Trial document




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  DRKS00009975

Trial Description

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Title

Influences of targeted exercise therapy on treatment-related side effects of hormonetherapy in prostate cancer patients

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Trial Acronym

Burgdorf-Study

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URL of the Trial

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Brief Summary in Lay Language

The side effects of androgen deprivation therapy in prostate cancer patients is well known. Several studies suggest that physical activity has the potential to reduce side effects and therefore improve the quality of life of these patients.
The aim of this study is to investigate if the targeted exersice training affects the strength of patients with prostate cancer receiving hormon therapy. The patients take either part in an low endurance training or an intensive resistance and endurance training throughout one year.
Further endpoints of this study are quality of life, fatigue, body composition etc.
The measurments are performed at baseline and after 3,6,9 and 12 months and after 6 and 12 months follow-up.

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Brief Summary in Scientific Language

The Burgdorf-Study is a prospective, single-center, randomized, controlled trial which examines the influence of an intensive resistancen and endurance training compared to a low intensiv endurance training on the side effects of andorgen-deprivation therapy in prostate cancer patients. The duration of the intervention is one year with a follow-up periode of one year. The primary endpoint is the strength of the lower extremities. Secondary endpoints include quality of life, fatigue, endurence, erectile dysfunction, bone pain, activity level, body composition, bine mineral density, PSA and testosterone levels. In order to observe the sustainability of the intervention, 2 follow-up measurements are planned (6 and 12 months after the intervention).

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Organizational Data

  •   DRKS00009975
  •   2016/02/09
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  •   yes
  •   Approved
  •   144/2015, Köln - Ethikkomisscion der Deutschen Sporthochschule zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Strength-endurance training: 2x per week supervised about 75min, warming-up, 7 different strength exercises (2-4 series á 8-12 repetitions at 75 % of 1RM) + impact-training, cooling-down
  •   Endurance: 1x per week supervised, 1x per week home-based walking program, 30-45 minutes (at 50-60 % of max heart rate)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Strength: dynamically on a isokinetic dynamometer

Measurements: Baseline, 3, 6 and 12 months, and 6 and 12 months follow-up

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Secondary Outcome

Endurance with a 30/15 Test on a bicycle ergometer
Quality of life via a questionnaire (EORTC QLQ - C30 and PR25)
Fatigue via a questionnaire (MFI)
Body composition via BIA (bioelectrical impedance analysis)
erectile dysfunction via a questionnaire (IIEF)
bone pain via a questionnaire (FACT- BP)
Activity level via questionnaires (QPAQ and KAS )
BMI
BMD via DXA scan
PSA and testosterone value

Measurement timing: See primary endpoint, except bone density
BMD measurements: baseline, after 12 months and 12 months follow -up

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Doctor's Practice 
  • other 
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Recruitment

  •   Planned
  •   2016/02/10
  •   60
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Prostate cancer patients who have received hormone therapy continuously at least over a period of 3 months and a maximum of 12 months. The treatment needs to be continue for at least one year. Half of the patients ( n = 30) received Leuprone® , the other half ( n = 30) alternative hormonal therapies.

Serum testosterone levels < 0,50ng / ml (range castration)

Age > 18

singed informed consent

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Exclusion Criteria

ongoing medication with tricyclic antidepressants and duloxetine (Yentreve)

WHO / ECOG performance status> 2

Planned OP

Life expectancy <6 months

All disease situations that do not allow a sporting activity, in particular:
Clinically manifest heart failure (NYHA III-IV)
Respiratory partial or global failure
Durable thrombocytopenia <10,000 / ul, for example, Autoimmunthrombozytopenien intractable.
Congenital or acquired thrombocytopenia or any coagulation disorder.
Symptomatic CHD (possibly performing exercise ECG is recommended)
Severe intractable hypertension
Not adjustable COPD
Uncontrolled cerebral convulsions
CNS metastases
Medical or mental state that leads the investigator to not allowing the patient to participate in the study. or a legally binding signature of the consent form does

Unwillingness to storage and transfer of personal data in the context of the study protocol.

Participation in another sport-study

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Addresses

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    • Deutsche Sporthochschule zu Köln
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Urologie des MVZ Burgdorf
    • Mr.  Dr.  Robert  Hafke 
    • Norderneystr. 1
    • 31303  Burgdorf
    • Germany
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    • Weststadt Reha
    • Mr.  Mike  Wrensch 
    • Norderneystr. 1
    • 31303  Burgdorf
    • Germany
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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin
    • Mr.  PD  Freerk  Baumann 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Deutsche Sporthochschule Köln, Institut für Kreislaufforschung und Sportmedizin
    • Ms.  Anja  Großek 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Sandoz International GmbH
    • Industriestr. 25
    • 83607  Holzkirchen
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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