Lower, E. E., Fleishman, S., Cooper, A., Zeldis, J., Faleck, H., Yu, Z., & Manning, D. (2009). Efficacy of dexmethylphenidate for the treatment of fatigue after cancer chemotherapy: A randomized clinical trial. Journal of Pain and Symptom Management, 38(5), 650–662.

The study's primary aim was to evaluate the potential therapeutic effect and safety of dexmethylphenidate (d-MPH) in the treatment of patients with chemotherapy-related fatigue. Its secondary aim was to examine the impact of d-MPH on cognitive functioning.

Participants were randomized to a placebo group or an intervention group receiving 5 mg of d-MPH twice daily (10 mg/day total).

• The total number of participants was 154.
• There were 76 participants in the intervention group and 78 in the placebo group.
• The average participant age was 52.8 ± 9.3 years.
• 94.7% of the participants were female and 5.3% were male.
• The majority of participants had breast or ovarian cancer. 

The study took place across 24 academic and community-based cancer centers.

This was a randomized, double-blind, placebo-controlled, parallel-group study.

Cognitive measures were taken with the

• Mini-Mental State Examination (MMSE) for global cognitive functioning
• High Sensitivity Cognitive Screen (HSCS) for memory, language, attention, concentration, visual motor, spatial awareness, and self-regulation
• Modified Swanson, Nelson and Pelham Attention Deficit/Hyperactivity Scale (SNAP).

Other measures were taken with the

• ICD-10 Criteria for fatigue
• Beck Depression Inventory (BDI) for depression
• Clinical Global Impression Scale (CGI-S) for severity of illness
• Functional Assessment of Chronic Illness Therapy - Fatigue Subscale (FACIT-F) for chronic illness and quality of life specific to fatigue symptoms
• ECOG performance status for general well-being. Scores range from 0 (indicating perfect health with no restriction of activities) to 5 (indicating death).

The primary outcome of focus was fatigue. Participants treated with d-MPH had significant improvement in fatigue symptoms at week 8 on the FACIT-F (p = 0.02) and on the CGI-S (p = 0.02). The d-MPH treatment group had higher drug-related events (63% vs. 28%) and greater discontinuation of medication (11% vs. 1.3%) than the placebo group. Cognitive function was not significantly improved.

d-MPH can be of benefit in the treatment of fatigue. However, results do not support d-MPH-mediated reduction in cognitive impairment in adult patients with cancer after chemotherapy.

• The study was underpowered to determine an effect on cognitive functioning.
• HSCS has been reported to be susceptible to practice effects and therefore may have underestimated the level of cognitive impairment in participants.
• The small number of men and the fact that most participants had diagnoses of breast or ovarian cancer limit generalizability.