NCT06643494

Elimination of Prostate Cancer Treatment Side Effects Using a Nutraceutical

Alleviating Androgen Deprivation Therapy (ADT) + External Beam Radiation (EBR) Treatment Side Effects in Prostate Cancer Patients

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Optimal Health Research · Academic / Other
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	N-111	A combination of Acetogenins
OTHER	Placebo	Placebo

Timeline

• Start date: 2024-08-15
• Primary completion: 2026-09-15
• Completion: 2026-12-15
• First posted: 2024-10-16
• Last updated: 2025-03-11

Locations

1 site across 1 country: United States