Recruiting

Phase 3

Wisconsin GinsengWisconsin Ginseng for Decreasing Cancer Related Fatigue

Sponsor:

Mayo Clinic

Code:

NCT06395441

Conditions

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

American Ginseng

Placebo Administration

Questionnaire Administration

Study Details

Brief summary:

This phase III trial compares the effect of Wisconsin ginseng (panax quinquefolius) to placebo in patients with cancer that suffer from significant fatigue. Fatigue is among the most challenging symptoms to manage in patients with cancer, both on or off active treatment. This symptom complex meaningfully contributes to psychosocial distress, healthcare costs, and it also interferes with the delivery of anticancer therapies. American ginseng (Western ginseng) appears to be a promising appearing agent for treating cancer related fatigue. Western ginseng may reduce cancer-related fatigue.

Conditions

Malignant Solid Neoplasm

Study ID

NCT06395441

Start date

Aug 1, 2024

Status verified date

Mar, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Group I (Western ginseng)

Patients receive Western ginseng PO BID on days 1-56. Treatment continues in the absence of disease progression or unacceptable toxicity.

placebo comparator: Group II (placebo)

Patients receive placebo PO BID on days 1-56. Treatment continues in the absence of disease progression or unacceptable toxicity.

Interventions

American Ginseng

Given PO

Placebo Administration

Given PO

Questionnaire Administration

Ancillary studies

Primary outcome measure

Change in fatigue [ Time Frame: Baseline to 8 weeks ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic Health System in Albert Lea

Recruiting

Albert Lea, Minnesota, United States, 56007

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Danielle Mutschler

507-377-4817 Mutschler.Danielle@mayo.edu

Principal Investigator:

Mina Hanna, MD

Sanford Joe Lueken Cancer Center

Recruiting

Bemidji, Minnesota, United States, 56601

Contacts

Jarrett Failing, MD

612-624-2620 ccinfo@umn.edu

Principal Investigator:

Jarrett Failing, MD

Essentia Health Saint Joseph's Medical Center

Recruiting

Brainerd, Minnesota, United States, 56401

Contacts

Bret Friday, MD

612-624-2620 ccinfo@umn.edu

Principal Investigator:

Bret Friday, MD

Essentia Health Deer River Clinic

Recruiting

Deer River, Minnesota, United States, 56636

Contacts

Bret Friday, MD

612-624-2620 ccinfo@umn.edu

Principal Investigator:

Bret Friday, MD

Essentia Health St. Mary's Detroit Lakes Clinic

Recruiting

Detroit Lakes, Minnesota, United States, 56501

Contacts

Bret Friday, MD

612-624-2620 ccinfo@umn.edu

Principal Investigator:

Bret Friday, MD

Essentia Health Cancer Center

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Bret Friday, MD

218-786-3625 ccinfo@umn.edu

Principal Investigator:

Bret Friday, MD

Essentia Health Fosston

Recruiting

Fosston, Minnesota, United States, 56542

Contacts

Bret Friday, MD

612-624-2620 ccinfo@umn.edu

Principal Investigator:

Bret 1 Friday, MD

Essentia Health Hibbing Clinic

Recruiting

Hibbing, Minnesota, United States, 55746

Contacts

Bret Friday, MD

612-624-2620 ccinfo@umn.edu

Principal Investigator:

Bret Friday, MD

Mayo Clinic Health System-Mankato

Recruiting

Mankato, Minnesota, United States, 56001

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Jenna Ziegler

507-594-7479 Ziegler.Jenna@mayo.edu

Principal Investigator:

Stephan Thome, MD

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

Principal Investigator:

Daniel S. Childs, M.D.

Essentia Health Sandstone

Recruiting

Sandstone, Minnesota, United States, 55072

Contacts

Bret Friday, MD

612-624-2620 ccinfo@umn.edu

Principal Investigator:

Bret Friday, MD

Sanford Thief River Falls Medical Center

Recruiting

Thief River Falls, Minnesota, United States, 56701

Contacts

Amit Panwalkar, MD

612-624-2620 ccinfo@umn.edu

Principal Investigator:

Amit Panwalkar, MD

Essentia Health Virginia Clinic

Recruiting

Virginia, Minnesota, United States, 55792

Contacts

Bret Friday, MD

612-624-2620 ccinfo@umn.edu

Principal Investigator:

Bret Friday, MD

Sanford Worthington Medical Center

Recruiting

Worthington, Minnesota, United States, 56187

Contacts

Jonathan Bleeker, MD

jonathan.bleeker@sanfordhealth.org

Principal Investigator:

Jonathan Bleeker, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-30.