This trial is examining the effectiveness of diet and exercise during ADT treatment for men with prostate cancer. The main outcome to be measured will be the change in body mass index (BMI, a measure of body fat that takes height and weight into account). This study is being conducted in Los Angeles and Kansas City, Kansas, in the United States.
The details
Prostate cancer is a very treatable cancer but those treatments can have long-lasting effects. A kind of hormone therapy called Androgen Deprivation Therapy (ADT) is often used along with other treatments like radiation and has been shown to improve survival. However, ADT can have negative effects especially on the heart and metabolism (the body's system for using and storing energy).
This study is examining the effect that diet, exercise and counselling has on men who are undergoing ADT. Outcomes will be measured as the change in body mass index and blood cholesterol and glucose levels.
Who are they looking for?
This study is recruiting 150 men undergoing ADT. Patients must able to speak and read in English or Spanish, be reachable consistently by telephone, and must be able to travel to a study center.
How will it work
Participants will be randomly assigned into two different groups. One group will take part in a 6-month exercise program and diet and nutrition coaching program. This program will be carried out in person, and also through phone calls and smartphone use. Participants will also receive the usual care they would normally receive if not taking part in this study. The other group will receive the level of care patients normally get while undergoing ADT treatment (referral to information website). All patients will have blood drawn and be asked questions about how they are feeling during their participation.
Participation in this study will last for up to 12 months.
