A Phase 1/2 interventional study of N-111 and Placebo in Prostate Cancer, sponsored by Optimal Health Research. Suspended at 1 site in United States. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by Optimal Health Research · Phase 1/2, Interventional, and Supportive care
Does nutraceutical N-111 lower the number of side effects occurring during ADT + External Beam Radiation (EBR) prostate cancer treatment?
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 100 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Optimal Health Research is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nutraceutical N-111 in conjunction with ADT + EBR will be given in this arm, once per day with breakfast.
Dietary Supplement: N-111
A placebo that is inert but appears to look the same as the active comparator in conjunction with ADT + EBR, given once per day with breakfast.
Other: Placebo
The control group will proceed with the ADT + EBR treatment without taking the active compactor or the placebo.
A combination of Acetogenins
Placebo
Self-reporting
Self-reporting symptom severity and number of symptoms. The scoring is from 1 (no issue) to 10 (severe), across 14 questions.
Time frame: Weekly for the duration of EBR (6 weeks). Monthly for the duration of ADT (2 years).
Plan to share: No
No publications or documents are linked to this record.
This study is suspended, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Optimal Health Research