Natural Supplements and a Special Diet in Eliminating Growth Hormones Made Outside the Body in Patients With Early-Stage Prostate Cancer, Breast Cancer, or Uterine Cancer
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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: This randomized phase I trial is studying how well natural supplements and a special diet work in eliminating growth hormones that are made outside the body in patients with early-stage prostate cancer, breast cancer, or uterine cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Prostate Cancer Sarcoma |
Other: laboratory biomarker analysis Procedure: therapeutic dietary intervention |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Gene Expression Control Using Micro-Trace Element Compounds During C.A.M. and Conventional Cancer Protocols |
- Sequestration and elimination of exogenous estrogens from the body using multiple naturally-occurring micro-trace element compounds [ Time Frame: 6 months ] [ Designated as safety issue: No ]lowering body estrogens as related to hormone driven cancer
- Suppression of proliferation-stimulating activities using naturally-occurring flavonoids [ Time Frame: 6 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Monitor levels
- Maintenance of normal metabolic function using a full diet of specifically grown inclusion produce [ Time Frame: 6 months ] [ Designated as safety issue: No ]metabolic function testing
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2013 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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
|
|
Placebo Comparator: Arm II
Patients do not receive natural supplements or consume whole foods or a special diet.
|
Other: laboratory biomarker analysis
No supplements are given
|
Detailed Description:
OBJECTIVES:
- To utilize multiple naturally-occurring micro-trace element compounds to sequester exogenous estrogens from multiple sources, including environmental and metabolic sources, and eliminate them from the body prior to influencing prostate, breast, and uterine cancer pathways.
- To utilize specific naturally-occurring flavonoids to suppress proliferation-stimulating activities induced by normal metabolism and environmental estrogen, estrogen-mimicking, and testosterone compounds.
- To utilize DPPH radical-scavenging activity to reduce secondary bonding of TMPRSS2-ERG fusing and negative-bonded environmental estrogen.
- To utilize a full diet of specifically grown inclusion produce to maintain normal metabolic function.
OUTLINE: Patients are randomized to 1 of 2 arms.
- 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.
- Arm II: Patients do not receive natural supplements or consume whole foods or a special diet.
Levels of compounds of interest are measured by inductively-coupled plasma mass spectrometry, high performance liquid chromatography, gas chromatography, and matrix-assisted laser desorption/ionization time of flight mass spectrometry.
After completion of study therapy, patients are followed periodically for 6 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, Washington | |
| Brabant Research, Incorporated | Not yet recruiting |
| Monroe, Washington, United States, 98272 | |
| Contact: Richard E. Lasker, PhD 360-863-0317 | |
| Principal Investigator: | Richard E. Lasker, PhD | Brabant Research |
More Information
Additional Information:
No publications provided
| 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 25, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Brabant Research:
|
stage I breast cancer stage II breast cancer stage IIIA breast cancer male breast cancer |
stage I uterine sarcoma stage II uterine sarcoma stage I prostate cancer stage II prostate cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Prostatic Neoplasms Sarcoma Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on June 18, 2013