Diet Effect on Cancer Treatment Outcome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-12

Study Completion Date

2024-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Soy Compounds on Breast Cancer, Prostate Cancer, and Bone Health

NCT00200824

Breast Cancer Prostate Cancer

COMPLETED PHASE2

Feasibility of a Whole-Food, Plant-Based Diet for Patients With Low-Risk Chronic Lymphocytic Leukemia (CLL)

NCT06377501

Chronic Lymphocytic Leukemia Stage A(0)

COMPLETED NA

Role of Soy Supplementation in Prostate Cancer Development

NCT00255125

Prostate Neoplasm

COMPLETED PHASE3

Soy Bread Diet in Improving Immune Function in Participants With Prostate Cancer

NCT03654638

Prostate Adenocarcinoma

COMPLETED PHASE2

Dietary Soy Isoflavones for the Prevention of Cancer

NCT00003100

Unspecified Adult Solid Tumor, Protocol Specific

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Breast Cancer Prostate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized interventional parallel study

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Active product (N-111) and placebo will be in identical packets with the contents of identical weight, color and texture.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vegetarian N-111 group

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

Group Type ACTIVE_COMPARATOR

Dietary Supplement: N-111

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement N-111

Non-vegetarian N-111 group.

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

Group Type ACTIVE_COMPARATOR

Dietary Supplement: N-111

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement N-111

Vegetarian placebo group

The group will use a vegetarian diet with a placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Dietary placebo

Non-vegetarian placebo control group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Dietary placebo

Vegetarian control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Non-vegetarian control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dietary Supplement: N-111

Dietary supplement N-111

Intervention Type DIETARY_SUPPLEMENT

Placebo

Dietary placebo

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.