Prostate Cancer Clinical Trial
Official title:
Exercise Intervention to Reduce Adverse Quality of Life Effects From Androgen Deprivation Therapy for Prostate Cancer - Randomized Clinical Trial
This study evaluates effects of supervised exercise in reducing adverse effects of hormonal treatment, increasing quality of life and in inducing a long-term change into more active lifestyle in prostate cancer patients on androgen deprivation therapy. All participants will attend a starting lecture at the beginning of the trial, after which they are randomly allocated to attend 3 months of either supervised or non-supervised exercise program. Leisure time activity, quality of life, blood sugar and cholesterol values, and body composition of participants will be evaluated at three time-points; at recruitment, after 12 weeks and after 24 weeks. Effects on quality of life will also be qualitatively evaluated with single- and group interviews.
Androgen deprivation therapy (ADT) is commonly used in management of advanced or recurrent
prostate cancer. It also frequently used adjuvant to curative-intent radiation therapy for
localized prostate cancer. Low testosterone levels during androgen deprivation commonly cause
adverse effects reducing quality of life. Most common adverse effects include fatigue, weight
gain, loss of lean muscle mass, hyperglycemia and hypercholesterolemia.
Regular exercise, especially programs involving combination of both aerobic exercise and
resistance training has been shown to reduce to reduce adverse effects of ADT on physical
functioning and quality of life. It may also improve disease prognosis.
The study compares effects of supervised and unsupervised exercise on plasma lipid parameters
(total cholesterol, LDL, HDL and triglycerides) and glucose levels (fasting plasma glucose,
glycated hemoglobin), overall quality of life and on average daily exercise activity in men
with prostate cancer and under ADT. As secondary outcome we will study effect on continued
exercise activity after the intervention, changes in body composition, blood pressure and
risk of fractures, castration resistance as well as death due to prostate cancer and due to
any cause.
Study hypothesis is that supervised exercise will improve quality of life, lipid and glucose
parameters and increase daily exercise activity more that non-supervised exercise. We also
expect higher continued exercise activity, greater changes in body composition and blood
pressure and lowered risk of fractures and death in the supervised exercise group.
This is a randomized, controlled clinical trial. The study aims to recruit 40 men on ADT for
prostate cancer. This will be a pilot study to estimate effect sizes in Finnish population to
inform further larger trial.
All participants attend introductory lecture, where a urologist informs them about adverse
effects of ADT and positive effects of exercise during ADT, exercise instructor gives advice
for training both at home and in the gym and nutritional therapeutist tells about nutrition
to overcome adverse effects of ADT and support training.
After the introductory lecture the participants are randomized 1:1 to either the supervised
or non-supervised exercise group (Figure). Men in the supervised group participate in
progressive group exercise sessions twice a week for total of 12 weeks at the Varala sports
academy in Tampere, Finland. Each exercise session includes both aerobic and resistance
training targeting all major muscle groups (Additional document I, exercise program). The
non-supervised group will exercise independently for 12 weeks according to the instructions
given at the introductory lecture. The first control visit will be after this first period of
12 weeks of exercise.
After the first follow-up visit both group will continue non-supervised exercise for 12
weeks, after which the second control visit will be arranged. Special focus on the second
control visit is to see how many in each group has been able to carry on active exercising,
i.e. has the intervention promoted long-term change in exercise activity.
Both study group will be given Polar wrist activity monitors to be used 24 h/day for the
entire course of the study.
All participants are asked to fill validated quality of life surveys EORTC QLQC-30 (overall
quality of life) and EORTC QLQC-PR25 (prostate cancer-specific quality of life) at baseline
and again at 1st and 2nd control visits. Additionally, qualitative evaluation of quality of
life as well as perceived possibilities and obstacles for exercise are evaluated in
individual- and group interviews during the study visits. Plasma lipid and glucose
parameters, blood pressure and body composition will be measured at each of these visits.
At each visit a separate blood sample is taken and stored for future measurement of
biomarkers associated with prostate cancer progression, glucose and lipid metabolism and
effects of exercise.
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