Ginseng extract studied for breast cancer effects
NCT ID NCT00631852
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether an extract of American ginseng root (LEAG) could change certain markers in breast cancer tumors. Sixteen women took ginseng tablets for 5–14 days before their surgery. Researchers measured changes in inflammation and growth-related proteins in the tumor tissue. This was a very small, early-stage study focused on biological effects, not on treating or curing cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- American ginseng root extract (LEAG)
- What this could lead to
- If successful, this could point toward a natural supplement that might influence breast cancer biology, but it is not a treatment.
- What could go wrong
- This is a very small, early-phase study (16 people) looking at biomarkers, not survival or cure. Results may not lead to any clinical benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
16 people
The number who actually took part.
- Start date
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Feb 2008
- Finished
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Jun 2019
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Simmons Cancer Institute-SIU School of Medicine
Springfield, Illinois, 62702, United States
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