ClinicalTrials.Veeva

Menu

Elimination of Prostate Cancer Treatment Side Effects Using a Nutraceutical

O

Optimal Health Research

Status and phase

Suspended
Phase 2
Phase 1

Conditions

Prostate Cancer

Treatments

Dietary Supplement: N-111
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06643494
RLP051624.

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

Male

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Everyone else

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Triple Blind

100 participants in 3 patient groups, including a placebo group

N-111
Active Comparator group
Description:
Nutraceutical N-111 in conjunction with ADT + EBR will be given in this arm, once per day with breakfast.
Treatment:
Dietary Supplement: N-111
Placebo
Placebo Comparator group
Description:
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.
Treatment:
Other: Placebo
Control
No Intervention group
Description:
The control group will proceed with the ADT + EBR treatment without taking the active compactor or the placebo.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems