NCT02286778

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_2 breast-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2014

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

November 3, 2014

Last Update Submit

August 2, 2017

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of participants tumor free

    assessed by MRI

    12 months

Study Arms (3)

Acetogenins

ACTIVE COMPARATOR

Dietary Supplement: Acetogenins BID for 12 months

Dietary Supplement: Acetogenins

Placebo

PLACEBO COMPARATOR

Dietary Supplement: No Acetogenins BID for 12 months

Dietary Supplement: Placebo

Control

NO INTERVENTION

Control subjects will not receive the Acetogenins or the placebo. They will be evaluated every other month to monitor disease progress.

Interventions

AcetogeninsDIETARY_SUPPLEMENT

Acetogenins BID for 12 months

Acetogenins
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age35 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Acetogenins

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fatty AlcoholsAlcoholsOrganic ChemicalsAlkanesHydrocarbons, AcyclicHydrocarbonsPolyketidesLactonesFuransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMacrocyclic CompoundsPolycyclic CompoundsLipids

Study Officials

  • John A Shaw, MD

    Optimal Health Research

    PRINCIPAL INVESTIGATOR

  • Steven Osguthorpe, ND

    Optimal Health Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2014

First Posted

November 10, 2014

Study Start

February 1, 2016

Primary Completion

January 1, 2017

Study Completion

August 1, 2017

Last Updated

August 3, 2017

Record last verified: 2017-08