Diet Effect on Cancer Treatment Outcome

Phase 1

Completed

• Conditions: Cancer Prostate; Cancer Breast
• Interventions: Other: Placebo

• Registration Number: NCT05410002
• Lead Sponsor: Optimal Health Research

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2022-06-04
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-08
• Study Start: 2022-10-12
• Primary Completion: 2024-04-01
• Status Verified: 2024-10
• Study Completion: 2024-10-01
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vegetarian placebo group	Placebo	The group will use a vegetarian diet with a placebo.
Non-vegetarian placebo control group	Placebo	The group will use a non-vegetarian diet with a placebo.

Primary Outcome Measures

Name	Time	Method
Active Comparator: Non-vegetarian N-111 group.	End of month 3.	Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.
Active Comparator: Vegetarian N-111 group	End of month 3.	Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.

Secondary Outcome Measures

Name	Time	Method
Placebo Comparator: Vegetarian placebo group	End of month 3.	Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.
Placebo Comparator: Non-vegetarian placebo control group	End of month 3.	Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.

Trial Locations

Locations (3)

KLE Academy of Higher Education & Research; 🇮🇳 Belagave, Karnataka, India

Indian Institute of Research; 🇮🇳 Mumbai, India

Optimal Health Research; 🇺🇸 Salt Lake City, Utah, United States