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

This study has been withdrawn prior to enrollment.
(PI moved to different institution)
Sponsor:
Information provided by (Responsible Party):
Southern Illinois University
ClinicalTrials.gov Identifier:
NCT00631852
First received: February 26, 2008
Last updated: November 21, 2014
Last verified: November 2014

February 26, 2008
November 21, 2014
February 2008
March 2016   (final data collection date for primary outcome measure)
Proliferation and Cytotoxicity Markers [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00631852 on ClinicalTrials.gov Archive Site
Correlation between serum ginsenosides and inflammatory mediators [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Phase II Biomarker Trial of Gelatin Encapsulated Extract of American Ginseng Root (LEAG) in Breast Cancer
A Phase II Biomarker Trial of Gelatin Encapsulated Extract of American Ginseng Root (LEAG) in Breast Cancer

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: American Ginseng root
four, 250mg tablets daily 5-14 days prior to surgery
Other Names:
  • LEAG
  • Ginseng
Experimental: American Ginseng root
four, 250mg tablets daily 5-14 days prior to surgery
Intervention: Drug: American Ginseng root

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2016
March 2016   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00631852
PER-SCCI 07-001.1
Yes
Southern Illinois University
Southern Illinois University
Not Provided
Principal Investigator: Elizabeth Peralta, M.D. Sutter Health
Southern Illinois University
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP