A Phase II Study of an Herbal Decoction That Includes Astragali Radix for Cancer-Associated Anorexia in Patients With Advanced Cancer

Hypothesis: Anorexia and cancer cachexia produce significant loss of adipose tissue and muscle mass and eventually reduce survival in cancer patients. Study design: This phase II study was conducted to assess the efficacy and the safety of an herbal decoction with Astragali Radix in patients with anorexia in advanced cancer. Methods: All patients with histologic evidence of an incurable malignancy had a weight loss of at least 5% during the preceding 6 months and a patient-estimated severe anorexia. The herbal decoction was administered 30 minutes after meals, three times a day for 3 weeks. The score of appetite, body weight, the cytokines, IL-1 beta, IL-6, TNF-alpha, and anthropometric measurements were assessed. For the assessment of anorexia, a visual analog scale (VAS: 0 mm = no anorexia, 100 mm = maximal anorexia) was used. Results: Eleven patients were recruited from January, 2007 to January, 2009. The mean age was 59.8 years old. The change in anorexia from baseline with the herbal decoction was significantly different and anorexia was improved (anorexia VAS score, 60mm vs. 40mm, p = 0.008). The mean value of the maximal body weight was 55.6 kg and differed significantly from the 54.6 kg at baseline (p = 0.009). Changes in cytokine levels and anthropometric measurements from baseline to the 3rd week were not significant. All toxicities were manageable. Conclusion: Appetite and body weight were improved with the herbal decoction. This herbal decoction shows some potential for management of cancer-related anorexia.