Lee, J.J., & Lee, J.J. (2010). A phase II study of an herbal decoction that includes Astragali Radix for cancer-associated anorexia in patients with advanced cancer. Integrative Cancer Therapies, 9, 24–31.

To assess the efficacy and safety of an herbal decoction including Astragali Radix in improving appetite and body weight and changing cytokine levels in patients with advanced cancer experiencing anorexia

The herbal decoction consisted of a combination of herbs including Astragali Radix made in the hospital pharmacy every week. The decoction was administered 30 minutes after meals, three times a day for three weeks. The decoction was stopped for treatment refusal, the aggravation of anorexia or weight loss in the midst of therapy, or physician decision. Assessments of appetite were performed at baseline and then weekly until termination of the study. Cytokines were checked at baseline and at the third week.

• The study reported on 11 patients.
• Mean patient age was 59.8 years (range = 42–76 years).
• The sample was 72.7% male and 27.3% female.
• Patients were diagnosed with lung cancer, gastric cancer, or colorectal cancer.
• Use of chemotherapy or radiation therapy was permitted throughout the study period.
• Exclusion criteria included use of tube feedings or parenteral nutrition; simultaneous treatment with adrenal corticosteroids, androgens, progestational agents, or other appetite stimulants; brain metastasis; pregnancy or lactation; and mechanical obstruction of the alimentary tract.

• Single site
• East-West Neomedical Center at Kyung Hee University in Seoul, Republic of Korea

• Patients were undergoing multiple phases of care.
• The study has clinical applicability for end-of-life and palliative care.

A prospective, phase II trial design was used.

Toxicity was assessed as well as tumor response using Recist criteria.

• History and physical exam
• Visual analog scale (VAS) for anorexia
• Body weight
• Skinfold thickness
• Cytokine levels: IL1β, IL-6, TNF-α, and lactate

Primary endpoint: VAS anorexia scores before and after the herbal decoction were significantly improved (p = 0.008). Secondary endpoints: 55% of patients had improvements in both anorexia and body weight at the third week (p = 0.009). The correlation of improvement of anorexia and body weight at the best point was also significantly positive (p = 0.003). The changes in skinfold thickness of the triceps, subscapula, and suprailiac did not significantly change (p = 0.182). The cytokines did not significantly change. Lactate and lactate dehydrogenase (LDH) levels were significantly worse at three weeks. Eight patients were administered the full treatment of the herbal decoction, three patients had the decoction for two weeks, one patient had treatment stopped due to toxicity of concomitant chemotherapy, and two patients had disease progression. Grades 1/2 diarrhea occurred in two patients. Grade 1 dyspepsia occurred in two patients. Grade 1 alanine transaminase abnormality occurred in one patient. Grade 2 neutropenia and grade 2 anemia occurred in two patients who also received concomitant chemotherapy.

This small study demonstrated potential for a combination herbal product to improve anorexia in patients with advanced cancers. Although patients showed significant improvements in anorexia scores and weight gain, cytokine and lactate and LDH values did not improve significantly and in some cases worsened, which is contrary to current thinking regarding the chemical picture of anorexia. Results of this study should be interpreted with caution.

• The study had a small sample size, with less than 30 participants.
• The study was not randomized, so placebo effect cannot be ruled out.
• Cytokines and VAS scores were not evaluated at the same intervals (cytokines were checked at baseline and the third week, and anorexia VAS scores were evaluated at baseline and weekly thereafter). Cytokine changes may have been missed. Changes in anorexia may not have been affected by cytokines.
• The study did not meet its projected accrual number of 30 patients and closed early because of an extended recruitment process. Sample size may have been too small to notice a change in the short period assessed.

Anorexia is a common symptom in patients with cancer. There are some drugs such as corticosteroids and megestrol acetate that can help to control anorexia. Complementary and alternative medicines may help treat cancer-related symptoms. Nurses need to remain knowledgeable about potential medications and complementary agents that may be useful in managing patients’ symptoms.