Elimination of Prostate Cancer Treatment Side Effects Using a Nutraceutical

March 6, 2025 updated by: Optimal Health Research

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

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

Study Overview

Status

Suspended

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • Optimal Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Everyone else

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: N-111
Nutraceutical N-111 in conjunction with ADT + EBR will be given in this arm, once per day with breakfast.
Dietary supplement: N-111
A combination of Acetogenins
Placebo Comparator: Placebo
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
Placebo
No Intervention: Control
The control group will proceed with the ADT + EBR treatment without taking the active compactor or the placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reporting
Time Frame: Weekly for the duration of EBR (6 weeks). Monthly for the duration of ADT (2 years).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Optimal Health Research

Investigators

  • Study Chair: Alan Jeppsen, MD, Optimal Health Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2024

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

October 10, 2024

First Submitted That Met QC Criteria

October 12, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RLP051624.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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