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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| American Ginseng root | Experimental | four, 250mg tablets daily 5-14 days prior to surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| American Ginseng root | Drug | four, 250mg tablets daily 5-14 days prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Peralta, M.D. | Sutter Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simmons Cancer Institute-SIU School of Medicine | Springfield | Illinois | 62702 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19815237 | Background | 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. | |
| 18468636 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | American Ginseng Root | four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Platelet assay limited to 5 subjects per protocol. Serum markers limited to 11 subjects due to transfer of specimens to PI at new Institution. Not all subjects provided permission for transfer.
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| ID | Title | Description |
|---|---|---|
| BG000 | American Ginseng Root | four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adiponectin | Change from baseline to completion of treatment with LEAG. | 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. | Posted | Mean | Standard Deviation | pg/ml | mean of 11.8 days |
|
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | American Ginseng Root | four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hemorrhage/ bleeding | Blood and lymphatic system disorders | Non-systematic Assessment | Pt had episode of increased bleeding in JP drain after mastectomy + reconstruction. Output >250mL over a 2 hours on post-op day 5. Pt returned to OR on post-op day 6 for evacuation of hematoma & discharged post op day 7. Resolved by post-op day 12. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain | General disorders | Systematic Assessment | Pain at surgical incision site |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Oncology Clinical Trials | Southern Illinois University School of Medicine | 217-545-8000 | krobinson@siumed.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2018 | May 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000713447 | Asian ginseng |
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| 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 |
| 17011908 | 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. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Platelet Function Assay (PFA-100) | The first 5 patients enrolled had platelet function assessed prior to surgery with an interim analysis of platelet function and bleeding complications prior to additional patient enrollment to determine if platelet function should be evaluated in all study patients. After 5 patients completed the study protocol, a safety meeting was convened and determined that pre-operative platelet function assessment was not needed in all study patients. | Mean | Full Range | seconds |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Glucose | Mean | Full Range | mg/dL |
|
| Estrogen Receptor Positivity | Data 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' approved transfer of source documents to new Institution. | Count of Participants | Participants |
|
| Progesterone Receptor Positivity | ata 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' approved transfer of source documents to new Institution. | Count of Participants | Participants |
|
| HER 2 Positivity | ata 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' approved transfer of source documents to new Institution. | Count of Participants | Participants |
|
| Triple Negative Tumors | ata 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' approved transfer of source documents to new Institution. | Count of Participants | Participants |
|
|
|
| Primary | C Reactive Protein (CRP) | Mean change from baseline to completion of treatment with LEAG. | 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. | Posted | Mean | Standard Deviation | pg/ml | mean of 11.8 days |
|
|
|
| Primary | Hepatocyte Growth Factor (HGF) | Mean change from baseline to completion of treatment with LEAG. | 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. | Posted | Mean | Standard Deviation | pg/ml | mean of 11.8 days |
|
|
|
| Primary | Insulin Like Growth Factor 1 (IGF-1) | Mean change from baseline to completion of treatment with LEAG. | 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. | Posted | Mean | Standard Deviation | pg/ml | mean of 11.8 days |
|
|
|
| Primary | Insulin Like Growth Factor 1 Receptor (IGF-1R) | Mean change from baseline following 10-14 days of treatment with LEAG. | 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. | Posted | Mean | Standard Deviation | pg/ml | 10-14 days |
|
|
|
| Primary | Interlueken-1- (IL-10) | Mean change from baseline to completion of treatment with LEAG. | 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. | Posted | Mean | Standard Deviation | pg/ml | mean 11.8 days |
|
|
|
| Primary | IL-12p40 | Mean change from baseline to completion of treatment with LEAG. | 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. | Posted | Mean | Standard Deviation | pg/ml | mean 11.8 days |
|
|
|
| Primary | IL-1b | Mean change from baseline to completion of treatment with LEAG. | 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. | Posted | Mean | Standard Deviation | pg/ml | mean 11.8 days |
|
|
|
| Primary | IL-1ra | Mean change from baseline to completion of treatment with LEAG. | 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. | Posted | Mean | Standard Deviation | pg/ml | mean 11.8 days |
|
|
|
| Primary | IL-2 | Mean change from baseline to completion of treatment with LEAG. | 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. | Posted | Mean | Standard Deviation | pg/ml | mean of 11.8 days |
|
|
|
| Primary | IL-23 | Mean change from baseline to completion of treatment with LEAG. | 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. | Posted | Mean | Standard Deviation | pg/ml | mean 11.8 days |
|
|
|
| Primary | IL-4 | Mean change from baseline to completion of treatment with LEAG. | 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. | Posted | Mean | Standard Deviation | pg/ml | mean 11.8 days |
|
|
|
| Primary | IL-6 | Mean change from baseline to completion of treatment with LEAG. | 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. | Posted | Mean | Standard Deviation | pg/ml | mean 11.8 days |
|
|
|
| Primary | IL-8 | Mean change from baseline to completion of treatment with LEAG. | 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. | Posted | Mean | Standard Deviation | pg/ml | mean 11.8 days |
|
|
|
| Primary | Insulin | Mean change from baseline to completion of treatment with LEAG. | 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. | Posted | Mean | Standard Deviation | pg/ml | mean 11.8 days |
|
|
|
| Primary | Leptin | Mean change from baseline to completion of treatment with LEAG. | 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. | Posted | Median | Standard Deviation | pg/ml | mean 11.8 days |
|
|
|
| Primary | MCP-1 | Mean change from baseline to completion of treatment with LEAG. | 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. | Posted | Median | Standard Deviation | pg/ml | mean 11.8 days |
|
|
|
| Primary | TGFb1 | Mean change from baseline to completion of treatment with LEAG. | 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. | Posted | Median | Standard Deviation | pg/ml | mean 11.8 days |
|
|
|
| Primary | TNFa | Mean change from baseline to completion of treatment with LEAG. | 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. | Posted | Median | Standard Deviation | pg/ml | mean 11.8 days |
|
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|
| 0 |
| 16 |
| 1 |
| 16 |
| 15 |
| 16 |
|
| numbness | Nervous system disorders | Systematic Assessment | numbness in arm at surgical drain site. |
|
| syncope | General disorders | Systematic Assessment | dizziness ann syncope |
|
| decreased sensation of digits | Nervous system disorders | 1 | Systematic Assessment | lack of feeling in 2nd and 3rd digits bilaterally. |
|
| coolness in digits | Nervous system disorders | Systematic Assessment | Coolness/ feeling cold in 2nd and 3rd digits bilaterally. |
|
| Floater in eye | Eye disorders | Systematic Assessment | Visual sensation of a "floater" in right eye. |
|
| headache | General disorders | Systematic Assessment | headache |
|
| back pain | General disorders | Systematic Assessment | pain in back. |
|
| soar throat | Gastrointestinal disorders | Systematic Assessment | pain in throat. |
|
| injection site reaction | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Injection site reaction resulting in airway obstruction from IV morphine sulfphate. |
|
| decreased oxygen saturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | O2 saturation dropped below 90%. |
|
| shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | shortness of breath as perceived by patient. |
|
| Edema | Blood and lymphatic system disorders | Systematic Assessment | Edema of upper extremity following surgery. |
|
| edema | Surgical and medical procedures | Systematic Assessment | Edema at surgical and reconstructive sites. |
|
| Fatigue | General disorders | Systematic Assessment | Feeling of tiredness. |
|
| Hyperactivity | General disorders | Systematic Assessment | Feeling of excessive energy and need to keep moving. |
|
| Fever | General disorders | Systematic Assessment |
|
| hiccups | Gastrointestinal disorders | Systematic Assessment |
|
| hot flash | General disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
|
| nightmares | General disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |