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Original research
Improved cancer-related fatigue in a randomised clinical trial: methylphenidate no better than placebo
  1. Carlos Centeno1,2,3,
  2. Rocío Rojí1,3,
  3. Maria Angustias Portela1,4,
  4. Ana De Santiago5,
  5. Miguel Angel Cuervo6,
  6. Daniel Ramos7,
  7. Alvaro Gandara4,8,
  8. Esteban Salgado9,
  9. Bruno Gagnon10 and
  10. Alvaro Sanz11
  1. 1 Palliative Medicine, University of Navarra Clinic, Pamplona, Spain
  2. 2 Culture and Society Institute, ATLANTES Project, University of Navarra, Pamplona, Spain
  3. 3 IdiSNA, Pamplona, Navarra, Spain
  4. 4 Palliative Care Unit, Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain
  5. 5 Palliative Medicine, Foundation Vianorte-Laguna, Madrid, Spain
  6. 6 Palliative Care Team, University Hospital Complex Badajoz, Badajoz, Spain
  7. 7 Palliative Care Team, Rio Hortega University Hospital, Valladolid, Spain
  8. 8 Palliative Medicine, Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain
  9. 9 Oncology, Navarre Hospital Complex, Pamplona, Spain
  10. 10 McGill University, Montreal, Québec, Canada
  11. 11 Medical Oncology, Rio Hortega University Hospital, Valladolid, Spain
  1. Correspondence to Dr Rocío Rojí, Palliative Medicine, University of Navarra Clinic, 31008 Pamplona, Navarra, Spain; rrojbuq{at}unav.es

Abstract

Introduction Methylphenidate is a psychostimulant drug used to treat fatigue in patients with advanced cancer, for which there is no gold standard of treatment.

Objective To explore the efficacy of methylphenidate in the relief of fatigue in patients with advanced cancer.

Materials and methods A randomised double-blind placebo-controlled multicentre clinical trial, stratified according to the intensity of fatigue. The treatment was considered effective if the improvement in mean fatigue intensity between baseline values and day 6 was significantly higher in the methylphenidate group than in the placebo group. The responses were measured using the Edmonton Symptoms Assessment System (ESAS) and the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scales.

Results 35 patients received placebo and 42 patients received methylphenidate. The populations of both groups were homogeneous. Patients receiving methylphenidate did not exhibit statistically significant improvement of fatigue in comparison to patients receiving placebo (p=0.52). The mean improvement of fatigue (ESAS) on day 6 was −1.9 (±2.5) in the placebo group, and −2.3 (±2.6) in the methylphenidate group (p=0.52). The results obtained with the FACT-F were congruent with those obtained by the ESAS. The responses in patients with severe fatigue were −2.4 (±2.9) in the placebo group and −3.4 (±2.5) in the methylphenidate group; the difference was not statistically significant (p=0.3).

Conclusion Methylphenidate was not more efficient than placebo to treat cancer-related fatigue. Fatigue improved significantly after 3 days of treatment and was stabilised on day 6, both with placebo and methylphenidate. The side effects of methylphenidate were mild and infrequent.

Trial registration number EudraCT Registry (2008-002171-27).

  • fatigue
  • cancer
  • supportive care
  • pharmacology

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/bmjspcare-2020-002454

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • Twitter @rociorojib

    • Contributors CC, MAP and AS contributed especially to the design of the essay. CC, RR, MAP, ADS, MAC, DR, AG, ES and AS contributed to data collection. CC, AS and RR contributed to the analysis, interpretation of the results and writing of the article. All authors have agreed to the final version and declare that they have no conflict of interest.

    • Funding The preparation of the study medication and placebo, the logistics management of the trial medication, the insurance policy, the monitoring, and other expenses (travel, translation, unforeseen events) were budgeted. Resources were obtained from the Research Plan of the University of Navarre (PIUNA 2009/2010), McGill University, Montreal, Canada, and the Government of Navarre (2009 Projects for Health).

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.