Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-31 @ 2:38 PM
Study NCT ID:
NCT06643494
Status:
SUSPENDED
Last Update Posted:
2025-03-11
First Post:
2024-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elimination of Prostate Cancer Treatment Side Effects Using a Nutraceutical
Sponsor:
Optimal Health Research
Organization:
Study Overview
Official Title:
Alleviating Androgen Deprivation Therapy (ADT) + External Beam Radiation (EBR) Treatment Side Effects in Prostate Cancer Patients
Status:
SUSPENDED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PPI currently unable to continue.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: