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Clinical Trial
. 2013 Jul 1;31(19):2421-7.
doi: 10.1200/JCO.2012.45.3696. Epub 2013 May 20.

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

Eduardo Bruera  1 , Sriram Yennurajalingam, J Lynn Palmer, Pedro E Perez-Cruz, Susan Frisbee-Hume, Julio A Allo, Janet L Williams, Marlene Z Cohen
Affiliations
Clinical Trial

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

Eduardo Bruera et al. J Clin Oncol. .

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.

Trial registration: ClinicalTrials.gov NCT00424099.

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Conflict of interest statement

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Figures

Fig 1.
Fig 1.
CONSORT diagram. NTI, nursing telephone intervention.
See this image and copyright information in PMC

Comment in

References

    1. Yennurajalingam S, Bruera E. Palliative management of fatigue at the close of life: “It feels like my body is just worn out.”. JAMA. 2007;297:295–304. - PubMed
    1. Lawrence DP, Kupelnick B, Miller K, et al. Evidence report on the occurrence, assessment, and treatment of fatigue in cancer patients. J Natl Cancer Inst Monogr. 2004;2004:40–50. - PubMed
    1. Piper BF, Cella D. Cancer-related fatigue: Definitions and clinical subtypes. J Natl Compr Canc Netw. 2010;8:958–966. - PubMed
    1. Minton O, Richardson A, Sharpe M, et al. Drug therapy for the management of cancer-related fatigue. Cochrane Database Syst Rev. 2010;7:CD006704. - PMC - PubMed
    1. Minton O, Richardson A, Sharpe M, et al. Psychostimulants for the management of cancer-related fatigue: A systematic review and meta-analysis. J Pain Symptom Manage. 2011;41:761–767. - PubMed

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