Davis, M., Lasheen, W., Walsh, D., Mahmoud, F., Bicanovsky, L., & Lagman, R. (2012). A phase II dose titration study of thalidomide for cancer-associated anorexia. Journal of Pain and Symptom Management, 43, 78–86.

To assess appetite response to thalidomide in cancer-associated anorexia

Patients with advanced cancer were given 50 mg of thalidomide at bedtime for two weeks. Those who responded to treatment were kept on the same dose for a total of six weeks. Those who did not respond to the 50 mg dose and were not experiencing dose-limiting toxicity were given 100 mg at night for two more weeks. If there was no response at 100 mg after two weeks and the patient was not having dose-limiting toxicity, the dose was escalated to 200 mg at bedtime.

• The study reported on a sample of 33 patients.  
• Median patient age was 69 years, with a range of 43–87 years.
• The sample was 51% male and 49% female.
• Patients had advanced, active cancer.

• Single site
• Outpatient setting
• United States

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

A prospective, observational study design was used.

• Medical history
• Neurologic exam
• Appetite, strength, pain, insomnia, night sweats, and nausea measured by 0–10 numerical rating scale (NRS)
• Appetite, tiredness, early satiety, quality of life, and toxicities (muscle cramps, pain, confusion, constipation, dizziness, drowsiness, dry mouth, headache, loss of interest in sex, nervousness, stomach pain, dry skin or pruritius, and limb swelling) measured by categorical scale (patient-perceived severity by a categorical scale [CAT])
• Eastern Cooperative Oncology Group–PS (performance score)
• Weight
• C-reactive protein (CRP)
• Lean body mass by Bioelectric Impedance (BIA)

Thirty-three patients completed at least 14 days of therapy. Sixty-four percent of patients who had completed at least two weeks of thalidomide had statistically significant appetite improvement by both the NRS and CAT (p < 0.001). Other symptoms with statistically significant improved scores included pain (< 0.05), insomnia (night sleep) (< 0.01), and early satiety (< 0.05).

Thalidomide significantly improved appetite, insomnia, pain, and early satiety from baseline in patients with advanced cancer.

• The study count is not clear as to how long patients were on which dose of thalidomide. Thirty-three patients received 50 mg for 14 days. At that time, 17 had improved appetite and 9 of the 16 nonresponders were titrated up to 100 mg. At this point it is not clear what happened with the other seven patients, but the study goes on to say that seven withdrew after two weeks, suggesting that the seven who dropped out received the 100 mg dose, which the manuscript does not corroborate. Although the methods stated that patients were titrated up to 200 mg, the results do not mention this.  
• The study states that side effects were \"negligible,\" yet at least 5 of 33 patients dropped out of the study due to side effects.  
• There was no control group for this study. Some of the lack of response to the study drug could have been due to disease progression or performance status deterioration. A larger study with a control group may have provided comparison data to assess this point.
• Adherence to medication administration was not measured.

Thalidomide may provide benefit for appetite stimulation as well as some other symptoms of advanced disease; however, the drug is not without side effects that may interfere with quality of life. This was a small study, partially funded by a pharmaceutical company, so the results should be interpreted with caution. Patients with advanced cancers on thalidomide should be educated about and assessed frequently for toxicities that may erode what little quality of life they have. Nurses must advocate for their patients who are experiencing unacceptable toxicities.