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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: American Ginseng root


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: American Ginseng root<br>four, 250mg tablets daily 5-14 days prior to surgery | Drug: American Ginseng root<br>* four, 250mg tablets daily 5-14 days prior to surgery<br>* Other names: Ginseng;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adiponectin | Change from baseline to completion of treatment with LEAG. | mean of 11.8 days | 
| C Reactive Protein (CRP) | Mean change from baseline to completion of treatment with LEAG. | mean of 11.8 days | 
| Hepatocyte Growth Factor (HGF) | Mean change from baseline to completion of treatment with LEAG. | mean of 11.8 days | 
| Insulin Like Growth Factor 1 (IGF-1) | Mean change from baseline to completion of treatment with LEAG. | mean of 11.8 days | 
| Insulin Like Growth Factor 1 Receptor (IGF-1R) | Mean change from baseline following 10-14 days of treatment with LEAG. | 10-14 days | 
| Interlueken-1- (IL-10) | Mean change from baseline to completion of treatment with LEAG. | mean 11.8 days | 
| IL-12p40 | Mean change from baseline to completion of treatment with LEAG. | mean 11.8 days | 
| IL-1b | Mean change from baseline to completion of treatment with LEAG. | mean 11.8 days | 
| IL-1ra | Mean change from baseline to completion of treatment with LEAG. | mean 11.8 days | 
| IL-2 | Mean change from baseline to completion of treatment with LEAG. | mean of 11.8 days | 
| IL-23 | Mean change from baseline to completion of treatment with LEAG. | mean 11.8 days | 
| IL-4 | Mean change from baseline to completion of treatment with LEAG. | mean 11.8 days | 
| IL-6 | Mean change from baseline to completion of treatment with LEAG. | mean 11.8 days | 
| IL-8 | Mean change from baseline to completion of treatment with LEAG. | mean 11.8 days | 
| Insulin | Mean change from baseline to completion of treatment with LEAG. | mean 11.8 days | 
| Leptin | Mean change from baseline to completion of treatment with LEAG. | mean 11.8 days | 
| MCP-1 | Mean change from baseline to completion of treatment with LEAG. | mean 11.8 days | 
| TGFb1 | Mean change from baseline to completion of treatment with LEAG. | mean 11.8 days | 
| TNFa | Mean change from baseline to completion of treatment with LEAG. | mean 11.8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Biomarkers, Ginseng Root