Clinical trial NCT01711892: Health Effects of Soccer Training in Men With Prostate Cancer Receiving Androgen Deprivation Therapy
Official title: A Randomized Controlled Clinical Trial on the Effects of Recreational Soccer Training in Men With Prostate Cancer Receiving Androgen Deprivation Therapy: The FC Prostate Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Exercise
Soccer Training
Androgen Deprivation Therapy
Keywords: Prostatic Neoplasms
Prostate Cancer
Exercise
Soccer
Androgen Deprivation Therapy
Body Composition
Cardiovascular fitness
Bone Health
Health Related Quality of Life
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: Novo Nordisk A/S
name: TrygFonden, Denmark
name: Beckett Foundation
First posted: 2012-10-22
Enrollment: 57
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Androgen Deprivation Therapy (ADT) is standard treatment for locally advanced or advanced Prostate Cancer (PC).

The musculoskeletal toxicity associated with ADT is well established, leading to a decrease in muscle mass, increased fat percentage, weight gain, sexual dysfunction and increased risk of depression, fatigue, diabetes, cardiovascular disease and reduced quality of life.

Numerous studies have shown an association between physical activity, physical capacity and quality of life in cancer patients and recent epidemiological research suggest that regular, moderate-intensity physical activity may have a positive effect on survival in men with prostate cancer.

Within exercise physiology there is new evidence pointing to recreational soccer as a unique form of intermittent exercise that effectively stimulates aerobic and anaerobic energy delivery systems, leading to beneficial musculoskeletal, metabolic and cardiovascular adaptations of importance for health.

It is our overall hypothesis that 12 weeks of recreational soccer training 2-3 times per week will improve the health profile of PC patients receiving ADT treatment.


Eligibility criteria: Inclusion Criteria:

- Patients with locally advanced or advanced prostate cancer being treated with androgen deprivation therapy (S-testosterone \< 1.7) for at least 6 months at the time of inclusion

Exclusion Criteria:

* WHO performance level above 1,symptomatic cardiovascular disorders, osteoporosis (T-score below -2.5)

Primary outcomes:
measure: Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition.
timeFrame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Secondary outcomes:
measure: Bone Mineral Density
timeFrame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
measure: Cardiorespiratory fitness (Vo2 peak)
timeFrame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
measure: Patient reported outcomes
timeFrame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
measure: Heart function
timeFrame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
measure: Glucose tolerance
timeFrame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
measure: Postural Balance
timeFrame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
measure: Physical function
timeFrame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
measure: Hip to waist ratio
timeFrame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
measure: Muscle Strength
timeFrame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
measure: Blood markers
timeFrame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen, Centre of Integrated Rehabilitation of Cancer Patients
Study officials:
affiliation: University of Copenhagen
name: Mikael Rørth, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uth J, Hornstrup T, Christensen JF, Christensen KB, Jorgensen NR, Helge EW, Schmidt JF, Brasso K, Helge JW, Jakobsen MD, Andersen LL, Rorth M, Midtgaard J, Krustrup P. Football training in men with prostate cancer undergoing androgen deprivation therapy: activity profile and short-term skeletal and postural balance adaptations. Eur J Appl Physiol. 2016 Mar;116(3):471-80. doi: 10.1007/s00421-015-3301-y. Epub 2015 Nov 30.
citation: Uth J, Hornstrup T, Christensen JF, Christensen KB, Jorgensen NR, Schmidt JF, Brasso K, Jakobsen MD, Sundstrup E, Andersen LL, Rorth M, Midtgaard J, Krustrup P, Helge EW. Efficacy of recreational football on bone health, body composition, and physical functioning in men with prostate cancer undergoing androgen deprivation therapy: 32-week follow-up of the FC prostate randomised controlled trial. Osteoporos Int. 2016 Apr;27(4):1507-1518. doi: 10.1007/s00198-015-3399-0. Epub 2015 Nov 16.
citation: Bruun DM, Krustrup P, Hornstrup T, Uth J, Brasso K, Rorth M, Christensen JF, Midtgaard J. "All boys and men can play football": a qualitative investigation of recreational football in prostate cancer patients. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:113-21. doi: 10.1111/sms.12193.
citation: Uth J, Hornstrup T, Schmidt JF, Christensen JF, Frandsen C, Christensen KB, Helge EW, Brasso K, Rorth M, Midtgaard J, Krustrup P. Football training improves lean body mass in men with prostate cancer undergoing androgen deprivation therapy. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:105-12. doi: 10.1111/sms.12260.
citation: Krustrup P, Hansen PR, Nielsen CM, Larsen MN, Randers MB, Manniche V, Hansen L, Dvorak J, Bangsbo J. Structural and functional cardiac adaptations to a 10-week school-based football intervention for 9-10-year-old children. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:4-9. doi: 10.1111/sms.12277.
citation: Uth J, Schmidt JF, Christensen JF, Hornstrup T, Andersen LJ, Hansen PR, Christensen KB, Andersen LL, Helge EW, Brasso K, Rorth M, Krustrup P, Midtgaard J. Effects of recreational soccer in men with prostate cancer undergoing androgen deprivation therapy: study protocol for the 'FC Prostate' randomized controlled trial. BMC Cancer. 2013 Dec 13;13:595. doi: 10.1186/1471-2407-13-595.