Phase III Study of Ginseng for Cancer Related Fatigue
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.
Arms & interventions
- Dietary SupplementAmerican Ginseng
Given PO
- DrugPlacebo Administration
Given PO
- OtherQuestionnaire Administration
Ancillary studies
Outcome measures
Primary
Change in fatigue
Will be measured by the Linear Analog Scale for Fatigue, a single-item questionnaire rating fatigue over the pats week on a scale of 0-10 where 0=no fatigue at all and 10=fatigue as bad as it can be.
Time frame: Baseline to 8 weeks
Secondary
Change in fatigue
Time frame: Baseline, 4 and 8 weeks
Percentage of patients who perceive moderate to very much better fatigue
Time frame: At 8 weeks
Incidence of adverse events
Time frame: Up to 8 weeks
Eligibility criteria
Study locations (15)
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Essentia Health Deer River Clinic
Deer River, Minnesota, 56636
Essentia Health St. Mary's Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Essentia Health Fosston
Fosston, Minnesota, 56542
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Mayo Clinic Health System-Mankato
Mankato, Minnesota, 56001
MMCORC CentraCare Monticello Cancer Center
Monticello, Minnesota, 55362
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, 56701
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Sanford Worthington Medical Center
Worthington, Minnesota, 56187