Wisconsin Ginseng for Decreasing Cancer Related Fatigue
Start Date
8/1/2024
Completion Date
11/30/2026
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.
Detailed Description
PRIMARY OBJECTIVE: I. To determine the efficacy of ginseng as assessed by a single item measure of fatigue at 8 weeks. SECONDARY OBJECTIVES: I. To estimate changes in fatigue via the single item measure of fatigue from baseline to week 4, the Global Impression of Change at week 4 and 8, and the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) at week 4 and 8. II. To evaluate the frequency and severity of toxicity as reported by the patient on the Ginseng Symptom Experience Diary where patients rate (on a 0 to 10 scale) their toxicities experienced while on study. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive Western ginseng orally (PO) twice daily (BID) on days 1-56. GROUP II: Patients receive placebo PO BID on days 1-56.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
American Ginseng
Placebo Administration
Questionnaire Administration
Conditions
Locations
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota 56007
United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota 56401
United States
Essentia Health Deer River Clinic
Deer River, Minnesota 56636
United States
Essentia Health St. Mary's Detroit Lakes Clinic
Detroit Lakes, Minnesota 56501
United States
Essentia Health Cancer Center
Duluth, Minnesota 55805
United States
Essentia Health Fosston
Fosston, Minnesota 56542
United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
United States
Mayo Clinic Health System-Mankato
Mankato, Minnesota 56001
United States
MMCORC CentraCare Monticello Cancer Center
Monticello, Minnesota 55362
United States
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States
Essentia Health Sandstone
Sandstone, Minnesota 55072
United States
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota 56701
United States
Essentia Health Virginia Clinic
Virginia, Minnesota 55792
United States
Sanford Worthington Medical Center
Worthington, Minnesota 56187
United States