Breast CancerPhase 2NCT00631852

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

A Phase 2 study testing American Ginseng root in people with Breast Cancer, run by Southern Illinois University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: American Ginseng root
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: Feb 2008to 30 Jun 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 11Show fewer

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

Who cannot join

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

Show all 16Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

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.

Conditions: Breast Cancer
Being tested: American Ginseng root
Keywords: Breast Cancer, Biomarkers, Ginseng Root
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

American Ginseng rootDrug
Also called LEAG, Ginseng
four, 250mg tablets daily 5-14 days prior to surgery

Study groups in NCT00631852
Study group	Role	What they receive
American Ginseng root	Experimental	four, 250mg tablets daily 5-14 days prior to surgery Receives: Drug: American Ginseng root

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 200830 Jun 2019

First posted10 Mar 2008 (estimated)
Study startFeb 2008
Primary completion30 Jun 2019
Study completion30 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00631852
Sponsor's protocol ID: PER-SCCI 07-001.1
Status last verified: Nov 2021
First submitted: 26 Feb 2008
Last updated: 12 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Biomarker Trial of Gelatin Encapsulated Extract of American Ginseng Root (LEAG) in Breast Cancer
ClinicalTrials.gov ID: NCT00631852
Acronym / sponsor ID: PER-SCCI 07-001.1
Conditions: Breast Cancer
Keywords: Breast Cancer, Biomarkers, Ginseng Root
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Southern Illinois UniversityUniversity, hospital or other
Study start: Feb 2008
Primary completion: 30 Jun 2019 (actual)
Study completion: 30 Jun 2019 (actual)
First posted: 10 Mar 2008 (estimated)
Results: Posted 11 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
American Ginseng root	Experimental	Drug: American Ginseng rootfour, 250mg tablets daily 5-14 days prior to surgery

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
American Ginseng rootAlso: LEAG, Ginsengfour, 250mg tablets daily 5-14 days prior to surgery	Drug	American Ginseng root

Primary outcome

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

Results and safety

Results posted to the registry on 11 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
American Ginseng Root	16	16

Primary outcome: Adiponectin

Time frame: mean of 11.8 days. Mean (Standard Deviation). Unit: pg/ml

Measure	American Ginseng Root n = 11
Value	1308 (11.985)

Population analysed: Serum markers were analyzed at a later date due to funding issues and PI transfer to new Institution. PI obtained funding through new Institution and only 11 subjects' specimens were able to be transferred to new Institution.

Primary outcome: C Reactive Protein (CRP)

Time frame: mean of 11.8 days. Mean (Standard Deviation). Unit: pg/ml

Measure	American Ginseng Root n = 11
Value	761 (1,347)

Primary outcome: Hepatocyte Growth Factor (HGF)

Time frame: mean of 11.8 days. Mean (Standard Deviation). Unit: pg/ml

Measure	American Ginseng Root n = 11
Value	1.25 (79.1)

Primary outcome: Insulin Like Growth Factor 1 (IGF-1)

Time frame: mean of 11.8 days. Mean (Standard Deviation). Unit: pg/ml

Measure	American Ginseng Root n = 11
Value	-144 (478)

Adverse events

Time frame: 6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
American Ginseng Root	1 of 16 (6.3%)	15 of 16 (93.8%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19815237Peralta 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.
Background: PubMed 18468636Peralta 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.
Background: PubMed 17011908Peralta 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.

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elizabeth Peralta, M.D. principal investigator

Sutter Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing American Ginseng root in people with Breast Cancer, run by Southern Illinois University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adiponectin (time frame: mean of 11.8 days). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00631852, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.