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

NCT00631852 | Completed Phase 2 Results DMC

• 1 other identifier: PER-SCCI 07-001.1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer, Biomarkers, Ginseng Root

Outcome Measures

Primary Outcomes (19)

• 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

Study Arms (1)

American Ginseng root

EXPERIMENTAL

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

Drug: American Ginseng root

Interventions

American Ginseng root DRUG

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

Also known as: LEAG, Ginseng

American Ginseng root

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southern Illinois University: lead

Study Sites (1)

Simmons Cancer Institute-SIU School of Medicine

Springfield, Illinois, 62702, United States

Location

Related Publications (3)

• 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.

  PMID: 19815237 BACKGROUND

• 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.

  PMID: 18468636 BACKGROUND

• 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.

  PMID: 17011908 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Asian ginseng

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Director of Oncology Clinical Trials
• Organization: Southern Illinois University School of Medicine

krobinson@siumed.edu

217-545-8000

Study Officials

• Elizabeth Peralta, M.D.

  Sutter Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2008
• First Posted: March 10, 2008
• Study Start: February 1, 2008
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: November 11, 2021
• Results First Posted: November 11, 2021

Record last verified: 2021-11

Locations

US (1)