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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50739

Enrollment

208

Registered

2017-04-03

Start date

2017-09-08

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Participants will be randomly assigned to one of the two intervention groups. The control group will be recruited separately. Both intervention groups receive high-intensity resistance exercise trai

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
The primary study endpoint will be quadriceps cross sectional area (measured by CT) and muscle strength. Measurements of cross sectional area and muscle strength will be performed at baseline and after 5 and 12 months	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)