Effectiveness Not Established
Research Evidence Summaries
Berenson, J.R., Yellin, O., Shamasunder, H.K., Chen, C.S., Charu, V., Woliver, T.B., . . . Vescio, R. (2014). A phase 3 trial of armodafinil for the treatment of cancer-related fatigue for patients with multiple myeloma. Supportive Care in Cancer. Advance online publication.doi: 10.1007/s00520-014-2486-7
To study effects of armodafinil on cancer-related fatigue in patients with multiple myeloma
Intervention Characteristics/Basic Study Process:
Patients were randomly assigned to study groups in this crossover design study. One group was a treatment-only arm that got armodafinil, and the other was a placebo-first arm that received a placebo followed by armodafinil. Patients received armodafinil 150 mg once daily for 56 days in the treatment-only group. In the other group, patients received a placebo for 28 days and armodafinil on days 29–56. Assessments were done at baseline and at days 15, 28, 43, and 56. Five variations of study assessments were used to address potential memorization effects, and the order in which versions were used was varied.
- SITE: Multi-site
- SETTING TYPE: Not specified
- LOCATION: California
Phase of Care and Clinical Applications:
- PHASE OF CARE: Active antitumor treatment
Double-blind, randomized, crossover-controlled trial
- Brief Fatigue Inventory (BFI)
- Hospital Anxiety and Depression Scale (HADS)
- Epworth sleepiness scale
- Trail Making Test (TMT) version B
- Symbol Digits Modalities Test (SDMT)
- Digit span test
- Functional Assessment of Chronic Illness Scale–Fatigue (FACIT-F)
- Functional Assessment of Cancer Therapy–General (FACIT-G)
Adverse effects observed during armodafinil treatment were similar between groups. Fatigue as measured by the BFI scale decreased significantly for both groups over time with no difference between groups. Outcomes measured by FACIT scores increased significantly in the placebo-first group by day 28, and FACIT fatigue scores improved significantly in both groups. Anxiety decreased significantly from baseline in both groups. Depression scores only declined significantly in the placebo-first group by day 28. Degree of sleepiness decreased significantly in the placebo group. There were no significant changes in study measures between day 28 and day 56 in which all patients received armodafinil.
Armodafinil was not shown to significantly improve symptoms of fatigue, anxiety, or depression in patients with multiple myeloma.
- Small sample (< 100)
- Other limitations/explanation: 20% drop-out rate prior to day 56; more patients in the treatment-only group dropped out.
Armodafinil, a medication similar to modafinil, was not shown to be effective for the reduction of fatigue, anxiety, or depression.