NCT06395441

Wisconsin Ginseng for Decreasing Cancer Related Fatigue

Phase III Study of Ginseng for Cancer Related Fatigue

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Solid Neoplasm

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	American Ginseng	Given PO
DRUG	Placebo Administration	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2024-05-02
• Last updated: 2026-03-30

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study