Clinical trial NCT02046837: An Exercise Trial and Economic Analysis in Men With Prostate Cancer
Official title: A Pilot RCT and Economic Analysis of Three Exercise Delivery Methods in Men With Prostate Cancer on ADT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate cancer
Exercise
Elderly
Quality of life
Fatigue
Physical fitness
Adherence
Cost-effectiveness
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 59
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Prostate Cancer (PC) affects 1 in 7 men. Nearly half of those diagnosed with PC will receive androgen deprivation therapy (ADT) as part of their treatment. ADT is good at managing PC but has many side effects. Researchers have shown that exercise, specifically one-on-one supervised exercise improves many of the side effects of ADT. However, exercise programs for men on ADT are not widely available. More questions need to be answered in order for exercise programs to become part of PC treatment. First, can programs that require fewer resources, such as group-exercise or home-based exercise, also improve ADT side-effects? Second, do exercise-related benefits continue beyond the structured exercise program? And what makes people continue exercising? Third, which exercise program is most cost-effective?

In this study, the investigators will compare: (a) group supervised in-centre; (b) home-based supported; and (c) 1:1 supervised in-centre exercise programs to see which program is most effective for men with PC on ADT. The investigators will also look at what motivates people to continue to exercise both during a structured program and after the program is complete and will examine which exercise program is most cost-effective.

The investigators will ask men with PC on ADT that are being treated at either Princess Margaret Cancer Centre in Toronto or the Tom Baker Cancer Centre in Calgary to participate in the study. When a patient agrees to participate, he will be randomly placed in 1 of the 3 exercise programs. All programs will include the same type of exercises (aerobic, resistance and flexibility) and all participants will exercise 4-5 days per week for 30 minutes per day (as tolerated) for the length of the program (6 months). The investigators will look at how men with PC on ADT respond to the exercise program by measuring quality of life (QOL), fatigue and different physical measures before, during, and after the exercise program.

Although the investigators know that supervised one-on-one exercise is most effective at improving ADT side-effects, it is unknown if other forms of exercise are just as beneficial and more financially responsible. This study will allow the investigators to begin to answer these questions so that structured exercise programs become a regular part of PC treatment.


Eligibility criteria: Inclusion Criteria:

* confirmed prostate cancer
* starting or continuing on ADT for at least 6 months
* fluent in English
* able to provide consent
* live close to a study centre
* screened with the Physical Activity Readiness Questionnaire (PAR-Q+ or PARmed-X) to ensure safe exercise participation OR receive medical clearance by attending physician

Exclusion Criteria:

* already meeting guidelines for moderate to vigorous physical activity (MVPA) as defined by the Canadian Physical Activity Guidelines (greater than or equal to 150 minutes of MVPA per week)
* conditions that would interfere with ability to participate

Primary outcomes:
measure: Change from baseline in health-related quality of life (QOL) at 3, 6, 9, and 12 months
timeFrame: Every 3 months for 1 year
Secondary outcomes:
measure: Change from baseline in quality of life (QOL) at 3, 6, 9, and 12 months
timeFrame: Every 3 months for 1 year
measure: Change from baseline in fatigue at 3, 6, 9, and 12 months
timeFrame: Every 3 months for 1 year
measure: Change from baseline in aerobic fitness (VO2peak) at 3, 6, 9, and 12 months
timeFrame: Every 3 months for 1 year
measure: Change from baseline in musculoskeletal fitness at 3, 6, 9, and 12 months
timeFrame: Every 3 months for 1 year
measure: Change from baseline in grip strength at 3, 6, 9, and 12 months
timeFrame: Every 3 months for 1 year
measure: Change from baseline in body composition at 6 and 12 months
timeFrame: Every 6 months for 1 year
measure: Change from baseline in bone mineral density at 12 months
timeFrame: Baseline and 1 year.
measure: Change from baseline in biological outcomes at 6 and 12 months
timeFrame: Every 6 months for 1 year
measure: Change from baseline in adherence predictors at 3, 6, 9, and 12 months
timeFrame: Every 3 months for 1 year
measure: Change from baseline in cost-effectiveness at 3, 6, 9, and 12 months
timeFrame: Every 3 months for 1 year
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary/Tom Baker Cancer Centre
state: Alberta
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Shabbir MH Alibhai, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Papadopoulos E, Leach HJ, Tomlinson G, Durbano S, Danyluk JM, Sabiston CM, Mina DS, Alibhai SMH, Culos-Reed SN. Factors predicting gains in moderate-to-vigorous physical activity in prostate cancer survivors on androgen deprivation therapy. Support Care Cancer. 2022 Nov;30(11):9011-9018. doi: 10.1007/s00520-022-07300-2. Epub 2022 Aug 10.
citation: Alibhai SMH, Santa Mina D, Ritvo P, Tomlinson G, Sabiston C, Krahn M, Durbano S, Matthew A, Warde P, O'Neill M, Timilshina N, Segal R, Culos-Reed N. A phase II randomized controlled trial of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy. BMC Cancer. 2019 Jan 3;19(1):2. doi: 10.1186/s12885-018-5189-5.
citation: Alibhai SM, Santa Mina D, Ritvo P, Sabiston C, Krahn M, Tomlinson G, Matthew A, Segal R, Warde P, Durbano S, O'Neill M, Culos-Reed N. A phase II RCT and economic analysis of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy. BMC Cancer. 2015 Apr 25;15:312. doi: 10.1186/s12885-015-1316-8.