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, 577–583.

DOI Link

Study Purpose

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

Intervention Characteristics/Basic Study Process

Patients were given 5 mg of placebo for the first chemotherapy cycle to assess for compliance and were then randomized to either d-MPH 5 mg twice daily (BID) or matched placebo. The dosage increased to 10 mg BID after one week and was taken in the morning and at noon.

Sample Characteristics

  • The sample was comprised of 57 women with breast cancer.
  • Median age was 50 years. 
  • Of the patients, 29 received d-MPH and 28 received placebo.
  • Patients were eligible for the study if they were receiving four cycles of standard adjuvant chemotherapy.

Setting

  • Multisite
  • Three hospital outpatient clinics in Toronto, Canada

Study Design

The study was a randomized, controlled trial with a placebo arm.

Measurement Instruments/Methods

  • High Sensitivity Cognitive Screen (HSCS)
  • Hopkins Learning Test–Revised (HLT-R)
  • Functional Assessment of Cancer Therapy–General (FACT-G)
  • FACT–Fatigue (FACT-F) 
  • Mini-Mental State Examination (MMSE)

All were measured at baseline, end of chemotherapy, and at six-month follow-up.

Results

The difference between groups was not significant in cognitive function or fatigue.

Conclusions

The findings do not support the effectiveness of d-MPH at the doses given here in reducing fatigue during active treatment for breast cancer.

Limitations

  • The study had a small sample size, with less than 100 patients. 
  • The study was underpowered; no trends suggest that d-MPH taken concurrently with adjuvant chemotherapy improves quality of life or fatigue.

Nursing Implications

D-MPH cannot be suggested as an intervention to relieve cancer-related fatigue or cognitive functioning.