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Open Access Study protocol

Using aggregated single patient (N-of-1) trials to determine the effectiveness of psychostimulants to reduce fatigue in advanced cancer patients: a rationale and protocol

Hugh EJ Senior1*, Geoffrey K Mitchell1, Jane Nikles1, Sue-Ann Carmont1, Philip J Schluter23, David C Currow4, Rohan Vora5, Michael J Yelland6, Meera Agar4, Phillip D Good78 and Janet R Hardy8

Author Affiliations

1 Discipline of General Practice, The University of Queensland, Brisbane, Queensland, Australia

2 School of Health Sciences, University of Canterbury, Christchurch, New Zealand

3 School of Nursing and Midwifery, The University of Queensland, Brisbane, Queensland, Australia

4 Discipline of Palliative and Supportive Services, Flinders University, Adelaide, South Australia, Australia

5 Department of Palliative Care, Gold Coast Hospital, Gold Coast, Queensland, Australia

6 School of Medicine, Griffith University, Gold Coast, Queensland, Australia

7 Department of Palliative Care, St. Vincent‘s Hospital, Brisbane, Queensland, Australia

8 Mater Health Services, Department of Palliative Care, Brisbane, Queensland, Australia

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BMC Palliative Care 2013, 12:17  doi:10.1186/1472-684X-12-17

Published: 23 April 2013

Abstract

Background

It is estimated that 29% of deaths in Australia are caused by malignant disease each year and can be expected to increase with population ageing. In advanced cancer, the prevalence of fatigue is high at 70–90%, and can be related to the disease and/or the treatment. The negative impact of fatigue on function (physical, mental, social and spiritual) and quality of life is substantial for many palliative patients as well as their families/carers.

Method/design

This paper describes the design of single patient trials (n-of-1 s or SPTs) of a psychostimulant, methylphenidate hydrochloride (MPH) (5 mg bd), compared to placebo as a treatment for fatigue, with a population estimate of the benefit by the aggregation of multiple SPTs. Forty patients who have advanced cancer will be enrolled through specialist palliative care services in Australia. Patients will complete up to 3 cycles of treatment. Each cycle is 6 days long and has 3 days treatment and 3 days placebo. The order of treatment and placebo is randomly allocated for each cycle. The primary outcome is a reduction in fatigue severity as measured by the Functional Assessment of Cancer Therapy-fatigue subscale (FACIT-F). Secondary outcomes include adverse events, quality of life, additional fatigue assessments, depression and Australian Karnovsky Performance Scale.

Discussion

This study will provide high-level evidence using a novel methodological approach about the effectiveness of psychostimulants for cancer-related fatigue. If effective, the findings will guide clinical practice in reducing this prevalent condition to improve function and quality of life.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN12609000794202

Keywords:
Fatigue; Cancer; Methylphenidate hydrochloride; N-of-1 trial; Single patient trial; Palliative