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CompletedNCT00631852Updated May 12, 2026Results posted

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

A Phase 2 interventional study of American Ginseng root in Breast Cancer, sponsored by Southern Illinois University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Southern Illinois University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Breast Cancer, Biomarkers, Ginseng Root
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 16 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Southern Illinois University is the lead sponsor of 28 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    American Ginseng root

    four, 250mg tablets daily 5-14 days prior to surgery

    Drug: American Ginseng root

Interventions

  • DrugAmerican Ginseng root

    four, 250mg tablets daily 5-14 days prior to surgery

    Also known as: LEAG, Ginseng

06

What researchers measure

Primary outcomes

  1. Adiponectin

    Change from baseline to completion of treatment with LEAG.

    Time frame: mean of 11.8 days

  2. C Reactive Protein (CRP)

    Mean change from baseline to completion of treatment with LEAG.

    Time frame: mean of 11.8 days

  3. Hepatocyte Growth Factor (HGF)

    Mean change from baseline to completion of treatment with LEAG.

    Time frame: mean of 11.8 days

  4. Insulin Like Growth Factor 1 (IGF-1)

    Mean change from baseline to completion of treatment with LEAG.

    Time frame: mean of 11.8 days

  5. Insulin Like Growth Factor 1 Receptor (IGF-1R)

    Mean change from baseline following 10-14 days of treatment with LEAG.

    Time frame: 10-14 days

  6. Interlueken-1- (IL-10)

    Mean change from baseline to completion of treatment with LEAG.

    Time frame: mean 11.8 days

  7. IL-12p40

    Mean change from baseline to completion of treatment with LEAG.

    Time frame: mean 11.8 days

  8. IL-1b

    Mean change from baseline to completion of treatment with LEAG.

    Time frame: mean 11.8 days

  9. IL-1ra

    Mean change from baseline to completion of treatment with LEAG.

    Time frame: mean 11.8 days

  10. IL-2

    Mean change from baseline to completion of treatment with LEAG.

    Time frame: mean of 11.8 days

  11. IL-23

    Mean change from baseline to completion of treatment with LEAG.

    Time frame: mean 11.8 days

  12. IL-4

    Mean change from baseline to completion of treatment with LEAG.

    Time frame: mean 11.8 days

  13. IL-6

    Mean change from baseline to completion of treatment with LEAG.

    Time frame: mean 11.8 days

  14. IL-8

    Mean change from baseline to completion of treatment with LEAG.

    Time frame: mean 11.8 days

  15. Insulin

    Mean change from baseline to completion of treatment with LEAG.

    Time frame: mean 11.8 days

  16. Leptin

    Mean change from baseline to completion of treatment with LEAG.

    Time frame: mean 11.8 days

  17. MCP-1

    Mean change from baseline to completion of treatment with LEAG.

    Time frame: mean 11.8 days

  18. TGFb1

    Mean change from baseline to completion of treatment with LEAG.

    Time frame: mean 11.8 days

  19. TNFa

    Mean change from baseline to completion of treatment with LEAG.

    Time frame: mean 11.8 days

07

Results

Posted Nov 11, 2021

Participant flow

Participant flow — Overall Study
MilestoneAmerican Ginseng Root
Started16
Completed16
Not completed0

Outcome measures

PrimaryAdiponectin

Change from baseline to completion of treatment with LEAG.

Time frame:
mean of 11.8 days
Reported as:
Mean · pg/ml
Adiponectin
pg/mlAmerican Ginseng Root
Adiponectin1308 ± 11.985
PrimaryC Reactive Protein (CRP)

Mean change from baseline to completion of treatment with LEAG.

Time frame:
mean of 11.8 days
Reported as:
Mean · pg/ml
C Reactive Protein (CRP)
pg/mlAmerican Ginseng Root
C Reactive Protein (CRP)761 ± 1,347
PrimaryHepatocyte Growth Factor (HGF)

Mean change from baseline to completion of treatment with LEAG.

Time frame:
mean of 11.8 days
Reported as:
Mean · pg/ml
Hepatocyte Growth Factor (HGF)
pg/mlAmerican Ginseng Root
Hepatocyte Growth Factor (HGF)1.25 ± 79.1
PrimaryInsulin Like Growth Factor 1 (IGF-1)

Mean change from baseline to completion of treatment with LEAG.

Time frame:
mean of 11.8 days
Reported as:
Mean · pg/ml
Insulin Like Growth Factor 1 (IGF-1)
pg/mlAmerican Ginseng Root
Insulin Like Growth Factor 1 (IGF-1)-144 ± 478
PrimaryInsulin Like Growth Factor 1 Receptor (IGF-1R)

Mean change from baseline following 10-14 days of treatment with LEAG.

Time frame:
10-14 days
Reported as:
Mean · pg/ml
Insulin Like Growth Factor 1 Receptor (IGF-1R)
pg/mlAmerican Ginseng Root
Insulin Like Growth Factor 1 Receptor (IGF-1R)-364 ± 1502
PrimaryInterlueken-1- (IL-10)

Mean change from baseline to completion of treatment with LEAG.

Time frame:
mean 11.8 days
Reported as:
Mean · pg/ml
Interlueken-1- (IL-10)
pg/mlAmerican Ginseng Root
Interlueken-1- (IL-10)0.1 ± 0.2
PrimaryIL-12p40

Mean change from baseline to completion of treatment with LEAG.

Time frame:
mean 11.8 days
Reported as:
Mean · pg/ml
IL-12p40
pg/mlAmerican Ginseng Root
IL-12p40-1 ± 14
PrimaryIL-1b

Mean change from baseline to completion of treatment with LEAG.

Time frame:
mean 11.8 days
Reported as:
Mean · pg/ml
IL-1b
pg/mlAmerican Ginseng Root
IL-1b5 ± 13
PrimaryIL-1ra

Mean change from baseline to completion of treatment with LEAG.

Time frame:
mean 11.8 days
Reported as:
Mean · pg/ml
IL-1ra
pg/mlAmerican Ginseng Root
IL-1ra46 ± 687
PrimaryIL-2

Mean change from baseline to completion of treatment with LEAG.

Time frame:
mean of 11.8 days
Reported as:
Mean · pg/ml
IL-2
pg/mlAmerican Ginseng Root
IL-22.7 ± 9.5
PrimaryIL-23

Mean change from baseline to completion of treatment with LEAG.

Time frame:
mean 11.8 days
Reported as:
Mean · pg/ml
IL-23
pg/mlAmerican Ginseng Root
IL-2326 ± 87
PrimaryIL-4

Mean change from baseline to completion of treatment with LEAG.

Time frame:
mean 11.8 days
Reported as:
Mean · pg/ml
IL-4
pg/mlAmerican Ginseng Root
IL-429 ± 92
PrimaryIL-6

Mean change from baseline to completion of treatment with LEAG.

Time frame:
mean 11.8 days
Reported as:
Mean · pg/ml
IL-6
pg/mlAmerican Ginseng Root
IL-64 ± 12
PrimaryIL-8

Mean change from baseline to completion of treatment with LEAG.

Time frame:
mean 11.8 days
Reported as:
Mean · pg/ml
IL-8
pg/mlAmerican Ginseng Root
IL-81 ± 3
PrimaryInsulin

Mean change from baseline to completion of treatment with LEAG.

Time frame:
mean 11.8 days
Reported as:
Mean · pg/ml
Insulin
pg/mlAmerican Ginseng Root
Insulin299 ± 982
PrimaryLeptin

Mean change from baseline to completion of treatment with LEAG.

Time frame:
mean 11.8 days
Reported as:
Median · pg/ml
Leptin
pg/mlAmerican Ginseng Root
Leptin-100 ± 438
PrimaryMCP-1

Mean change from baseline to completion of treatment with LEAG.

Time frame:
mean 11.8 days
Reported as:
Median · pg/ml
MCP-1
pg/mlAmerican Ginseng Root
MCP-18 ± 20
PrimaryTGFb1

Mean change from baseline to completion of treatment with LEAG.

Time frame:
mean 11.8 days
Reported as:
Median · pg/ml
TGFb1
pg/mlAmerican Ginseng Root
TGFb1826 ± 3054
PrimaryTNFa

Mean change from baseline to completion of treatment with LEAG.

Time frame:
mean 11.8 days
Reported as:
Median · pg/ml
TNFa
pg/mlAmerican Ginseng Root
TNFa-15 ± 51

Adverse events

Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
American Ginseng Root0/16 (0%)1/16 (6.3%)15/16 (93.8%)
Most frequent serious events
Most frequent serious events
EventAmerican Ginseng Root
hemorrhage/ bleedingBlood and lymphatic system disorders1/16
Most frequent other events
Showing 10 of 21
Most frequent other events
EventAmerican Ginseng Root
painGeneral disorders15/16
headacheGeneral disorders7/16
EdemaBlood and lymphatic system disorders3/16
FatigueGeneral disorders3/16
decreased oxygen saturationRespiratory, thoracic and mediastinal disorders2/16
edemaSurgical and medical procedures2/16
HyperactivityGeneral disorders2/16
InsomniaGeneral disorders2/16
numbnessNervous system disorders1/16
syncopeGeneral disorders1/16

Baseline characteristics

Platelet assay limited to 5 subjects per protocol. Serum markers limited to 11 subjects due to transfer of specimens to PI at new Institution. Not all subjects provided permission for transfer.

Age, Categorical
Age, Categorical(Participants)American Ginseng Root
<=18 years0
Between 18 and 65 years16
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)American Ginseng Root
Female16
Male0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)American Ginseng Root
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White15
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)American Ginseng Root
United States16
Platelet Function Assay (PFA-100)
Platelet Function Assay (PFA-100)(seconds)American Ginseng Root
Mean142.8 (104 to 160)
BMI
BMI(kg/m^2)American Ginseng Root
Mean29.3 ± 7.7
Glucose
Glucose(mg/dL)American Ginseng Root
Mean82 (61 to 108)
Estrogen Receptor Positivity
Estrogen Receptor Positivity(Participants)American Ginseng Root
Count of participants7

3 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Simmons Cancer Institute-SIU School of Medicine
    Springfield, Illinois 62702, United States
09

References and documents

Publications

  • Peralta EA, Murphy LL, Minnis J, Louis S, Dunnington GL. American Ginseng inhibits induced COX-2 and NFKB activation in breast cancer cells. J Surg Res. 2009 Dec;157(2):261-7. doi: 10.1016/j.jss.2009.05.011. Epub 2009 Jun 6. PubMed 19815237 ↗
  • Peralta EA, Brewer AT, Louis S, Dunnington GL. Vitamin E increases biomarkers of estrogen stimulation when taken with tamoxifen. J Surg Res. 2009 May 1;153(1):143-7. doi: 10.1016/j.jss.2008.03.030. Epub 2008 Apr 22. PubMed 18468636 ↗
  • Peralta EA, Viegas ML, Louis S, Engle DL, Dunnington GL. Effect of vitamin E on tamoxifen-treated breast cancer cells. Surgery. 2006 Oct;140(4):607-14; discussion 614-5. doi: 10.1016/j.surg.2006.07.007. Epub 2006 Sep 6. PubMed 17011908 ↗

Study documents

  • Protocol and statistical analysis plan · Jun 5, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00631852
Lead sponsor
Southern Illinois University
Responsible party
Sponsor
First posted
Mar 10, 2008
Start date
Feb 2008
Primary completion
Jun 30, 2019
Completion
Jun 30, 2019
Results posted
Nov 11, 2021
Last update
May 12, 2026

Study contacts

Elizabeth Peralta, M.D.
principal investigator · Sutter Health

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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