Phase 2
Completed N=16
A Phase II Biomarker Trial of Gelatin Encapsulated Extract of American Ginseng Root (LEAG) in Breast Cancer
Source: ClinicalTrials.gov NCT00631852 ↗Enrolled (actual)
16
Serious AEs
6.3%
Results posted
Nov 2021
Primary outcomePrimary: Adiponectin — 1308 pg/ml
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adiponectin |
1308 | — |
| PRIMARY C Reactive Protein (CRP) |
761 | — |
| PRIMARY Hepatocyte Growth Factor (HGF) |
1.25 | — |
| PRIMARY Insulin Like Growth Factor 1 (IGF-1) |
-144 | — |
| PRIMARY Insulin Like Growth Factor 1 Receptor (IGF-1R) |
-364 | — |
| PRIMARY Interlueken-1- (IL-10) |
0.1 | — |
| PRIMARY IL-12p40 |
-1 | — |
| PRIMARY IL-1b |
5 | — |
| PRIMARY IL-1ra |
46 | — |
| PRIMARY IL-2 |
2.7 | — |
| PRIMARY IL-23 |
26 | — |
| PRIMARY IL-4 |
29 | — |
| PRIMARY IL-6 |
4 | — |
| PRIMARY IL-8 |
1 | — |
| PRIMARY Insulin |
299 | — |
| PRIMARY Leptin |
-100 | — |
| PRIMARY MCP-1 |
8 | — |
| PRIMARY TGFb1 |
826 | — |
| PRIMARY TNFa |
-15 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00631852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.