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

Due to the increase of our aging population and the advances in prostate cancer
(PC) treatment, the prevalence of PC patients rises. One of the cornerstones in
PC treatment is the use of androgen deprivation therapy (ADT). Unfortunately,
ADT leads to unfavorable changes in body composition, decreased physical
performance, fatigue and a lower health related quality of life (HRQoL).
Exercise- and nutritional interventions have the potential to diminish the side
effects of ADT treatment. A substantial number of studies in patients with PC
undergoing ADT show positive effects of exercise training on these side
effects. Moreover, studies in elderly have shown that the addition of a protein
supplement can enhance the positive effects of exercise training on lean body
mass, muscle strength and physical performance compared to exercise alone.
However, the usual care of PC patients does not contain a combined exercise and
protein supplementation program yet.

To investigate if a combined intervention of resistance training and protein
supplementation is more effective to prevent or decrease the adverse effects of
ADT on body weight and body composition in men with PC compared to training
alone or usual care.

Randomized placebo controlled trial with three parallel groups.

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 training under direct personal
supervision (twice a week, for 60 min, during 20 weeks). After 20 weeks, the
patient will be encouraged to continue regular exercise at home or in the
neighbourhood. During the 20 weeks training program participants will receive a
placebo or protein supplement (35 gram protein) immediately after each exercise
session and every evening prior to sleep. Patients in the control group will
receive usual care.

In addition to the appointments for usual medical care, all patients will be
asked to spend half a day (morning or afternoon) at 0, 5 and 12 months for
measurements of body composition, physical performace, and questionaires. At 24
months all patients will be asked to spend 30 minutes on filling in
questionnaires. In addition patients will be asked to fill in a food diary (3
days) and to wear an accelerometer (7 days) in the week prior to the
measurements at 0, 5 and 12 months.
Risks as the result of participation in this study are minimal. There are no
complications associated with the procedure of a DEXA and CT scan. The level of
radiation emitted during DEXA and CT scanning is merely a fraction of that
emitted during a transcontinental flight. Muscle biopsies will be taken under
local anaesthesia by an experienced physician, but may cause some minor
discomfort for maximally up to 24 h after completion. The discomfort is
comparable to muscle soreness or the pain one has after bumping into a table.
In rare conditions, the biopsy can lead to local infection or bleeding.
Patients allocated to the intervention groups are supposed to participate in a
20*week exercise program, twice a week for 60 minutes. We expect that the
exercise program will have a beneficial effect on the patients* health status.
As a result of the resistance type exercise training program, participants will
likely experience a gain in muscle mass and strength and a healthy improvement
in body composition. Depending on the baseline level of fitness, this will
result in an increase in functional performance. It is possible that
participants may experience muscle soreness induced by unaccustomed exercise.
The ingested protein and placebo supplements are regular food substances and
therefore part of the normal diet.