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Completed

NCT Number: NCT01711892

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

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.

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Key information

Conditions

Prostatic Neoplasms Androgen Deprivation Therapy Behavior Exercise Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Site Prostatic Diseases Soccer Training Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Copenhagen, Centre of Integrated Rehabilitation of Cancer Patients

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Soccer training

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Beckett Foundation
  • Danish Cancer Society
  • Novo Nordisk A/S
  • TrygFonden, Denmark

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 22, 2012
Registry last updated
Apr 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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