Elimination of Prostate Cancer Treatment Side Effects Using a Nutraceutical

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

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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.