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

NCT05156424 | Unknown Phase 1

• 1 other identifier: EBPPG/2020/103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Exercise; Prostate Cancer

Keywords

Prostate Cancer; Physical Fitness; Androgen Deprivation Therapy; Exercise; Cancer

Outcome Measures

Primary Outcomes (6)

• 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.

  At study conclusion

• 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.

  Intervention conclusion 24 weeks

• 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.

  Throughout 24 week intervention

• 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.

  Throughout 24 week intervention

• 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.

  At study conclusion

• 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.

  Following intervention conclusion at 24 weeks

Secondary Outcomes (27)

• General quality of life by questionnaire

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

• Cancer Specific quality of life by questionnaire

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

• Prostate cancer specific quality of life by questionnaire

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

• Fatigue by questionnaire

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

• Physical Activity (subjective) by questionnaire

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

Study Arms (2)

Aerobic Emphasised Exercise Intervention

EXPERIMENTAL

The 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.

Other: Exercise

Resistance Emphasised Exercise Intervention

EXPERIMENTAL

The 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.

Other: Exercise

Interventions

Exercise OTHER

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

Aerobic Emphasised Exercise Intervention; Resistance Emphasised Exercise Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Men diagnosed with prostate cancer will be recruited.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kira Murphy: lead
• Irish Research Council: collaborator
• University of Pittsburgh Medical Center: collaborator
• Waterford Instituate of Technology: collaborator

Study Sites (1)

WIT Sports Arena

Waterford, Munster, Ireland

RECRUITING

Related Publications (13)

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 17960609 BACKGROUND

• 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.

  PMID: 26078203 BACKGROUND

• 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.

  PMID: 30661658 BACKGROUND

• 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.

  PMID: 26715587 BACKGROUND

• 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.

  PMID: 25927504 BACKGROUND

• 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.

  PMID: 29764892 BACKGROUND

• 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.

  PMID: 21475694 BACKGROUND

• 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.

  PMID: 22278144 BACKGROUND

• 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.

  PMID: 31521481 BACKGROUND

• 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.

  PMID: 40540036 DERIVED

• 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.

  PMID: 39095735 DERIVED

MeSH Terms

Conditions

Motor Activity; Prostatic Neoplasms; Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Michael Dr Harrison, PhD

  Waterford Institute of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Dr Harrison, PhD

CONTACT

51302161; mharrison@wit.ie

Kira Ms Murphy, BSc (Hons)

CONTACT

murphyk@upmc.ie

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Coordinator

Model Details: Pilot randomised control trial

Study Record Dates

• First Submitted: October 31, 2021
• First Posted: December 14, 2021
• Study Start: September 9, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: December 14, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)