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Ginseng vs. fatigue: major trial tests natural remedy for cancer patients

NCT ID NCT06395441

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase III trial tests whether American ginseng can reduce fatigue in 160 cancer patients. Fatigue is a common and tough side effect of cancer and its treatment. Participants will take either ginseng or a placebo, and researchers will measure changes in fatigue levels over time.

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 (dietary supplement)
What this could lead to
If it works, this could provide a natural option to ease cancer-related fatigue, improving quality of life for many patients.
What could go wrong
This is a large Phase III trial, but fatigue is subjective and the placebo effect is strong. Ginseng may not outperform placebo, and results may not apply to all cancer types.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Nov 2026

An estimate. End dates often move.

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

Anyone

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: * Age ≥ 18 years * Has received or is receiving treatment for a solid-organ malignancy (not hematologic) * History of cancer-related fatigue as defined by an average score ≥ 4 over the past 30 days on the numeric analogue scale. Patients can answer questions orally rather than completing worksheet * Baseline control of insomnia: Insomnia ≤ 4 on Linear Analogue Scale. Patients can answer questions orally rather than completing worksheet * Baseline control of pain: Pain ≤ 4 on Linear Analogue Scale. Patients can answer questions orally rather than completing worksheet * Life expectancy ≥ 6 months * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2 * Hemoglobin ≥ 10.0 g/dL (patients must not have been transfused in the preceding 90 days to meet this criterion) (≤ 180 days prior to registration) * Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤ 3 x upper limit normal (ULN) (≤ 180 days prior to registration) * Creatinine ≤ 1.5 x ULN (≤ 180 days prior to registration) * No clinical suspicion of hypothyroidism within 180 days prior to registration \[if clinical suspicion of hypothyroidism exists, a documented thyroid stimulating hormone (TSH) \< 5 milli-international units per liter (mIU/L) is required\] * Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only * Ability to complete questionnaire(s) by themselves or with assistance * Provide informed consent Exclusion Criteria: * Any known hypersensitivity to ginseng * Currently using any other pharmacologic agents to specifically treat fatigue including psychostimulants or antidepressants. Note: Antidepressants used to treat items other than fatigue (such as hot flashes or depression) are allowed if the patient has been on a stable dose for ≥ 30 days and plan to continue such for 8 weeks. Exercise is allowed * Psychiatric disorder such as poorly controlled depression, manic depressive disorder, obsessive compulsive disorder, or schizophrenia (defined per medical history) * Use of erythropoietic agents ≤ 6 months * Uncontrolled hypertension on more than three occasions (diastolic blood pressure ≥ 100, systolic ≥ 160) measured ≤ 180 days prior to randomization * Surgery that required general anesthetic ≤ 30 days prior to randomization * Malnutrition, active infection, severe depression, or significant pulmonary disease and cardiovascular disease (as determined by the attending clinician), as they could impact fatigue * Use of any over the counter herbal/dietary supplement marketed for fatigue or energy (for example, products containing any type of ginseng, Rhodiola rosea, guarana, or anything called an "adaptogen") * Currently using an antidiabetic drug, warfarin or monamine oxide inhibitor * Treating provider anticipates a change to the anti-cancer treatment program in the next 8 weeks (i.e., the intervention period)

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    14 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Essentia Health Cancer Center

    RECRUITING

    Duluth, Minnesota, 55805, United States

    Contact Email: •••••@•••••

  • Essentia Health Deer River Clinic

    RECRUITING

    Deer River, Minnesota, 56636, United States

    Contact Email: •••••@•••••

  • Essentia Health Fosston

    RECRUITING

    Fosston, Minnesota, 56542, United States

    Contact Email: •••••@•••••

  • Essentia Health Hibbing Clinic

    RECRUITING

    Hibbing, Minnesota, 55746, United States

    Contact Email: •••••@•••••

  • Essentia Health Saint Joseph's Medical Center

    RECRUITING

    Brainerd, Minnesota, 56401, United States

    Contact Email: •••••@•••••

  • Essentia Health Sandstone

    RECRUITING

    Sandstone, Minnesota, 55072, United States

    Contact Email: •••••@•••••

  • Essentia Health St. Mary's Detroit Lakes Clinic

    RECRUITING

    Detroit Lakes, Minnesota, 56501, United States

    Contact Email: •••••@•••••

  • Essentia Health Virginia Clinic

    RECRUITING

    Virginia, Minnesota, 55792, United States

    Contact Email: •••••@•••••

  • MMCORC CentraCare Monticello Cancer Center

    COMPLETED

    Monticello, Minnesota, 55362, United States

  • Mayo Clinic Health System in Albert Lea

    RECRUITING

    Albert Lea, Minnesota, 56007, United States

    Contact Email: •••••@•••••

  • Mayo Clinic Health System-Mankato

    RECRUITING

    Mankato, Minnesota, 56001, United States

    Contact Email: •••••@•••••

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

  • Sanford Joe Lueken Cancer Center

    RECRUITING

    Bemidji, Minnesota, 56601, United States

    Contact Email: •••••@•••••

  • Sanford Thief River Falls Medical Center

    RECRUITING

    Thief River Falls, Minnesota, 56701, United States

    Contact Email: •••••@•••••

  • Sanford Worthington Medical Center

    RECRUITING

    Worthington, Minnesota, 56187, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.