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Natural Supplements Special Diet: Eliminating Cancer-impacting Hormones From Sources Outside the Body in Patients With Early-Stage or Remission Breast Cancer.

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified July 2017 by Dr. Richard Lasker, Brabant Research
Sponsor:
Information provided by (Responsible Party):
Dr. Richard Lasker, Brabant Research
ClinicalTrials.gov Identifier:
NCT00910884
First received: May 29, 2009
Last updated: July 18, 2017
Last verified: July 2017
  Purpose

RATIONALE: Natural supplements and a special diet may help rid the body of estrogen and testosterone and may slow the growth of tumor cells.

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 supplements and a special diet work, extemporaneous and environmental (man-made) hormones, hormone impacting compounds and hormone-mimicking compounds that are made outside the body, found in manufactured products or in-taken to the body of cancer patients through life-style, environmental or consumption products. Patients with early-stage or remission stage prostate cancer, breast cancer, or uterine cancer have a much greater sensitivity to these extemporaneous hormonal or hormonal influencing compounds.


Condition Intervention
Breast Cancer Other: laboratory biomarker analysis Procedure: therapeutic dietary intervention

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Gene Expression Control Using Micro-Trace Element Compounds During C.A.M., Adjunct Therapy and Conventional Cancer Protocols

Resource links provided by NLM:


Further study details as provided by Dr. Richard Lasker, Brabant Research:

Primary Outcome Measures:
  • Sequestration and elimination of exogenous estrogens from the body using multiple naturally-occurring micro-trace element compounds [ Time Frame: 6 months ]
    lowering body estrogens as related to hormone driven cancer

  • Suppression of proliferation-stimulating activities using naturally-occurring flavonoids [ Time Frame: 6 months ]
    suppress cancer cell proliferation

  • Reduction of secondary bonding of TMPRSS2-ERG fusing and negative-bonded environmental estrogen using DPPH radical-scavenging activity [ Time Frame: 6 months ]
    Monitor levels

  • Maintenance of normal metabolic function using a full diet of specifically grown inclusion produce [ Time Frame: 6 months ]
    metabolic function testing


Estimated Enrollment: 300
Anticipated Study Start Date: August 2018
Estimated Study Completion Date: February 2020
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arm I
Patients receive oral natural supplements comprising indole-3-carbinol, perillyl alcohol, glucuronic acid, and flavonoids daily for 12 months. Patients also consume whole foods comprising indole-3-carbinol and a diet that eliminates exogenous growth hormones.
Other: laboratory biomarker analysis
No supplements are given
Procedure: therapeutic dietary intervention
Given orally daily for 12 months
Arm II
Patients do not receive natural supplements or consume whole foods or a special diet.
Other: laboratory biomarker analysis
No supplements are given

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female in breast cancer remission, any Stage.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Breast cancer limited to "in-remission only." Any Stage of cancer; wholly limited to "in remission."
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of prostate, breast, or uterine cancer

    • Early-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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910884

Locations
United States, Washington
Brabant Research, Incorporated Not yet recruiting
Spokane Valley, Washington, United States, 99216
Contact: Richard E. Lasker, PhD    509-340-9902    rel@brabantresearch.com   
Sponsors and Collaborators
Brabant Research
Investigators
Principal Investigator: Richard E. Lasker, PhD Brabant Research
  More Information

Responsible Party: Dr. Richard Lasker, Director, Brabant Research
ClinicalTrials.gov Identifier: NCT00910884     History of Changes
Other Study ID Numbers: CDR0000643461
BRABANT-00005271
Study First Received: May 29, 2009
Last Updated: July 18, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Richard Lasker, Brabant Research:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 23, 2017