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Completed

NCT Number: NCT05410002

Diet Effect on Cancer Treatment Outcome

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

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Key information

Conditions

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

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

KLE Academy of Higher Education & Research, Belagāve, Karnataka, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary Supplement: N-111

Dietary Supplement

Dietary supplement N-111

Placebo

Other

Dietary placebo

Primary outcomes

  1. Active Comparator: Vegetarian N-111 group

    Time frame: End of month 3.

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

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

    Time frame: End of month 3.

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

Secondary outcomes

  1. Placebo Comparator: Vegetarian placebo group

    Time frame: End of month 3.

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

  2. Placebo Comparator: Non-vegetarian placebo control group

    Time frame: End of month 3.

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

Sponsors and collaborators

Lead sponsor

Optimal Health Research

Other

Registry information

Official study title

A Study on the Effect Diet Has Affecting the Response of Patients Taking N-111 Who Are on a Vegetarian Diet Vs a Non-vegetarian Diet or a Placebo

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 8, 2022
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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