Wisconsin Ginseng for Decreasing Cancer Related Fatigue (NCT06395441)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (14 items) and avoid the listed exclusions (11 items).
Location: Mayo Clinic Health System in Albert Lea — Albert Lea, Minnesota
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (15 Sites)
- Mayo Clinic Health System in Albert Lea — Albert Lea, Minnesota
- Sanford Joe Lueken Cancer Center — Bemidji, Minnesota
- Essentia Health Saint Joseph's Medical Center — Brainerd, Minnesota
- Essentia Health Deer River Clinic — Deer River, Minnesota
- Essentia Health St. Mary's Detroit Lakes Clinic — Detroit Lakes, Minnesota
- Essentia Health Cancer Center — Duluth, Minnesota
- Essentia Health Fosston — Fosston, Minnesota
- Essentia Health Hibbing Clinic — Hibbing, Minnesota
- Mayo Clinic Health System-Mankato — Mankato, Minnesota
- MMCORC CentraCare Monticello Cancer Center — Monticello, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota
- Essentia Health Sandstone — Sandstone, Minnesota
- Sanford Thief River Falls Medical Center — Thief River Falls, Minnesota
- Essentia Health Virginia Clinic — Virginia, Minnesota
- Sanford Worthington Medical Center — Worthington, Minnesota
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.