NCT00910884

Brief Summary

RATIONALE: Plant extracted natural compounds, in an adjunct therapy position, slow the growth and reproduction of Stage IV Breast Cancer tumor cells. May help eradicate different types of cancers. PURPOSE: The purpose of this randomized Phase I trial is to first IDENTIFY, through laboratory analysis and validating cellular biochemical pathways, and HELP CONTROL, using natural plant extracted compounds, G.R.A.S. (Generally Accepted As Safe), compounds, the reproduction, growth progress and metastasis of Stage IV Breast Cancer cells. The therapy position is adjunct to conventional therapies and in "one-off" trials have been excitingly effective for long-term survival. Novel use of bioactive GRAS compounds to augment and enhance conventional cancer therapies and as stand-alone parallel therapies.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
11.3 years until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

May 29, 2009

Last Update Submit

January 14, 2020

Conditions

Breast Cancer

Keywords

stage I breast cancerstage II breast cancerstage III breast cancerstage IV breast cancerhormonal cancersskin cancers

Outcome Measures

Primary Outcomes (4)

  • Utilize GRAS plant extracted compounds for suppression of cancer-cell replication.

    Using adjunct therapy to augment and increase efficacy of conventional cancer treatments

    12 months

  • Suppression of cancer genetic pathways to reproduction.

    suppress cancer cell proliferation

    6 months

  • Reduction of secondary bonding of TMPRSS2-ERG fusing using, among other modes of action, DPPH radical-scavenging activity

    Monitor levels

    6 months

  • Monitor normal metabolic function while measuring cancer-marker levels.

    metabolic function testing

    6 months

Study Arms (2)

Arm I

Patients receive oral GRAS supplements daily for 12 months or as possible within the patient's parameters.

Other: laboratory biomarker analysisProcedure: therapeutic dietary intervention

Arm II

Patients do not receive supplements.

Other: laboratory biomarker analysis

Interventions

laboratory biomarker analysisOTHER

No supplements are given

Arm IArm II
therapeutic dietary interventionPROCEDURE

Given orally daily for 12 months

Arm I

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale in breast cancer, any Stage.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Breast cancer not limited to "in-remission only." Any Stage of cancer; preference in population to Stage IV. Inclusions: Breast Cancer, any stage. In remission or not. Uterine Cancer, any stage. In remission or not. Ovarian Cancer, any stage. In remission or not. Hormonal Cancers, cell division driven by hormones. In remission or not. Skin Cancers, any stage. In remission or not. Exclusions: None noted at this time. Exclusions may be modified upon presentation. Look for updates.

DISEASE CHARACTERISTICS: * Diagnosis of prostate, breast, or uterine cancer * Early or late stage disease * Currently waiting to initiate conventional therapy or radiotherapy OR receiving concurrent conventional chemotherapy or radiation therapy * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior or concurrent chemotherapy or hormonal therapy for cancer allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Brabant Research, Incorporated

Spokane Valley, Washington, 99216, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsSkin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Richard E. Lasker, PhD

    Brabant Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 29, 2009

First Posted

June 1, 2009

Study Start

September 1, 2020

Primary Completion

March 1, 2021

Study Completion

September 1, 2021

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

US(1)