title: Methylphenidate and/or a nursing telephone intervention for fatigue in patients with advanced cancer: a randomized, placebo-controlled, phase II trial.
abstract: OBJECTIVE
  Cancer-related-fatigue (CRF) is common in advanced cancer. The primary objective of the study was to compare the effects of methylphenidate (MP) with those of placebo (PL) on CRF as measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue subscale. The effect of a combined intervention including MP plus a nursing telephone intervention (NTI) was also assessed.
  
  
  METHODS
  Patients with advanced cancer with a fatigue score of ≥ 4 out of 10 on the Edmonton Symptom Assessment Scale (ESAS) were randomly assigned to one of the following four groups: MP+NTI, PL+NTI, MP + control telephone intervention (CTI), and PL+CTI. Methylphenidate dose was 5 mg every 2 hours as needed up to 20 mg per day. The primary end point was the median difference in FACIT-F fatigue at day 15. Secondary outcomes included anxiety, depression, and sleep.
  
  
  RESULTS
  One hundred forty-one patients were evaluable. Median FACIT-F fatigue scores improved from baseline to day 15 in all groups: MP+NTI (median score, 4.5; P = .005), PL+NTI (median score, 8.0; P < .001), MP+CTI (median score, 7.0; P = .004), and PL+CTI (median score, 5.0; P = .03). However, there were no significant differences in the median improvement in FACIT-F fatigue between the MP and PL groups (5.5 v 6.0, respectively; P = .69) and among all four groups (P = .16). Fatigue (P < .001), nausea (P = .01), depression (P = .02), anxiety (P = .01), drowsiness (P < .001), appetite (P = .009), sleep (P < .001), and feeling of well-being (P < .001), as measured by the ESAS, significantly improved in patients who received NTI. Grade ≥ 3 adverse events did not differ between MP and PL (40 of 93 patients v 29 of 97 patients, respectively; P = .06).
  
  
  CONCLUSIONS
  MP and NTI alone or combined were not superior to placebo in improving CRF.
authors.affiliation: Department of Palliative Care and Rehabilitation Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA. ebruera@mdanderson.org
authors.forename: Eduardo
authors.initials: E
authors.lastname: Bruera
authors.forename: Sriram
authors.initials: S
authors.lastname: Yennurajalingam
authors.forename: J Lynn
authors.initials: JL
authors.lastname: Palmer
authors.forename: Pedro E
authors.initials: PE
authors.lastname: Perez-Cruz
authors.forename: Susan
authors.initials: S
authors.lastname: Frisbee-Hume
authors.forename: Julio A
authors.initials: JA
authors.lastname: Allo
authors.forename: Janet L
authors.initials: JL
authors.lastname: Williams
authors.forename: Marlene Z
authors.initials: MZ
authors.lastname: Cohen
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000627:therapeutic use*; D003376:Counseling; D003863:Depression / Q000188:drug therapy / Q000451:nursing; D018765:Dopamine Uptake Inhibitors / Q000627:therapeutic use; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology / Q000451:nursing*; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D009367:Neoplasm Staging; D009369:Neoplasms / Q000150:complications* / Q000473:pathology* / Q000628:therapy; D012894:Sleep Stages / Q000187:drug effects; D013689:Telephone; D017211:Treatment Failure
chemical_list: D000697:Central Nervous System Stimulants; D018765:Dopamine Uptake Inhibitors; D008774:Methylphenidate