Eradication of Malignant Carcinoma in the Breast Tissue

August 2, 2017 updated by: Optimal Health Research

The Eradication of Malignant Carcinoma in the Breast Tissue Using an ATP (Adenosine-5'-Triphosphate) Inhibitor

The purpose of this study is to confirm the findings of an early study and expand our knowledge of treating Malignant Carcinoma in the Breast Tissue Using an ATP (Adenosine-5'-Triphosphate) Inhibitor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Clinical diagnosis of breast cancer
  • Referred to the study by their treating physician

Exclusion Criteria:

  • Any type of treatment for breast cancer before starting the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Acetogenins
Dietary Supplement: Acetogenins BID for 12 months
Dietary supplement: Acetogenins
Acetogenins BID for 12 months
PLACEBO_COMPARATOR: Placebo
Dietary Supplement: No Acetogenins BID for 12 months
Dietary supplement: Placebo
NO_INTERVENTION: Control
Control subjects will not receive the Acetogenins or the placebo. They will be evaluated every other month to monitor disease progress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants tumor free
Time Frame: 12 months
assessed by MRI
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Optimal Health Research

Investigators

  • Principal Investigator: John A Shaw, MD, Optimal Health Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

November 3, 2014

First Submitted That Met QC Criteria

November 7, 2014

First Posted (ESTIMATE)

November 10, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2017

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-9892131B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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