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Prostatic NeoplasmsNCT01711892

Health Effects of Soccer Training in Men With Prostate Cancer Receiving Androgen Deprivation Therapy

A study testing Soccer training in people with Prostatic Neoplasms and Exercise, run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years, men only
Conditions the study is for
Prostatic Neoplasms, Exercise, Soccer Training
What is being tested?
Soccer training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteDenmark
Study dates
Mar 2012to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • University of Copenhagen, Centre of Integrated Rehabilitation of Cancer Patients

    Copenhagen, Copenhagen, 2100

Other trials in Denmark

About this study

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

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.

Read more

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.

Being tested
Soccer training
Keywords
Prostatic Neoplasms, Prostate Cancer, Exercise, Soccer, Androgen Deprivation Therapy, Body Composition, Cardiovascular fitness, Bone Health, Health Related Quality of Life
Medical subject headings
Prostatic Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Soccer trainingBehavioural

Study groups in NCT01711892
Study groupRoleWhat they receive
Soccer TrainingActive comparator12 weeks of soccer training. (2 times per week for the first 8 weeks and 3 times per week in the last 4 weeks. Training will consist of 15 minutes warm-up and 2 x 15 minutes matches for the first 4 weeks and of 15 minutes warm-up and 3 x 15 minutes matches for the last 8 weeks). After 12 weeks assessments participants in the intervention group will continue bi-weekly supervised training for additional 20 weeks at the end of which tests will be repeated.
Receives: Behavioral: Soccer training
Control groupNo interventionUsual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition.

    Changes in body composition assessed by Dual-energy X-ray absorptiometry(DXA)scan

    Measured: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)

Secondary outcomes (10)

  1. Bone Mineral Density

    Measured: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)

  2. Cardiorespiratory fitness (Vo2 peak)

    Change in maximal oxygen consumption (Vo2 peak) assessed directly during an incremental test on a cycle ergometer from baseline to post-intervention (12 weeks) and follow-up (32 weeks).

    Measured: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)

  3. Patient reported outcomes

    Changes in Psychological distress (Hospital Anxiety and Depression Scale, HADS), Quality of Life (EORTC QLQ C-30), general well-being (SF-36), disease specific symptoms and side-effects (EORTC PR-25)from baseline to post-intervention (12 weeks) and follow-up (32 weeks)

    Measured: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)

  4. Heart function

    Changes in Heart function measured by Echocardiography from baseline to post-intervention (12 weeks) and follow-up (32 weeks)

    Measured: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)

  5. Glucose tolerance

    Oral Glucose Tolerance Test

    Measured: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)

  6. Postural Balance

    Assessed standing on a force platform with feet in bilateral, unilateral and tandem position. Additionally assessed with a modified Flamingo balance test.

    Measured: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)

  7. Physical function

    Physical function will be assessed with sit to stand test (30s), stair climbing test and Counter Movement Jump (jump height)

    Measured: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)

  8. Hip to waist ratio

    Hip and waist circumference will be measured and the hip to waist ratio will be calculated

    Measured: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)

  9. Muscle Strength

    Muscle strength will be assessed with the 1Repetition Maximum test for knee extensors

    Measured: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)

  10. Blood markers

    Markers of inflammation and bone metabolism will be obtained after overnight fasting

    Measured: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01711892
Sponsor's protocol ID
CIRE-04
Status last verified
Apr 2014
First submitted
17 Oct 2012
Last updated
21 Apr 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26620651

  • 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.

    PubMed 26572756

  • 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.

    PubMed 24944135

  • 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.

    PubMed 24944134

  • 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.

    PubMed 24944128

  • 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.

    PubMed 24330570

Questions about this trial

What is this clinical trial studying?

A study testing Soccer training in people with Prostatic Neoplasms and Exercise, run by University of Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition. (time frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01711892, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.

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