Mar Fan, H.G., Clemons, M., Xu, W., Chemerynsky, I., Breunis, H., Braganza, S., & Tannock, I.F. (2008). A randomised, placebo-controlled, double-blind trial of the effects of d-methylphenidate on fatigue and cognitive dysfunction in women undergoing adjuvant chemotherapy for breast cancer. Supportive Care in Cancer, 16(6), 577–583.

To investigate the effects of dexmethylphenidate (d-MPH) on fatigue and cognitive function in women undergoing adjuvant chemotherapy for early breast cancer

Participants were randomized to a placebo group or a treatment group receiving d-MPH. The treatment group was started on 5 mg twice a day of d-MPH. If this was well-tolerated, the dose was increased one week later to 10 mg twice a day. The treatment group then continued taking d-MPH at a maximum of 10 mg twice a day until the end of the final cycle of chemotherapy. If participants did not tolerate 10 mg twice a day, the dose was reduced to 5 mg twice a day for the remainder of their treatment.

• The total number of participants was 57.
• The treatment group had 29 participants, and the placebo group had 28 participants.
• The median age of the treatment group was 50, with a range of 36–72.
• The median age of the placebo group was 51, with a range of 37–74.
• All participants were female.
• All participants had breast cancer.
• All participants were scheduled to receive four or more cycles of adjuvant chemotherapy and were enrolled after at least one cycle of chemotherapy.

Three hospital-based outpatient clinics in Toronto, Canada

Prospective, randomized, double-blind, placebo-controlled trial

• Mini-Mental State Examination ((MMSE) for global cognitive functioning
• High Sensitivity Cognitive Screen (HSCS) for memory, language, attention, concentration, visual-motor, spatial, and self-regulation
• Hopkins Verbal Learning Test-Revised (HVLT-R) for immediate and delayed recall (alternate forms used)
• Functional Assessment of Cancer Therapy-General (FACT-G) for cancer-related quality of life
• Functional Assessment of Cancer Therapy (FACT-F) for cancer-related quality of life pertaining to fatigue symptoms
• Hospital Anxiety and Depression Scale (HADS)

No difference was seen between groups on any of the cognitive assessments completed at baseline, end of chemotherapy, and at six-month follow-up.

The study failed to demonstrate a beneficial effect of d-MPH on either fatigue or cognitive dysfunction during adjuvant chemotherapy for breast cancer.

• No baseline assessment of cognitive function was conducted prior to chemotherapy treatment; the baseline assessment was completed after the participant already had received at least one cycle of chemotherapy. 
• No descriptive information was provided regarding the sample (e.g., educational level, disease stage).
• The study was closed early because of failure to achieve the accrual goal. This primarily was due to patient reluctance to take additional medication in general and d-MPH in particular. 
• HSCS is subject to substantial practice effect and is not recommended for serial measures.
• The sample size was insufficient to achieve the necessary statistical power.