30. It comprises of five multi-item scales to assess sexual activity, sexual functioning, urinary symptoms, bowel symptoms and hormonal treatment-related symptoms and one single item assessing incontinence. Scores range from 0-100. A high score for the sexual activity and sexual functioning scales represents a high level of functioning. A high score for urinary, bowel and hormonal treatment related symptoms scales and incontinence aid item represents a high level of symptomatology.

    Measured: At baseline, 8 weeks and 24 weeks (end of intervention)

  4. Fatigue by questionnaire

    The Functional Assessment of Cancer Therapy - Fatigue (FACIT-Fatigue) questionnaire will be used to measure fatigue. Patients will score 13 fatigue items over the past 7 days on a scale (0 = not at all; 4 = very much), generating a total (0 - 52). A higher score indicates lower levels of fatigue.

    Measured: At baseline, 8 weeks and 24 weeks (end of intervention)

  5. Physical Activity (subjective) by questionnaire

    The Godin Leisure Time Exercise questionnaire will be used to calculate the average amount of strenuous, moderate and light exercise a participant performs in a typical 7 day period. A score of 24 units or more indicates the participant is active, 14-23 units indicates moderately active and less than 14 units suggests the participant is insufficiently active/sedentary.

    Measured: At baseline, 8 weeks and 24 weeks (end of intervention)

  6. Anthropometric assessment.

    Height will be measured in cm and body weight in kg, which will be combined to report BMI in kg/m(squared).

    Measured: At baseline and 24 weeks (end of intervention)

  7. Waist and Hip circumference analysis (cms)

    Waist circumference and hip circumference will be measured in centimetres. These two measurements will be used to calculate the participants waist: hip ratio. All measurements will be taken in duplication and averaged before data entry. If there is a substantial difference between the two measures, a third measurement will be taken.

    Measured: At baseline and 24 weeks (end of intervention)

  8. Body composition (fat mass) analysis using Dual Energy X Ray Absorptiometry (Dexa)

    Fat mass (grams and percentage) will be assessed using DEXA (Horizon W, Hologic, 304492M). Participants will be scanned after an overnight fast and will be instructed to regulate their water/fluid intake in the days leading up to the scan, so they are adequately hydrated. All scans will be completed at the same time as much as possible to account for physiological changes in body composition throughout the day.

    Measured: At baseline and 24 weeks (end of intervention)

  9. Body composition (fat and lean mass) analysis using Dual Energy X Ray Absorptiometry (Dexa)

    Lean mass (grams and percentage) will be assessed using DEXA (Horizon W, Hologic, 304492M). Participants will be scanned after an overnight fast and will be instructed to regulate their water/fluid intake in the days leading up to the scan, so they are adequately hydrated. All scans will be completed at the same time as much as possible to account for physiological changes in body composition throughout the day.

    Measured: At baseline and 24 weeks (end of intervention)

  10. Bone density (BMD) measurement

    Whole body bone Density will be measured using DEXA (Horizon W, Hologic, 304492M). BMD will be measured in g/cm(squared) and used to calculate a T-score (SD). A T-score shows how much a participant's BMD is higher or lower than the BMD of a healthy 30 year old adult and is the score most commonly used to diagnose low BMD.

    Measured: At baseline and 24 weeks (end of intervention)

  11. Visceral fat area (VAT Area) in cm(squared)

    Visceral fat area will be assessed using DEXA (Horizon W, Hologic, 304492M). It will be measured in cm(squared). Participants will be scanned after an overnight fast and will be instructed to regulate their water/fluid intake in the days leading up to the scan, so they are adequately hydrated. All scans will be completed at the same time as much as possible to account for physiological changes in body composition throughout the day

    Measured: At baseline and 24 weeks (end of intervention)

  12. Atrial stiffness measured by a Pulse Wave Velocity Assessment (m/s)

    A carotid-femoral pulse wave velocity test will be performed to assess arterial stiffness. It will be measured in meters per seconds (m/s). This will be performed as per manufactural instructions using a Complior, Alam medical device. Measurements will be taken in duplicate and the mean recorded, with a third measurement taken if difference between the two measurements is more than 0.5 m/s and median recorded.

    Measured: At baseline and 24 weeks (end of intervention)

  13. Blood pressure (mmHg)

    Blood pressure (diastolic and systolic) measured at rest. Blood pressure will be taken according to the American Heart Association's (AHA) guidelines. At least two readings and the average recorded. Additional readings will be taken if the difference between the two reading exceeds 5mm Hg.

    Measured: At baseline and 24 weeks (end of intervention)

  14. Cardiovascular Fitness

    Cardiovascular fitness will be determined by a submaximal incremental treadmill test using a modified Bruce protocol. The test will be scored by the time (minutes and seconds) taken to test completion. A longer time to completion means superior cardiovascular fitness.

    Measured: 0(baseline), 8 weeks and 6 months (end of intervention)

  15. Peak torque/power for knee extension and flexion

    An isokinetic dynamometry for knee extension and flexion will also be performed on a Biodex (Advantage BX™ Software Update v5.3.00) to measure peak torque (n.M) and power, using a similar protocol as previously used in cancer patients.

    Measured: At baseline and 24 weeks (end of intervention)

  16. Lower limb strength [Leg Press]

    Leg press 1 repetition maximum will be measured in kilograms (kg). A 1 repetition maximum is defined as the highest load that can be lifted through full range of movement for one time.

    Measured: At baseline and 24 weeks (end of intervention)

  17. Upper limb strength [Chest Press]

    Chest press 1 repetition maximum will be measured in kilograms (kg). A 1 repetition maximum is defined as the highest load that can be lifted through full range of movement for one time.

    Measured: At baseline and 24 weeks (end of intervention)

  18. Functional Ability Assessment (Timed up and go)

    The timed up and go assess the time (in seconds) it takes for a person to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees. It assesses mobility, balance, walking ability and falls risk in older adults. A lower score indicates better physical function.

    Measured: At baseline, 8 weeks and 24 weeks (end of intervention)

  19. Functional Ability Assessment (Sit to stand)

    Sit to stand assesses the maximal repetitions a participant can stand up from a chair in 30 seconds. A higher score indicates better physical function.

    Measured: At baseline, 8 weeks and 24 weeks (end of intervention)

  20. Functional Ability Assessment (Grip test)

    A hand-held dynamometry will be used to measure grip strength for each arm. this is a measure of upper body strength and a higher score suggests better upper body strength

    Measured: At baseline, 8 weeks and 24 weeks (end of intervention)

  21. Functional Ability Assessment (Bess Balance test)

    The Balance Error Scoring System is an objective measure of assessing static postural stability. A lower score= better balance and reduced falls risk.

    Measured: At baseline, 8 weeks and 24 weeks (end of intervention)

  22. Functional Ability Assessment (6 minute walk test)

    A 6-min walk test measured the maximal meters walked in six minutes. A higher score indicated superior aerobic endurance and capacity.

    Measured: At baseline, 8 weeks and 24 weeks (end of intervention)

  23. Functional Ability Assessment (Sit and reach)

    The sit and reach test measures linear flexibility. The score is the most distant point (cm) reached with the fingertips. A higher score indicates better flexibility

    Measured: At baseline, 8 weeks and 24 weeks (end of intervention)

  24. Biomarker Analysis: Blood lipids (mmol/L)

    Blood lipids (total cholesterol, triglycerides, LDH and HDL) will be analysed Fasting blood will be taken from all participants using a standard venipuncture technique. All bloods will be analyzed in a certified clinical lab.

    Measured: At baseline and 24 weeks (end of intervention)

  25. Biomarker Analysis: Glucose (mmol/L)

    Fasted blood will be used to measure blood glucose (mmol/L),

    Measured: At baseline and 24 weeks (end of intervention)

  26. Biomarker Analysis: Insulin (mIU/L)

    Fasted blood will be used to measure blood insulin (mIU/L)

    Measured: At baseline and 24 weeks (end of intervention)

  27. Biomarker Analysis: C-Reactive Protein (CRP)

    Fasted blood will be used to measure C-reactive protein (mg/dL).

    Measured: At baseline and 24 weeks (end of intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2021
  2. Study start9 Sep 2021
  3. Primary completion1 Mar 2023 (estimated)
  4. Study completion1 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Pilot randomised control trial
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05156424
Sponsor's protocol ID
EBPPG/2020/103
Status last verified
Dec 2021
First submitted
31 Oct 2021
Last updated
14 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cancer statistics. Viewed 21st February 2020. https://www.cancer.ie/cancer-information-and-support/cancer-information/about-cancer/cancer-statistics

  • Hormone Therapy for Prostate Cancer. Viewed on the 20th January 2020 https://www.cancer.org/cancer/prostate-cancer/treating/hormone-therapy.html

  • Bylow K, Mohile SG, Stadler WM, Dale W. Does androgen-deprivation therapy accelerate the development of frailty in older men with prostate cancer?: a conceptual review. Cancer. 2007 Dec 15;110(12):2604-13. doi: 10.1002/cncr.23084.

    PubMed 17960609

  • Norris MK, Bell GJ, North S, Courneya KS. Effects of resistance training frequency on physical functioning and quality of life in prostate cancer survivors: a pilot randomized controlled trial. Prostate Cancer Prostatic Dis. 2015 Sep;18(3):281-7. doi: 10.1038/pcan.2015.28. Epub 2015 Jun 16.

    PubMed 26078203

  • Fairman CM, Kendall KL, Hart NH, Taaffe DR, Galvao DA, Newton RU. The potential therapeutic effects of creatine supplementation on body composition and muscle function in cancer. Crit Rev Oncol Hematol. 2019 Jan;133:46-57. doi: 10.1016/j.critrevonc.2018.11.003. Epub 2018 Nov 12.

    PubMed 30661658

  • Winters-Stone KM, Lyons KS, Dobek J, Dieckmann NF, Bennett JA, Nail L, Beer TM. Benefits of partnered strength training for prostate cancer survivors and spouses: results from a randomized controlled trial of the Exercising Together project. J Cancer Surviv. 2016 Aug;10(4):633-44. doi: 10.1007/s11764-015-0509-0. Epub 2015 Dec 29.

    PubMed 26715587

  • Nilsen TS, Raastad T, Skovlund E, Courneya KS, Langberg CW, Lilleby W, Fossa SD, Thorsen L. Effects of strength training on body composition, physical functioning, and quality of life in prostate cancer patients during androgen deprivation therapy. Acta Oncol. 2015 Nov;54(10):1805-13. doi: 10.3109/0284186X.2015.1037008. Epub 2015 Apr 30.

    PubMed 25927504

  • Newton RU, Kenfield SA, Hart NH, Chan JM, Courneya KS, Catto J, Finn SP, Greenwood R, Hughes DC, Mucci L, Plymate SR, Praet SFE, Guinan EM, Van Blarigan EL, Casey O, Buzza M, Gledhill S, Zhang L, Galvao DA, Ryan CJ, Saad F. Intense Exercise for Survival among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL-GAP4): a multicentre, randomised, controlled phase III study protocol. BMJ Open. 2018 May 14;8(5):e022899. doi: 10.1136/bmjopen-2018-022899.

    PubMed 29764892

  • Kilgour RD, Vigano A, Trutschnigg B, Hornby L, Lucar E, Bacon SL, Morais JA. Cancer-related fatigue: the impact of skeletal muscle mass and strength in patients with advanced cancer. J Cachexia Sarcopenia Muscle. 2010 Dec;1(2):177-185. doi: 10.1007/s13539-010-0016-0. Epub 2010 Dec 17.

    PubMed 21475694

  • Van Bortel LM, Laurent S, Boutouyrie P, Chowienczyk P, Cruickshank JK, De Backer T, Filipovsky J, Huybrechts S, Mattace-Raso FU, Protogerou AD, Schillaci G, Segers P, Vermeersch S, Weber T; Artery Society; European Society of Hypertension Working Group on Vascular Structure and Function; European Network for Noninvasive Investigation of Large Arteries. Expert consensus document on the measurement of aortic stiffness in daily practice using carotid-femoral pulse wave velocity. J Hypertens. 2012 Mar;30(3):445-8. doi: 10.1097/HJH.0b013e32834fa8b0.

    PubMed 22278144

  • Flack JM, Adekola B. Blood pressure and the new ACC/AHA hypertension guidelines. Trends Cardiovasc Med. 2020 Apr;30(3):160-164. doi: 10.1016/j.tcm.2019.05.003. Epub 2019 May 15.

    PubMed 31521481

  • Murphy K, Kehoe B, Denieffe S, Hacking D, Fairman CM, Harrison M. Comparing aerobic and resistance exercise emphasis during androgen deprivation and radiation therapy for prostate cancer: A randomised feasibility trial. Support Care Cancer. 2025 Jun 20;33(7):601. doi: 10.1007/s00520-025-09650-z.

    PubMed 40540036

  • Murphy K, Kehoe B, Denieffe S, McGrath A, Hacking D, Fairman CM, Harrison M. 'Just because I have prostate cancer doesn't mean that I can't do things' - men's experiences of the acceptability of an exercise intervention for prostate cancer during treatment. BMC Cancer. 2024 Aug 2;24(1):949. doi: 10.1186/s12885-024-12687-8.

    PubMed 39095735

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Exercise in people with Exercise and Prostate Cancer, run by Kira Murphy at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michael Dr Harrison, PhD (51302161 ext. +353, mharrison@wit.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility- recruitment rate (%) (time frame: At study conclusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05156424, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.

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