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

November 9, 2021 updated by: Southern Illinois University
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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Springfield, Illinois, United States, 62702
        • Simmons Cancer Institute-SIU School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: American Ginseng root
four, 250mg tablets daily 5-14 days prior to surgery
four, 250mg tablets daily 5-14 days prior to surgery
Other Names:
  • LEAG
  • Ginseng

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elizabeth Peralta, M.D., Sutter Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

February 26, 2008

First Submitted That Met QC Criteria

February 29, 2008

First Posted (Estimate)

March 10, 2008

Study Record Updates

Last Update Posted (Actual)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • PER-SCCI 07-001.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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