Methylphenidate and/or a nursing telephone intervention for fatigue in patients with advanced cancer: A randomized, placebo-controlled, phase II trial

Eduardo Bruera, Sriram Yennurajalingam, J. Lynn Palmer, Pedro E. Perez-Cruz, Susan Frisbee-Hume, Julio A. Allo, Janet L. Williams, Marlene Z. Cohen

Research output: Contribution to journalArticle

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Abstract

Purpose: 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. Patients and 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). Conclusion: MP and NTI alone or combined were not superior to placebo in improving CRF.

Original languageEnglish (US)
Pages (from-to)2421-2427
Number of pages7
JournalJournal of Clinical Oncology
Volume31
Issue number19
DOIs
StatePublished - Jul 1 2013

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Methylphenidate
Telephone
Fatigue
Nursing
Placebos
Neoplasms
Chronic Disease
Symptom Assessment
Sleep
Anxiety
Depression
Sleep Stages
Appetite
Nausea
Emotions

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

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. https://doi.org/10.1200/JCO.2012.45.3696

Methylphenidate and/or a nursing telephone intervention for fatigue in patients with advanced cancer : A randomized, placebo-controlled, phase II trial. / Bruera, Eduardo; Yennurajalingam, Sriram; Palmer, J. Lynn; Perez-Cruz, Pedro E.; Frisbee-Hume, Susan; Allo, Julio A.; Williams, Janet L.; Cohen, Marlene Z.

In: Journal of Clinical Oncology, Vol. 31, No. 19, 01.07.2013, p. 2421-2427.

Research output: Contribution to journalArticle

Bruera, E, Yennurajalingam, S, Palmer, JL, Perez-Cruz, PE, Frisbee-Hume, S, Allo, JA, Williams, JL & Cohen, MZ 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, vol. 31, no. 19, pp. 2421-2427. https://doi.org/10.1200/JCO.2012.45.3696
Bruera, Eduardo ; Yennurajalingam, Sriram ; Palmer, J. Lynn ; Perez-Cruz, Pedro E. ; Frisbee-Hume, Susan ; Allo, Julio A. ; Williams, Janet L. ; Cohen, Marlene Z. / Methylphenidate and/or a nursing telephone intervention for fatigue in patients with advanced cancer : A randomized, placebo-controlled, phase II trial. In: Journal of Clinical Oncology. 2013 ; Vol. 31, No. 19. pp. 2421-2427.
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abstract = "Purpose: 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. Patients and 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). Conclusion: MP and NTI alone or combined were not superior to placebo in improving CRF.",
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AU - Palmer, J. Lynn

AU - Perez-Cruz, Pedro E.

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AU - Allo, Julio A.

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