Diet Effect on Cancer Treatment Outcome

NCT05410002 | Completed Phase 1 DMC

• 1 other identifier: N-111012422
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 3

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.

Conditions

Cancer Breast; Cancer Prostate

Keywords

Cancer

Outcome Measures

Primary Outcomes (2)

• Active Comparator: Vegetarian N-111 group

  Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.

  End of month 3.

• Active Comparator: Non-vegetarian N-111 group.

  Change in blood levels (CA, CMP, CBC, CEA, Lipids, CRP) from base line to the end of month 3.

  End of month 3.

Secondary Outcomes (2)

• Placebo Comparator: Vegetarian placebo group

  End of month 3.

• Placebo Comparator: Non-vegetarian placebo control group

  End of month 3.

Study Arms (6)

Vegetarian N-111 group

ACTIVE COMPARATOR

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

Dietary Supplement: Dietary Supplement: N-111

Non-vegetarian N-111 group.

ACTIVE COMPARATOR

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

Dietary Supplement: Dietary Supplement: N-111

Vegetarian placebo group

PLACEBO COMPARATOR

The group will use a vegetarian diet with a placebo.

Other: Placebo

Non-vegetarian placebo control group

PLACEBO COMPARATOR

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

Other: Placebo

Vegetarian control group

NO INTERVENTION

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

Non-vegetarian control group

NO INTERVENTION

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

Interventions

Dietary Supplement: N-111 DIETARY_SUPPLEMENT

Dietary supplement N-111

Non-vegetarian N-111 group.; Vegetarian N-111 group

Placebo OTHER

Dietary placebo

Non-vegetarian placebo control group; Vegetarian placebo group

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Optimal Health Research: lead

Study Sites (3)

Optimal Health Research

Salt Lake City, Utah, 84117, United States

Location

KLE Academy of Higher Education & Research

Belagāve, Karnataka, 590010, India

Location

Indian Institute of Research

Mumbai, 400028, India

Location

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• EA Jeppsen, MD

  Optimal Health Research

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Active product (N-111) and placebo will be in identical packets with the contents of identical weight, color and texture.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized interventional parallel study

Study Record Dates

• First Submitted: June 4, 2022
• First Posted: June 8, 2022
• Study Start: October 12, 2022
• Primary Completion: April 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2); US (1)