Lee, E.Q., Muzikansky, A., Drappatz, J., Kesari, S., Wong, E.T., Fadul, C.E., . . . Wen, P.Y. (2016). A randomized, placebo-controlled pilot trial of armodafinil for fatigue in patients with gliomas undergoing radiotherapy. Neuro-Oncology, 18, 849–854. 

To evaluate if armodafinil versus placebo reduced fatigue and improved quality of life when measured via the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale at baseline and 42 days.

Prior to starting treatment, participants completed several questionnaires rating fatigue and quality of life. The participants were randomly assigned 1:1 to the armodafinil group or placebo group, and questionnaires were completed again at day 22, day 43, and day 56, with the primary end point being day 43, as this was the end of radiation therapy for most patients enrolled. Participants in the armodafinil group received 150 mg daily for eight weeks.

• N = 62   
• AGE RANGE =19–79 years; armodafinil group (median = 56 years), placebo group (median = 54 years)
• MALES: 55.6%, FEMALES: 44.4%
• CURRENT TREATMENT: Chemotherapy, radiation
• KEY DISEASE CHARACTERISTICS: Grade 2–4 glioma, grade 4 most common, receiving 50–60 Gy radiation therapy total
• OTHER KEY SAMPLE CHARACTERISTICS: Karnofsky score greater than 60, ability to read and write in English, no history of major mental illness. The majority of patients were receiving concomitant temozolomide.

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: Dana–Farber Cancer Institute, Boston, MA

PHASE OF CARE: Active antitumor treatment

Randomized, placebo-controlled, pilot trial

• Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
• FACT-General (FACT-G)
• Brief Fatigue Inventory (BFI)
• Cancer Fatigue Scale (CFS)
• Beck Depression Inventory (BDI)

No statistically significant findings using any questionnaire were reported between the treatment arm and the placebo arm at any point measured (day 21, 42, or 26).

Based on this study, one can conclude that armodafinil is not effective in reducing fatigue or improving quality of life in this patient population. It would be helpful to know if the FACIT-F questionnaire has been used in this patient population previously with no concurrent interventions.

• Small sample (< 100)
• Risk of bias (no blinding)
• Findings not generalizable

The findings of this study indicate that more education regarding the multiple factors that can cause fatigue in this patient population is needed, as well as tools to measure this fatigue more effectively to better gauge interventions. The study stated that fatigue is reported during radiation therapy in this patient population, but the questionnaires used did not capture that.