Phase III Study of Ginseng for Cancer Related Fatigue
Mayo Clinic
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.
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 stu…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Dietary SupplementAmerican Ginseng
Given PO
- DrugPlacebo Administration
Given PO
- OtherQuestionnaire Administration
Ancillary studies
Locations (15)
- Mayo Clinic Health System in Albert LeaAlbert Lea, Minnesota
- Sanford Joe Lueken Cancer CenterBemidji, Minnesota
- Essentia Health Saint Joseph's Medical CenterBrainerd, Minnesota
- Essentia Health Deer River ClinicDeer River, Minnesota
- Essentia Health St. Mary's Detroit Lakes ClinicDetroit Lakes, Minnesota
- Essentia Health Cancer CenterDuluth, Minnesota