Prostate Cancer
Conditions
Keywords
Prostate Cancer
Brief summary
Does nutraceutical N-111 lower the number of side effects occurring during ADT + External Beam Radiation (EBR) prostate cancer treatment?
Detailed description
Researchers will compare nutraceutical N-111 to a placebo (a look-alike substance that contains no active ingredients) and control group to see if N-111 works to alleviate side effects of prostate cancer treatment. Participants will: Take N-111 or a placebo by mouth every day for the duration of the ADT + EBR therapy. Fill out the self-evaluation reporting form weekly during EBR therapy and every three months during ADT therapy to assess their symptoms or lack of symptoms. The patients will see a physician once a week during the EBR therapy and once every three months for the duration of the ADT therapy.
Interventions
DIETARY_SUPPLEMENTN-111
A combination of Acetogenins
OTHERPlacebo
Placebo
Sponsors
Optimal Health Research
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Both the active compactor and the placebo will be in unlabeled foil packets. The contents will be the same weight and color.
Intervention model description
The study consists of a single group of subjects included in the study design, in which all subjects receive a single intervention, N-111, and the outcomes are assessed over time.
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male undergoing treatment for prostate cancer with ADT + EBR.
Exclusion criteria
* Everyone else
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reporting | Weekly for the duration of EBR (6 weeks). Monthly for the duration of ADT (2 years). | Self-reporting symptom severity and number of symptoms. The scoring is from 1 (no issue) to 10 (severe), across 14 questions. |
Countries
United States
Outcome results
None listed