Status:
COMPLETED
A Phase II Biomarker Trial of Gelatin Encapsulated Extract of American Ginseng Root (LEAG) in Breast Cancer
Lead Sponsor:
Southern Illinois University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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. Var...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00631852
Start Date
February 1 2008
End Date
June 30 2019
Last Update
November 11 2021
Active Locations (1)
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1
Simmons Cancer Institute-SIU School of Medicine
Springfield, Illinois, United States, 62702