Not provided
Not provided
Not provided
Not provided
Not provided
PPI currently unable to continue.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Does nutraceutical N-111 lower the number of side effects occurring during ADT + External Beam Radiation (EBR) prostate cancer treatment?
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-111 | Active Comparator | Nutraceutical N-111 in conjunction with ADT + EBR will be given in this arm, once per day with breakfast. |
|
| 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. |
|
| Control | No Intervention | The control group will proceed with the ADT + EBR treatment without taking the active compactor or the placebo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-111 | Dietary Supplement | A combination of Acetogenins |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reporting | 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). |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Male
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alan Jeppsen, MD | Optimal Health Research | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optimal Health Research | Salt Lake City | Utah | 84117 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
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.
Not provided
Not provided
Both the active compactor and the placebo will be in unlabeled foil packets. The contents will be the same weight and color.
| Other |
Placebo |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |