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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01711892
Other study ID # CIRE-04
Secondary ID
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


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
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