4.1 Article

The LITE study: Rationale and protocol for a randomized controlled trial of light therapy for cancer-related fatigue in cancer survivors

Journal

CONTEMPORARY CLINICAL TRIALS
Volume 49, Issue -, Pages 166-173

Publisher

ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2016.07.004

Keywords

Randomized controlled trial; Light therapy; Cancer-related fatigue; Cancer; Sleep; Mood disturbance

Funding

  1. Canadian Cancer Society Research Institute - Innovation grant [2012-701425]
  2. Alberta Cancer Foundation
  3. Lloyd & Florence Cooper Memorial Fund
  4. Killam Trust
  5. Alberta Innovates-Health Solutions

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Fatigue is a common and distressing symptom that can last for months or years in up to one-third of cancer survivors. Despite its prevalence, the nature and mechanisms of cancer-related fatigue are poorly understood and the available treatments may not provide sufficient relief. Fatigue has been identified as a significant contributor to decreased quality of life, making it an important target for intervention. One approach that may be a safe and inexpensive treatment is bright light therapy. Methods: This study is a 4-week blinded randomized controlled trial. Subjects will be men and women who meet criteria for cancer-related fatigue and have completed cancer treatment. Subjects will be randomly assigned to receive a Litebook treatment device that produces either bright white light (treatment) or dim red light (active control). The devices will be used daily for 30 min upon waking for a period of four weeks. The primary outcome, fatigue, will be measured with the Multidimensional Fatigue Symptom Inventory-SF. Secondary outcomes include mood disturbance, sleep quality, quality of life, diurnal cortisol, and inflammatory biomarkers. Fatigue assessments will be completed weekly and secondary outcomes will be assessed at pre- and post-intervention. Conclusions: The current research will examine the effect of light exposure on cancer-related fatigue and its potential psychological, behavioral, and biological mechanisms. If successful, this research would support the use of light therapy for the management of persistent fatigue in cancer survivors, expanding existing treatment options. It may also improve upon the current understanding of the mechanisms that underlie cancer-related fatigue. (C) 2016 Elsevier Inc. All rights reserved.

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