Elimination of Prostate Cancer Treatment Side Effects Using a Nutraceutical

NCT ID: NCT06643494

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-15

Study Completion Date

2026-12-15

Brief Summary

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

Detailed Description

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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

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Both the active compactor and the placebo will be in unlabeled foil packets. The contents will be the same weight and color.

Study Groups

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N-111

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

Group Type ACTIVE_COMPARATOR

N-111

Intervention Type DIETARY_SUPPLEMENT

A combination of Acetogenins

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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N-111

A combination of Acetogenins

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Everyone else
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Optimal Health Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alan Jeppsen, MD

Role: STUDY_CHAIR

Optimal Health Research

Locations

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Optimal Health Research

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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RLP051624.

Identifier Type: -

Identifier Source: org_study_id

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