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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Prostatic Neoplasms, Exercise, Soccer Training, Androgen Deprivation Therapy

Intervention / Treatment
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* Behavioral: Soccer training


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Soccer Training<br>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<br> <br> |
| No Intervention: Control group<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density |  | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | 
| 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). | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | 
| 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) | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | 
| Heart function | Changes in Heart function measured by Echocardiography from baseline to post-intervention (12 weeks) and follow-up (32 weeks) | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | 
| Glucose tolerance | Oral Glucose Tolerance Test | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | 
| Postural Balance | Assessed standing on a force platform with feet in bilateral, unilateral and tandem position. Additionally assessed with a modified Flamingo balance test. | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | 
| Physical function | Physical function will be assessed with sit to stand test (30s), stair climbing test and Counter Movement Jump (jump height) | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | 
| Hip to waist ratio | Hip and waist circumference will be measured and the hip to waist ratio will be calculated | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | 
| Muscle Strength | Muscle strength will be assessed with the 1Repetition Maximum test for knee extensors | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | 
| Blood markers | Markers of inflammation and bone metabolism will be obtained after overnight fasting | Change from baseline to post intervention (12 weeks) and follow-up (32 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatic Neoplasms, Prostate Cancer, Exercise, Soccer, Androgen Deprivation Therapy, Body Composition, Cardiovascular fitness, Bone Health, Health Related Quality of Life