Wisconsin Ginseng for Decreasing Cancer Related Fatigue

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Malignant Solid Neoplasm

In brief

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.

Key facts

Study ID

NCT06395441

Run by

Mayo Clinic

People needed

160

Starts

2024-08-01

Expected to finish

2026-11-30

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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