Elimination of Prostate Cancer Treatment Side Effects Using a Nutraceutical

NCT06643494 | Suspended Phase 1 DMC

• 1 other identifier: RLP051624.
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Self-reporting

  Self-reporting symptom severity and number of symptoms. The scoring is from 1 (no issue) to 10 (severe), across 14 questions.

  Weekly for the duration of EBR (6 weeks). Monthly for the duration of ADT (2 years).

Study Arms (3)

N-111

ACTIVE COMPARATOR

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

Dietary Supplement: N-111

Placebo

PLACEBO COMPARATOR

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

Control

NO INTERVENTION

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

Interventions

N-111 DIETARY_SUPPLEMENT

A combination of Acetogenins

N-111

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male undergoing treatment for prostate cancer with ADT + EBR.

You may not qualify if:

• Everyone else

Sponsors & Collaborators

• Optimal Health Research: lead

Study Sites (1)

Optimal Health Research

Salt Lake City, Utah, 84117, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Alan Jeppsen, MD

  Optimal Health Research

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Both the active compactor and the placebo will be in unlabeled foil packets. The contents will be the same weight and color.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 16, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)