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Trial Title:
Elimination of Prostate Cancer Treatment Side Effects Using a Nutraceutical
NCT ID:
NCT06643494
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate Cancer
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Intervention 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.
Primary purpose:
Supportive Care
Masking:
Triple (Participant, Care Provider, Investigator)
Masking description:
Both the active compactor and the placebo will be in unlabeled foil packets. The contents
will be the same weight and color.
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
N-111
Description:
A combination of Acetogenins
Arm group label:
N-111
Intervention type:
Other
Intervention name:
Placebo
Description:
Placebo
Arm group label:
Placebo
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male undergoing treatment for prostate cancer with ADT + EBR.
Exclusion Criteria:
- Everyone else
Gender:
Male
Gender based:
Yes
Gender description:
Male
Minimum age:
40 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Optimal Health Research
Address:
City:
Salt Lake City
Zip:
84117
Country:
United States
Start date:
August 15, 2024
Completion date:
December 15, 2026
Lead sponsor:
Agency:
Optimal Health Research
Agency class:
Other
Source:
Optimal Health Research
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06643494
