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

NCT ID: NCT05156424

Last Updated: 2021-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-09

Study Completion Date

2023-03-01

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Exercise Prostate Cancer

Keywords

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Prostate Cancer Physical Fitness Androgen Deprivation Therapy Exercise Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pilot randomised control trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Aerobic Emphasised Exercise Intervention

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

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

Resistance Emphasised Exercise Intervention

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

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

Interventions

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Exercise

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* \>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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Irish Research Council

OTHER

Sponsor Role collaborator

University of Pittsburgh Medical Center

OTHER

Sponsor Role collaborator

Waterford Instituate of Technology

OTHER

Sponsor Role collaborator

Kira Murphy

OTHER

Sponsor Role lead

Responsible Party

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Kira Murphy

Research Coordinator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michael Dr Harrison, PhD

Role: PRINCIPAL_INVESTIGATOR

Waterford Institute of Technology

Locations

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WIT Sports Arena

Waterford, Munster, Ireland

Site Status RECRUITING

Countries

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Ireland

Central Contacts

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Michael Dr Harrison, PhD

Role: CONTACT

Phone: 51302161

Email: [email protected]

Kira Ms Murphy, BSc (Hons)

Role: CONTACT

Email: [email protected]

Facility Contacts

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Kira Ms Murphy, BSc

Role: primary

Michael Dr Harrison, PhD

Role: backup

References

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

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 17960609 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26078203 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30661658 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26715587 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25927504 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29764892 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21475694 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22278144 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31521481 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40540036 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39095735 (View on PubMed)

Other Identifiers

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EBPPG/2020/103

Identifier Type: -

Identifier Source: org_study_id