Trial Outcomes & Findings for A Phase II Biomarker Trial of Gelatin Encapsulated Extract of American Ginseng Root (LEAG) in Breast Cancer (NCT NCT00631852)

NCT ID: NCT00631852

Last Updated: 2021-11-11

Results Overview

Change from baseline to completion of treatment with LEAG.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: mean of 11.8 days
• Results posted on: 2021-11-11

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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.

Baseline characteristics by cohort

Measure	American Ginseng Root n=16 Participants four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
Age, Categorical <=18 years	0 Participants n=16 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=16 Participants
Age, Categorical >=65 years	0 Participants n=16 Participants
Sex: Female, Male Female	16 Participants n=16 Participants
Sex: Female, Male Male	0 Participants n=16 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=16 Participants
Race (NIH/OMB) Asian	0 Participants n=16 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=16 Participants
Race (NIH/OMB) Black or African American	1 Participants n=16 Participants
Race (NIH/OMB) White	15 Participants n=16 Participants
Race (NIH/OMB) More than one race	0 Participants n=16 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=16 Participants
Region of Enrollment United States	16 participants n=16 Participants
Platelet Function Assay (PFA-100)	142.8 seconds n=5 Participants • 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.
BMI	29.3 kg/m^2 STANDARD_DEVIATION 7.7 • n=16 Participants
Glucose	82 mg/dL n=16 Participants
Estrogen Receptor Positivity	7 Participants n=11 Participants • 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.
Progesterone Receptor Positivity	5 Participants n=11 Participants • 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.
HER 2 Positivity	1 Participants n=11 Participants • 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.
Triple Negative Tumors	4 Participants n=11 Participants • 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.

PRIMARY outcome

Timeframe: mean of 11.8 days

Population: 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.

Change from baseline to completion of treatment with LEAG.

Outcome measures

Measure	American Ginseng Root n=11 Participants four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
Adiponectin	1308 pg/ml Standard Deviation 11,985

PRIMARY outcome

Timeframe: mean of 11.8 days

Population: 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.

Mean change from baseline to completion of treatment with LEAG.

Outcome measures

Measure	American Ginseng Root n=11 Participants four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
C Reactive Protein (CRP)	761 pg/ml Standard Deviation 1,347

PRIMARY outcome

Timeframe: mean of 11.8 days

Population: 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.

Mean change from baseline to completion of treatment with LEAG.

Outcome measures

Measure	American Ginseng Root n=11 Participants four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
Hepatocyte Growth Factor (HGF)	1.25 pg/ml Standard Deviation 79.1

PRIMARY outcome

Timeframe: mean of 11.8 days

Population: 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.

Mean change from baseline to completion of treatment with LEAG.

Outcome measures

Measure	American Ginseng Root n=11 Participants four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
Insulin Like Growth Factor 1 (IGF-1)	-144 pg/ml Standard Deviation 478

PRIMARY outcome

Timeframe: 10-14 days

Population: 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.

Mean change from baseline following 10-14 days of treatment with LEAG.

Outcome measures

Measure	American Ginseng Root n=11 Participants four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
Insulin Like Growth Factor 1 Receptor (IGF-1R)	-364 pg/ml Standard Deviation 1502

PRIMARY outcome

Timeframe: mean 11.8 days

Population: 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.

Mean change from baseline to completion of treatment with LEAG.

Outcome measures

Measure	American Ginseng Root n=11 Participants four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
Interlueken-1- (IL-10)	0.1 pg/ml Standard Deviation 0.2

PRIMARY outcome

Timeframe: mean 11.8 days

Population: 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.

Mean change from baseline to completion of treatment with LEAG.

Outcome measures

Measure	American Ginseng Root n=11 Participants four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
IL-12p40	-1 pg/ml Standard Deviation 14

PRIMARY outcome

Timeframe: mean 11.8 days

Population: 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.

Mean change from baseline to completion of treatment with LEAG.

Outcome measures

Measure	American Ginseng Root n=11 Participants four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
IL-1b	5 pg/ml Standard Deviation 13

PRIMARY outcome

Timeframe: mean 11.8 days

Population: 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.

Mean change from baseline to completion of treatment with LEAG.

Outcome measures

Measure	American Ginseng Root n=11 Participants four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
IL-1ra	46 pg/ml Standard Deviation 687

PRIMARY outcome

Timeframe: mean of 11.8 days

Population: 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.

Mean change from baseline to completion of treatment with LEAG.

Outcome measures

Measure	American Ginseng Root n=11 Participants four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
IL-2	2.7 pg/ml Standard Deviation 9.5

PRIMARY outcome

Timeframe: mean 11.8 days

Population: 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.

Mean change from baseline to completion of treatment with LEAG.

Outcome measures

Measure	American Ginseng Root n=11 Participants four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
IL-23	26 pg/ml Standard Deviation 87

PRIMARY outcome

Timeframe: mean 11.8 days

Population: 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.

Mean change from baseline to completion of treatment with LEAG.

Outcome measures

Measure	American Ginseng Root n=11 Participants four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
IL-4	29 pg/ml Standard Deviation 92

PRIMARY outcome

Timeframe: mean 11.8 days

Population: 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.

Mean change from baseline to completion of treatment with LEAG.

Outcome measures

Measure	American Ginseng Root n=11 Participants four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
IL-6	4 pg/ml Standard Deviation 12

PRIMARY outcome

Timeframe: mean 11.8 days

Population: 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.

Mean change from baseline to completion of treatment with LEAG.

Outcome measures

Measure	American Ginseng Root n=11 Participants four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
IL-8	1 pg/ml Standard Deviation 3

PRIMARY outcome

Timeframe: mean 11.8 days

Population: 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.

Mean change from baseline to completion of treatment with LEAG.

Outcome measures

Measure	American Ginseng Root n=11 Participants four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
Insulin	299 pg/ml Standard Deviation 982

PRIMARY outcome

Timeframe: mean 11.8 days

Population: 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.

Mean change from baseline to completion of treatment with LEAG.

Outcome measures

Measure	American Ginseng Root n=11 Participants four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
Leptin	-100 pg/ml Standard Deviation 438

PRIMARY outcome

Timeframe: mean 11.8 days

Population: 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.

Mean change from baseline to completion of treatment with LEAG.

Outcome measures

Measure	American Ginseng Root n=11 Participants four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
MCP-1	8 pg/ml Standard Deviation 20

PRIMARY outcome

Timeframe: mean 11.8 days

Population: 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.

Mean change from baseline to completion of treatment with LEAG.

Outcome measures

Measure	American Ginseng Root n=11 Participants four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
TGFb1	826 pg/ml Standard Deviation 3054

PRIMARY outcome

Timeframe: mean 11.8 days

Population: 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.

Mean change from baseline to completion of treatment with LEAG.

Outcome measures

Measure	American Ginseng Root n=11 Participants four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
TNFa	-15 pg/ml Standard Deviation 51

Adverse Events

American Ginseng Root

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	American Ginseng Root n=16 participants at risk four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
Blood and lymphatic system disorders hemorrhage/ bleeding	6.2% 1/16 • Number of events 1 • 6 weeks

Other adverse events

Measure	American Ginseng Root n=16 participants at risk four, 250mg tablets daily 5-14 days prior to surgery American Ginseng root: four, 250mg tablets daily 5-14 days prior to surgery
General disorders pain	93.8% 15/16 • Number of events 15 • 6 weeks
Nervous system disorders numbness	6.2% 1/16 • Number of events 1 • 6 weeks
General disorders syncope	6.2% 1/16 • Number of events 1 • 6 weeks
Nervous system disorders decreased sensation of digits	6.2% 1/16 • Number of events 1 • 6 weeks
Nervous system disorders coolness in digits	6.2% 1/16 • Number of events 1 • 6 weeks
Eye disorders Floater in eye	6.2% 1/16 • Number of events 1 • 6 weeks
General disorders headache	43.8% 7/16 • Number of events 7 • 6 weeks
General disorders back pain	6.2% 1/16 • Number of events 1 • 6 weeks
Gastrointestinal disorders soar throat	6.2% 1/16 • Number of events 1 • 6 weeks
Respiratory, thoracic and mediastinal disorders injection site reaction	6.2% 1/16 • Number of events 1 • 6 weeks
Respiratory, thoracic and mediastinal disorders decreased oxygen saturation	12.5% 2/16 • Number of events 2 • 6 weeks
Respiratory, thoracic and mediastinal disorders shortness of breath	6.2% 1/16 • Number of events 1 • 6 weeks
Blood and lymphatic system disorders Edema	18.8% 3/16 • Number of events 3 • 6 weeks
Surgical and medical procedures edema	12.5% 2/16 • Number of events 2 • 6 weeks
General disorders Fatigue	18.8% 3/16 • Number of events 3 • 6 weeks
General disorders Hyperactivity	12.5% 2/16 • Number of events 2 • 6 weeks
General disorders Fever	6.2% 1/16 • Number of events 1 • 6 weeks
Gastrointestinal disorders hiccups	6.2% 1/16 • Number of events 1 • 6 weeks
General disorders hot flash	6.2% 1/16 • Number of events 1 • 6 weeks
General disorders Insomnia	12.5% 2/16 • Number of events 2 • 6 weeks
General disorders nightmares	6.2% 1/16 • Number of events 1 • 6 weeks

Additional Information

Director of Oncology Clinical Trials

Southern Illinois University School of Medicine

Phone: 217-545-8000

Email: krobinson@siumed.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place