Bruera, E., Yennurajalingam, S., Palmer, J.L., Perez-Cruz, P.E., Frisbee-Hume, S., Allo, J.A., . . . Cohen, M.Z. (2013). Methylphenidate and/or a nursing telephone intervention for fatigue in patients with advanced cancer: A randomized, placebo-controlled, phase II trial. Journal of Clinical Oncology, 31(19), 2421–2427. 

Compare the effects of methylphenidate (MP) (psychostimulant) with those of a placebo (PL) on cancer-related fatigue. The effect of a combined intervention including MP plus a nursing telephone intervention (NTI) also was assessed.

Patients with a fatigue score of greater than or equal to 4 out of 10 on the Edmonton Symptom Assessment Scale (ESAS) randomly were assigned to one of the following four groups: MP plus NTI, PL plus NTI, MP plus control telephone intervention (CTI), and PL plus CTI.

• N = 141
• MEDIAN AGE = 58 years
• MALES: 33%, FEMALES: 67%
• KEY DISEASE CHARACTERISTICS: Diagnosis of advanced cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Four or above on the ESAS, normal score on the Mini Mental State Examination (MMSE), no severe comorbid conditions including severe anxiety, major depression, substance abuse, or erythropoietin use

• SITE: Multi-site  
• SETTING TYPE: Outpatient  
• LOCATION: Outpatient palliative care and oncology clinics at MD Anderson Cancer Center and at Lyndon B. Johnson General Hospital, both in Houston, TX

• PHASE OF CARE: Mutliple phases of care
• APPLICATIONS: Pediatrics, elder care, palliative care

Randomized, controlled trial; placebo controlled

• Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
• ESAS
• MMSE
• Hospital Anxiety and Depression Scale (HADS)
• Pittsburgh Sleep Quality Index (PSQI)

The groups MP alone, NTI alone, or MP plus NTI proved not significantly better than PL for cancer-related fatigue. Anxiety improved with the telephone intervention (p = .01), as did sleep (p < .001).

MP, used alone or in combination with NTI, was not superior to the control group or the PL for fatigue or depression. NTI was associated with improvement in anxiety and sleep.

• Risk of bias (no blinding)
• No statistical control for multiple comparisons, which could lead to a type one error
• Limited duration of two weeks  
• Content of CTI not described

Although the use of MP did not prove to be effective for cancer-related fatigue, several cancer-related symptoms significantly were improved with NTI. Further research in this area would be ideal, but NTIs remain potentially effective for patient support and education and can have a positive effect on patient experience.