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Ginseng extract studied for breast cancer effects

NCT ID NCT00631852

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Feb 2008

Finished

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

18 years and older

Sex

Female participants only

Healthy volunteers

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

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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