Resistance exercise training and protein supplementation to prevent side effects of androgen deprivation therapy (ADT) in men with prostate cancer

Completed

Conditions: spiermassaverlies door androgeen deprivatie therapie bij prostaatakanker
loss of muscle mass and prostate cancer
10038597

Registration Number: NL-OMON50739

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 208

Inclusion Criteria

- Men with proven PC (starting) with ADT which will be continued for at least
6 months

Exclusion Criteria

- Patients who are not able to perform basic activities of daily living such as
walking or patients who are suffering from other disabling comorbidity that
seriously hamper physical exercise (e.g. heart failure, chronic obstructive
pulmonary disease (COPD), orthopedic conditions and neurological disorders).
- Patients with allergies to whey protein or lactose intolerance
- Patients who show cognitive disorders or severe emotional instability
- Unable to speak, understand and read the Dutch language
- Estimated life expectancy < 1 year

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study endpoint will be quadriceps cross sectional area (measured by<br /><br>CT) and muscle strength.<br /><br>Measurements of cross sectional area and muscle strength will be performed at<br /><br>baseline and after 5 and 12 months</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoints will be body composition (body mass index, waist<br /><br>circumference, muscle mass, fat mass, body fat distribution), measured by<br /><br>anthropometrics and DEXA, physical performance, endurance capacity, level of<br /><br>physical activity, level of independent living, nutritional intake, HRQoL,<br /><br>fatigue, comorbidity, blood results, muscle characteristics, and compliance.<br /><br>Measurements of body composition and physical performance will be performed at<br /><br>baseline and after 5 and 12 months. Questionnaires on level of physical<br /><br>activity and independent living, fatigue, HRQoL and comorbidity will be taken<br /><br>at baseline, 5, 12 and 24 months.<br /><br>Blood samples will be taken at 0, 5 and 12 months. Endurance capacity<br /><br>(spiroergometry) and muscle characteristics (biopsies) will be measured at 0<br /><br>and 5 months.</p><br>