Prostate CancerPhase 1/2NCT06643494
Elimination of Prostate Cancer Treatment Side Effects Using a Nutraceutical
A Phase 1/2 study testing N-111 in people with Prostate Cancer, run by Optimal Health Research at 1 site in United States.
Trial summary
Does nutraceutical N-111 lower the number of side effects occurring during ADT + External Beam Radiation (EBR) prostate cancer treatment? Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- N-111
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2024to 15 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male undergoing treatment for prostate cancer with ADT + EBR.
Who cannot join
- Everyone else
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read the 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
- Being tested
- N-111, Placebo
- Keywords
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-111Dietary supplement
A combination of Acetogenins
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| N-111 | Active comparator | Nutraceutical N-111 in conjunction with ADT + EBR will be given in this arm, once per day with breakfast. Receives: 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. Receives: Other: Placebo |
| Control | No intervention | The control group will proceed with the ADT + EBR treatment without taking the active compactor or the placebo. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reporting
Self-reporting symptom severity and number of symptoms. The scoring is from 1 (no issue) to 10 (severe), across 14 questions.
Measured: Weekly for the duration of EBR (6 weeks). Monthly for the duration of ADT (2 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start15 Aug 2024
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Why it stopped: PPI currently unable to continue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Optimal Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan Jeppsen, MD, Study chair, Optimal Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643494
- Sponsor's protocol ID
- RLP051624.
- Status last verified
- Mar 2025
- First submitted
- 10 Oct 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alleviating Androgen Deprivation Therapy (ADT) + External Beam Radiation (EBR) Treatment Side Effects in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT06643494
- Acronym / sponsor ID
- RLP051624.
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: PPI currently unable to continue.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Optimal Health ResearchUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| N-111 | Active comparator | Dietary Supplement: N-111Nutraceutical N-111 in conjunction with ADT + EBR will be given in this arm, once per day with breakfast. |
| Placebo | Placebo comparator | Other: PlaceboA 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. |
| Control | No intervention | –The control group will proceed with the ADT + EBR treatment without taking the active compactor or the placebo. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male undergoing treatment for prostate cancer with ADT + EBR.
Key exclusion criteria (1 listed)
- Everyone else
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-111A combination of Acetogenins | Dietary supplement | N-111 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Jeppsen, MD study chair
Optimal Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing N-111 in people with Prostate Cancer, run by Optimal Health Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reporting (time frame: Weekly for the duration of EBR (6 weeks). Monthly for the duration of ADT (2 years).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.