Clinical trial Recruiting at 14 sites Phase 3 Interventional Ages 18 and up

Using Wisconsin ginseng to reduce cancer-related fatigue

Official title: Phase III Study of Ginseng for Cancer Related Fatigue

Run by Mayo Clinic · NCT06395441 · Data updated 2026-11-12

This study is testing if Wisconsin ginseng can help reduce fatigue in cancer patients compared to a placebo over eight weeks.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment222 (estimated)
SponsorMayo Clinic
Academic / other
Drugs / interventionsCAR-T, Chimeric antigen receptor
Locations15 sites (Albert Lea, Minnesota and 14 other locations)
StatusRecruiting
StartedAugust 1, 2024
Main results expectedDecember 30, 2027
Study endsDecember 30, 2027
Registry record updatedOctober 20, 2026
Trial IDNCT06395441 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with a history of cancer-related fatigue and controlled insomnia and pain.

Probably not a fit

Patients with severe fatigue not meeting the study's inclusion criteria or those with uncontrolled symptoms may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III trial evaluates the effectiveness of Wisconsin ginseng (panax quinquefolius) compared to a placebo in alleviating significant fatigue in cancer patients. The primary objective is to measure changes in fatigue levels over an 8-week period using a single-item fatigue measure. Secondary objectives include assessing changes in fatigue at 4 weeks, evaluating patient-reported toxicity, and using the Functional Assessment of Chronic Illness Therapy-Fatigue Scale. Patients will be randomly assigned to receive either ginseng or a placebo for 56 days.

Why it matters

Potential benefit: If successful, this study could provide a new, effective treatment option for managing cancer-related fatigue.

How similar studies have gone: Other studies have shown promise in using ginseng for fatigue management, suggesting potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age ≥ 18 years
* GROUP 1 PARTICIPANTS: Has received or is receiving treatment for a solid-organ malignancy (does not apply to Group 2)
* GROUP 2 PARTICIPANTS: Diagnosis of one of the following hematologic malignancies: Chronic lymphocytic leukemia, Hodgkin lymphoma, non-Hodgkin lymphoma (NHL), multiple myeloma, or survivorship care after completion of therapy for one of the above hematologic malignancies (within 5 years of completion of therapy)
* 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
* GROUP 1 PARTICIPANTS: The following laboratory values obtained ≤ 180 days prior to registration (does not apply to hematologic malignancies)

  * Hemoglobin ≥ 10.0 g/dL (patients must not have been transfused in the preceding 90 days to meet this criterion)
  * Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤ 3 x upper limit normal (ULN)
  * Creatinine ≤ 1.5 x ULN
* GROUP 2 PARTICIPANTS: The following laboratory values obtained ≤ 180 days prior to registration (does not apply to solid-organ malignancies):

  * Hemoglobin ≥ 8.0 g/dL (patients must not have been transfused in the preceding 90 days to meet this criterion)
  * Platelet count ≥ 50,000 cells/mm\^3
  * Absolute neutrophil count ≥ 1000 cells/mm\^3
  * Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤ 3 x ULN
  * Creatinine ≤ 1.5 x ULN
* No clinical suspicion of hypothyroidism within 180 days prior to registration (if clinical suspicion of hypothyroidism exists, a documented thyroid stimulating hormone \[TSH\] \< 5 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

  * Examples of antidiabetic drugs include: Insulin, sulfonylureas, sodium-glucose co-transporter subtype 2 (SGLT2) inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, thiazolidinediones, glucagon-like peptide 1 (GLP-1) receptor agonists/dual incretin agonists, and related agents
* Treating provider anticipates a change to the anti-cancer treatment program in the next 8 weeks (i.e., the intervention period)
* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:

  * Pregnant persons
  * Nursing persons
  * Persons of childbearing potential who are unwilling to employ adequate contraception. (e.g., hormonal methods, barrier methods, intrauterine device, abstinence)
* GROUP 2 PARTICIPANTS: Patients who have been hospitalized (\> 24 hours) in the previous 2 months or who will require hospitalization (for anti-cancer therapy) within the next 3 months
* GROUP 2 PARTICIPANTS: Prior allogeneic transplant
* GROUP 2 PARTICIPANTS: Chimeric antigen receptor T cell (CAR-T), or autologous transplant within the last 180 days
* GROUP 2 PARTICIPANTS: T-cell engager initiation within the last 3 months (patients on stable maintenance dosing are permitted)
* GROUP 2 PARTICIPANTS: Enrolled in another interventional clinical trial

Where it's running

  • Mayo Clinic Health System in Albert Lea
    Albert Lea, Minnesota, United States
    Recruiting
  • Sanford Joe Lueken Cancer Center
    Bemidji, Minnesota, United States
    Recruiting
  • Essentia Health Saint Joseph's Medical Center
    Brainerd, Minnesota, United States
    Recruiting
  • Essentia Health Deer River Clinic
    Deer River, Minnesota, United States
    Recruiting
  • Essentia Health St. Mary's Detroit Lakes Clinic
    Detroit Lakes, Minnesota, United States
    Recruiting
  • Essentia Health Cancer Center
    Duluth, Minnesota, United States
    Recruiting
Show 9 more locations
  • Essentia Health Fosston
    Fosston, Minnesota, United States
    Recruiting
  • Essentia Health Hibbing Clinic
    Hibbing, Minnesota, United States
    Recruiting
  • Mayo Clinic Health System-Mankato
    Mankato, Minnesota, United States
    Recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota, United States
    Recruiting
  • Essentia Health Sandstone
    Sandstone, Minnesota, United States
    Recruiting
  • Sanford Thief River Falls Medical Center
    Thief River Falls, Minnesota, United States
    Recruiting
  • Essentia Health Virginia Clinic
    Virginia, Minnesota, United States
    Recruiting
  • Sanford Worthington Medical Center
    Worthington, Minnesota, United States
    Recruiting
  • MMCORC CentraCare Monticello Cancer Center
    Monticello, Minnesota, United States
    Completed

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.