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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05156424
• Other study ID #: EBPPG/2020/103
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 9, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: December 2021
• Source: Waterford Instituate of Technology
• Contact: Michael Dr Harrison, PhD
• Phone: 51302161
• Email: mharrison[@]wit.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Exercise
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Exercise
An individualised, progressive and autoregulated exercise programme, supervised by a trained professional.

Locations

Country	Name	City	State
Ireland	WIT Sports Arena	Waterford	Munster

Sponsors (4)

Lead Sponsor	Collaborator
Kira Murphy	Irish Research Council, University of Pittsburgh Medical Center, Waterford Instituate of Technology

Country where clinical trial is conducted

Ireland, 

References & Publications (11)

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. Review. — View Citation

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

Fairman CM, Kendall KL, Hart NH, Taaffe DR, Galvão 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. Review. — View Citation

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. Review. — View Citation

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

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. Epub 2010 Dec 17. — View Citation

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, Galvão 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. — View Citation

Nilsen TS, Raastad T, Skovlund E, Courneya KS, Langberg CW, Lilleby W, Fosså 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	At baseline, 8 weeks and 24 weeks (end of intervention)
Secondary	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).	At baseline, 8 weeks and 24 weeks (end of intervention)
Secondary	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.	At baseline, 8 weeks and 24 weeks (end of intervention)
Secondary	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.	At baseline, 8 weeks and 24 weeks (end of intervention)
Secondary	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.	At baseline, 8 weeks and 24 weeks (end of intervention)
Secondary	Anthropometric assessment.	Height will be measured in cm and body weight in kg, which will be combined to report BMI in kg/m(squared).	At baseline and 24 weeks (end of intervention)
Secondary	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.	At baseline and 24 weeks (end of intervention)
Secondary	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.	At baseline and 24 weeks (end of intervention)
Secondary	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.	At baseline and 24 weeks (end of intervention)
Secondary	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.	At baseline and 24 weeks (end of intervention)
Secondary	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	At baseline and 24 weeks (end of intervention)
Secondary	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.	At baseline and 24 weeks (end of intervention)
Secondary	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.	At baseline and 24 weeks (end of intervention)
Secondary	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.	0(baseline), 8 weeks and 6 months (end of intervention)
Secondary	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.	At baseline and 24 weeks (end of intervention)
Secondary	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.	At baseline and 24 weeks (end of intervention)
Secondary	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.	At baseline and 24 weeks (end of intervention)
Secondary	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.	At baseline, 8 weeks and 24 weeks (end of intervention)
Secondary	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.	At baseline, 8 weeks and 24 weeks (end of intervention)
Secondary	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	At baseline, 8 weeks and 24 weeks (end of intervention)
Secondary	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.	At baseline, 8 weeks and 24 weeks (end of intervention)
Secondary	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.	At baseline, 8 weeks and 24 weeks (end of intervention)
Secondary	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	At baseline, 8 weeks and 24 weeks (end of intervention)
Secondary	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.	At baseline and 24 weeks (end of intervention)
Secondary	Biomarker Analysis: Glucose (mmol/L)	Fasted blood will be used to measure blood glucose (mmol/L),	At baseline and 24 weeks (end of intervention)
Secondary	Biomarker Analysis: Insulin (mIU/L)	Fasted blood will be used to measure blood insulin (mIU/L)	At baseline and 24 weeks (end of intervention)
Secondary	Biomarker Analysis: C-Reactive Protein (CRP)	Fasted blood will be used to measure C-reactive protein (mg/dL).	At baseline and 24 weeks (end of intervention)