A Phase II Biomarker Trial of Gelatin Encapsulated Extract of American Ginseng Root (LEAG) in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: American Ginseng root
Intervention description: four, 250mg tablets daily 5-14 days prior to surgery
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer, Biomarkers, Ginseng Root

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.
    

Eligibility criteria:

        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