Nutraceutical for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: Optimal Health Research

Must be taking: ADT

Disqualifiers: Everyone else

Compensation: Varies

Number of Visits: 2

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Does nutraceutical N-111 lower the number of side effects occurring during ADT + External Beam Radiation (EBR) prostate cancer treatment?

Research Team

Alan Jeppsen, MD

Principal Investigator

Optimal Health Research

Eligibility Criteria

This trial is for men currently receiving ADT (Androgen Deprivation Therapy) and External Beam Radiation (EBR) for prostate cancer. It's not open to anyone else.

Inclusion Criteria

I am a man being treated for prostate cancer with hormone therapy and external beam radiation.

Exclusion Criteria

Everyone else

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - EBR

Participants receive External Beam Radiation (EBR) therapy and take N-111 or placebo daily

6 weeks

1 visit per week (in-person)

Treatment - ADT

Participants continue Androgen Deprivation Therapy (ADT) and take N-111 or placebo daily

2 years

1 visit every 3 months (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• N-111

Trial Overview The study is testing whether a nutraceutical called N-111 can reduce side effects in patients undergoing ADT + EBR treatment for prostate cancer, compared to a placebo.

Participant Groups

Group I: N-111 Active Control 1 Intervention

Nutraceutical N-111 in conjunction with ADT + EBR will be given in this arm, once per day with breakfast.

Group II: Control Active Control 1 Intervention

The control group will proceed with the ADT + EBR treatment without taking the active compactor or the placebo.

Group III: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Optimal Health Research

Lead Sponsor

Trials

9

Recruited

900+