Prostate cancer and diet - a randomized controlled trial on the effect of a dietary intervention on the quality of life of men and serum nutrient levels in their blood.
- Conditions
- dietary changes, active surveillance, prostate cancer
- Registration Number
- NL-OMON20602
- Lead Sponsor
- Department of Urology, Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 255
Inclusion Criteria
Men (aged > 18 years), diagnosed with low-risk prostate cancer defined as T1 or T2a, Gleason 2-6 and PSA level <10 ng/ml, who are currently on active surveillance. Participants must be able to understand and read Dutch. Furthermore they must be able to cook meals or have meals prepared for them.
Exclusion Criteria
Men diagnosed with low-risk prostate cancer and treated with radical prostatectomy or radiotherapy (i.e. another type of therapy than active surveillance. Men diagnosed with intermediate- or aggressive prostate cancer. Participants that cannot adhere to the prostate cancer diet. People who are vegetarian, are gluten- or lactose-intolerant, or follow any other kind of diet.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To improve participants' quality of life, as measured by the SF-12 general health domain, by actively engaging in a prostate cancer diet.
- Secondary Outcome Measures
Name Time Method (I) To improve participants' feeling of being in control of their disease, as measured with the Prostate Activation Measure (PAM), by actively engaging in a prostate cancer diet. (II) To measure the effect of a dietary intervention with special grown products on the serum nutrient concentrations of participants. (III) To survey the user behavior of both participants and their partners when engaging in a prostate cancer diet. (IV) To test the infrastructure of greenkeepers in the Westland, producing and delivering products for a specific, targeted patient population instead of the general public.