Cancer Survivor Clinical Trial
Official title:
Ginseng as an Intervention to Decrease Cancer-Related Fatigue in Post-Treatment Cancer Survivors: A Randomized Controlled Pilot Study
This randomized pilot trial studies how well North American ginseng extract AFX-2 (ginseng) works in decreasing cancer-related fatigue after treatment in cancer survivors. Ginseng may decrease fatigue in people who were treated for cancer.
PRIMARY OBJECTIVES: I. To assess the efficacy of ginseng on decreasing cancer-related fatigue (CRF) in post-treatment cancer survivors as measured by Multidimensional Fatigue Symptom Inventory MFSI-Short Form (SF) at 28 and 56 days compared to placebo-controlled group. SECONDARY OBJECTIVES: I. To assess the acceptability and feasibility of ginseng as therapy for CRF in posttreatment cancer survivors. II. To evaluate toxicities and tolerability associated with 2,000 mg per day of North American ginseng extract AFX-2 (panax quinquefolius) when used for cancer-related fatigue. III. To explore the impact of ginseng on secondary endpoints, various dimensions of fatigue as measured by the other subscales of the MFSI-SF, Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form, as well as the single measure of fatigue (captured on Fatigue Linear Analogue Scale). IV. To determine clinically significant changes in fatigue scores per the various measures of fatigue using the global impression of change. TERTIARY OBJECTIVES: I. To explore the relationship between ginseng therapy, inflammation biomarker adiponectin, and post-treatment cancer survivors? fatigue. OUTLINE: Patients are randomized into 1 of 2 groups. GROUP I: Patients receive North American ginseng extract AFX-2 orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. GROUP II: Patients receive placebo PO BID on days 1-28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. At the end of course 2, patients may optionally crossover to Group I to receive ginseng for an additional 28 days. After completion of study, patients are followed up at day 28 and 56. ;
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