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A Phase II Biomarker Trial of Gelatin Encapsulated Extract of American Ginseng Root (LEAG) in Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Elizabeth Peralta, MD, Southern Illinois University
ClinicalTrials.gov Identifier:
NCT00631852
First received: February 26, 2008
Last updated: September 2, 2011
Last verified: September 2011
History of Changes
  Purpose

This study was designed to explore the changes brought about by gelatin encapsulated extract of American Ginseng Root (LEAG) in breast cancer tumors and surrounding normal breast epithelial cells. Various tumor biomarkers, as well as inflammatory mediators, will be examined in tissue following LEAG treatment.


Condition Intervention Phase
Breast Cancer
 Dietary Supplement: American Ginseng root
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Biomarker Trial of Gelatin Encapsulated Extract of American Ginseng Root (LEAG) in Breast Cancer

Resource links provided by NLM:

Drug Information available for: Gelatin
U.S. FDA Resources

Further study details as provided by Southern Illinois University:

Primary Outcome Measures:
  • Proliferation and Cytotoxicity Markers [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Correlation between serum ginsenosides and inflammatory mediators [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: February 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ginseng Dietary Supplement: American Ginseng root
four, 250mg tablets daily 5-14 days prior to surgery
Other Names:
  • LEAG
  • Ginseng

Detailed Description:

Asian ginseng (Panax ginseng) and its close relative American ginseng (Panax quinquefolium) are perennial aromatic herbs that are widely used in Asian medicine. Ginseng root is used as a tonic thought to increase the body's resistance to stress and fatigue, to increase endurance under heavy physical activity, and to improve well-being in age-related debilitation. Most of the ginseng consumed, even in Asian populations, is American ginseng, and the majority of American ginseng is grown and processed in Wisconsin, with quality and standardization overseen by the Ginseng Board of Wisconsin. Furthermore, in Asian medicine, Asian ginseng (Panax ginseng) and American ginseng (Panax quinquefolium) are common components in herbals used for cancer prevention and treatment. Indeed, retrospective studies have shown that patients who consumed ginseng on a regular basis experienced cancers at a reduced rate, however, breast cancer was not considered. Ginseng has been used medicinally for over 2000 years and there are no substantiated serious adverse effects, and few, if any, non-serious adverse effects. The World Health Organization lists ginseng as a traditional medicine with very low toxicity. Clinical trials have also demonstrated an anti-hyperglycemic action of American ginseng. These studies utilized capsules containing dried, ground Ontario-grown P. qinquefolius L. root. The ground AG root preparation had an onset of action of 40 minutes. They found no significant increase in anti-hyperglycemic action after 40 minutes and no significant increase in anti-hyperglycemic action using 1 gram versus 3 gram dosing.

LEAG is a standardized preparation of lyophilized water-extract of American ginseng root in 250-mg gelatin capsules. The ginseng was purchased through the Ginseng Board of Wisconsin and the lyophilized extract has been certified for percentage of each and total ginsenoside content and screened for safe levels of minerals, metals, and pesticides by ConsumerLab.com, a leading testing service company of dietary supplements.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with cytologically confirmed breast cancer with biopsy showing invasive or non-invasive (DCIS) at least 1.0 cm greatest diameter on imaging
  • Surgical patients undergoing lumpectomy, subtotal or total mastectomy
  • 18 years of age or greater
  • female
  • available tissue blocks from diagnostic biopsy
  • negative pregnancy test, medical history of surgical sterilization, or 1 year post menopausal
  • must be willing to forego surgery for minimum of 5 days
  • ability and willingness to sign written consent
  • if hypertensive, on stable dose of medication at least 30 days
  • if diabetic, well controlled (HbA1C < 8.5 within past 60 days or documented FPG < 140 mg/dl for 3 consecutive days
  • ECOG status < 2 or Karnofsky of 60% or greater

Exclusion Criteria:

  • previous or current malignancy, excluding non-melanomic skin cancer
  • evidence of distant metastatic disease
  • history of chemotherapy, biologic or radiotherapy with 6 months of biopsy
  • usage of herbal supplements or alternative medications not approved by the FDA within 1 week of starting study drug. LEAG or related ginseng products, and combination products containing ginseng, should be discontinued within 6 weeks of starting study drug
  • history of allergic reactions attributed to compounds of similar chemical or biologic composition to LEAG
  • history of chronic inflammatory process, including, but not limited to, rheumatoid arthritis and lupus. This includes patients on concurrent systemic steroids or anti-inflammatory medications
  • active bleeding or a pathological condition that carries a high risk of bleeding
  • any swallowing dysfunction
  • uncontrolled intercurrent illness
  • poorly controlled diabetes (control indicated with HbA1c < 8.5 within past 60 days or documented fasting blood glucose < 140 mg/dl for three consecutive days)
  • known diabetics who have experienced episodes of symptomatic hypoglycemia in the last 6 months are also considered poorly controlled and will be excluded from study participation.
  • uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHG)
  • pregnant or breast feeding women Women must be willing to use birth control throughout study duration.
  • current investigational medications or treatment with an investigational agent within 6 weeks prior to biopsy
  • current coumadin therapy or who have been treated with coumadin within the 2 weeks prior to biopsy
  • current monoamine oxidase inhibitors treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631852

Locations
United States, Illinois
Simmons Cooper Cancer Institute-SIU School of Medicine
Springfield, Illinois, United States, 62794
Sponsors and Collaborators
Southern Illinois University
Investigators
Principal Investigator: Elizabeth Peralta, M.D. SIU School of Medicine Simmons Cooper Cancer Institute
  More Information

Publications:

Responsible Party: Elizabeth Peralta, MD, Associate Professor, Southern Illinois University
ClinicalTrials.gov Identifier: NCT00631852     History of Changes
Other Study ID Numbers: PER-SCCI 07-001.1
Study First Received: February 26, 2008
Last Updated: September 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Southern Illinois University:
Breast Cancer, Biomarkers, Ginseng Root

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

ClinicalTrials.gov processed this record on May 19, 2013