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

Exercise Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711892
• Other study ID #: CIRE-04
• Status: Completed
• Phase: N/A
• First received: October 17, 2012
• Last updated: April 16, 2014
• Start date: March 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical 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, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Androgen Deprivation Therapy
• Exercise
• Prostatic Neoplasms
• Soccer Training

Intervention

Behavioral:
• Soccer training

Locations

Country	Name	City	State
Denmark	University of Copenhagen, Centre of Integrated Rehabilitation of Cancer Patients	Copenhagen

Sponsors (5)

Lead Sponsor	Collaborator
University of Copenhagen	Beckett Foundation, Danish Cancer Society, Novo Nordisk A/S, TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Bone Mineral Density		Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Glucose tolerance	Oral Glucose Tolerance Test	Change from baseline to post intervention (12 weeks) and follow-up (32 weeks)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No