Diet Effect on Cancer Treatment Outcome

Optimal Health Research

Status and phase: Completed; Phase 1

Conditions: Cancer Prostate; Cancer Breast

Treatments: Dietary Supplement: Dietary Supplement: N-111; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05410002

N-111012422

Details and patient eligibility

About

The study will look at the end result of 2 types of diets effect on treatment outcome of cancer patients using N-111.

Full description

The study will be evaluated during a double blind, placebo-controlled evaluation of the effect diet has on the response of patients taking N-111 who are on a vegetarian diet vs a non-vegetarian diet or a placebo. This will involve assessing the patients progress or lack thereof over a 3-month period of time as outlined in Outcome Measures section below.

Enrollment: 160 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A positive diagnosis of breast cancer as determined by Fine Needle Biopsy or open biopsy with associated Cancer Antigen blood markers.
• Prostate cancer as determined by a Transrectal Biopsy with associated Prostate- specific antigen blood work.

Exclusion criteria

• •Patients without the positive diagnosis of breast or prostate cancer.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 6 patient groups, including a placebo group

Vegetarian N-111 group

Active Comparator group

Description:

The group will use a vegetarian diet with the active compactor N-111.

Treatment:

Dietary Supplement: Dietary Supplement: N-111

Non-vegetarian N-111 group.

Active Comparator group

Description:

The group will use a non-vegetarian diet with the active compactor N-111.

Treatment:

Dietary Supplement: Dietary Supplement: N-111

Vegetarian placebo group

Placebo Comparator group

Description:

The group will use a vegetarian diet with a placebo.

Treatment:

Other: Placebo

Non-vegetarian placebo control group

Placebo Comparator group

Description:

The group will use a non-vegetarian diet with a placebo.

Treatment:

Other: Placebo

Vegetarian control group

No Intervention group

Description:

The group will use a vegetarian diet without the active compactor N-111 or the placebo.

Non-vegetarian control group

No Intervention group

Description:

he group will use a non-vegetarian diet without the active compactor N-111 or the placebo.