| Purpose:Fatigue is one of the most common symptoms experienced by patients with cancer. This trial was developed to evaluate the efficacy of thymosin-al for improving cancer-related fatigue during chemotherapy period.Patients and Methods:Adults cancer patients receiving chemotherapy with 4 of 10 on the Brief Fatigue Inventory (BFI) were eligible. Patients were randomly assigned to receive education with or without thymosin-al (target dose,1.6 mg/BIW) or placebo for 3 weeks. The primary end point was change in the Brief Fatigue Inventory (BFI) subscale from baseline to day 21.Results:In total,43 patients were enrolled. There was no evidence that thymosin-al, as compared with control group, improved the primary end point of general cancer-related fatigue in this patient population (P=0.87). Comparisons of secondary end points, including clinically significant changes in quality-of-life variables and emotion change from baseline, were similarly negative. However, a subset analysis suggested that patients with more severe fatigue did have some fatigue improvement with thymosin-al (P=0.004), and this improvement may occurred in first week after chemotherapy.Conclusion:This clinical trial was unable to support the primary hypothesis that thymosin-al product would decrease general cancer-related fatigue, but can improve worst fatigue. |
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