Nutraceutical for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a supplement called N-111, a nutraceutical, can reduce side effects for men receiving prostate cancer treatment. Participants will receive either N-111 with their usual therapy, a placebo, or just the standard treatment. The goal is to determine if N-111 eases the experience of hormone and radiation therapy. Men currently undergoing both hormone treatment and radiation for prostate cancer might be suitable candidates. As a Phase 1 and Phase 2 trial, this research aims to understand how N-111 works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage research.
Do I need to stop taking my current medications for this trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that N-111 is likely to be safe for humans?
A previous study did not provide specific safety data for the nutraceutical N-111. However, as the trial is in the early stages (Phase 1 and Phase 2), N-111 is under careful observation for safety in humans. Early-phase trials typically assess how well participants tolerate a treatment and identify any side effects.
Reaching these phases often indicates that initial tests have not revealed major safety concerns, though this is not guaranteed. Participants should report any side effects they experience to help researchers better understand the treatment's safety.
Prospective participants should discuss any concerns with their doctor, who can provide personalized advice.12345Why do researchers think this study treatment might be promising?
Unlike the standard of care for prostate cancer, which typically involves androgen deprivation therapy (ADT) and external beam radiation (EBR), N-111 is a nutraceutical that is taken daily with breakfast. Researchers are excited about N-111 because it incorporates natural compounds that might enhance the effectiveness of traditional treatments. This treatment stands out by potentially offering a gentler approach with fewer side effects compared to conventional medications. Additionally, its unique combination with ADT and EBR could improve outcomes by targeting cancer cells through multiple pathways.
What evidence suggests that N-111 might be an effective treatment for prostate cancer?
Research has shown that the supplement N-111, which participants in this trial may receive, might help reduce side effects during prostate cancer treatment. Although direct studies on N-111 are limited, it appears to work in a potentially beneficial way. In this trial, N-111 aims to help the body cope with challenging treatments like hormone therapy (ADT) and radiation (EBR). Early indications suggest it might make these treatments more comfortable, but more information is needed. The goal is to improve comfort during these intense therapies by reducing side effects.678910
Who Is on the Research Team?
Alan Jeppsen, MD
Principal Investigator
Optimal Health Research
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment - EBR
Participants receive External Beam Radiation (EBR) therapy and take N-111 or placebo daily
Treatment - ADT
Participants continue Androgen Deprivation Therapy (ADT) and take N-111 or placebo daily
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- N-111
Find a Clinic Near You
Who Is Running the Clinical Trial?
Optimal Health Research
Lead Sponsor