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

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ClinicalTrials.gov Identifier: NCT01711892
Recruitment Status : Completed
First Posted : October 22, 2012
Last Update Posted : April 21, 2014
Sponsor:
Collaborators:
Danish Cancer Society
Novo Nordisk A/S
TrygFonden, Denmark
Beckett Foundation
Information provided by (Responsible Party):
Jacob Uth, University of Copenhagen

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.


Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Exercise Soccer Training Androgen Deprivation Therapy Behavioral: Soccer training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : March 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: Soccer Training
12 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.
Behavioral: Soccer training
No Intervention: Control group
Usual care



Primary Outcome Measures :
  1. 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) ]
    Changes in body composition assessed by Dual-energy X-ray absorptiometry(DXA)scan


Secondary Outcome Measures :
  1. Bone Mineral Density [ Time Frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) ]
  2. Cardiorespiratory fitness (Vo2 peak) [ Time Frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) ]
    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).

  3. Patient reported outcomes [ Time Frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) ]
    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)

  4. Heart function [ Time Frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) ]
    Changes in Heart function measured by Echocardiography from baseline to post-intervention (12 weeks) and follow-up (32 weeks)

  5. Glucose tolerance [ Time Frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) ]
    Oral Glucose Tolerance Test

  6. Postural Balance [ Time Frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) ]
    Assessed standing on a force platform with feet in bilateral, unilateral and tandem position. Additionally assessed with a modified Flamingo balance test.

  7. Physical function [ Time Frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) ]
    Physical function will be assessed with sit to stand test (30s), stair climbing test and Counter Movement Jump (jump height)

  8. Hip to waist ratio [ Time Frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) ]
    Hip and waist circumference will be measured and the hip to waist ratio will be calculated

  9. Muscle Strength [ Time Frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) ]
    Muscle strength will be assessed with the 1Repetition Maximum test for knee extensors

  10. Blood markers [ Time Frame: Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) ]
    Markers of inflammation and bone metabolism will be obtained after overnight fasting



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01711892


Locations
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Denmark
University of Copenhagen, Centre of Integrated Rehabilitation of Cancer Patients
Copenhagen, Denmark, 2100
Sponsors and Collaborators
University of Copenhagen
Danish Cancer Society
Novo Nordisk A/S
TrygFonden, Denmark
Beckett Foundation
Investigators
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Principal Investigator: Mikael Rørth, Professor University of Copenhagen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jacob Uth, Project manager, Ph.d student, Master of Health Science, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01711892     History of Changes
Other Study ID Numbers: CIRE-04
First Posted: October 22, 2012    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: April 2014
Keywords provided by Jacob Uth, University of Copenhagen:
Prostatic Neoplasms
Prostate Cancer
Exercise
Soccer
Androgen Deprivation Therapy
Body Composition
Cardiovascular fitness
Bone Health
Health Related Quality of Life
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs