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. 2018 Sep 10;18(1):880.
doi: 10.1186/s12885-018-4746-2.

Light therapy as a treatment of cancer-related fatigue in (non-)Hodgkin lymphoma survivors (SPARKLE trial): study protocol of a multicenter randomized controlled trial

Daniëlle E J Starreveld  1 , Laurien A Daniels  2 , Heiddis B Valdimarsdottir  3 , William H Redd  3 , Jessie L de Geus  1 , Sonia Ancoli-Israel  4 , Susan Lutgendorf  5 , Catharina M Korse  6 , Jacobien M Kieffer  1 , Flora E van Leeuwen  1 , Eveline M A Bleiker  7   8
Affiliations

Light therapy as a treatment of cancer-related fatigue in (non-)Hodgkin lymphoma survivors (SPARKLE trial): study protocol of a multicenter randomized controlled trial

Daniëlle E J Starreveld et al. BMC Cancer. .

Abstract

Background: Cancer related fatigue (CRF) is one of the most prevalent and distressing long-term complaints reported by (non-) Hodgkin survivors. To date there has been no standard treatment for CRF in this population. A novel and promising approach to treat CRF is exposure to bright white light therapy. Yet, large scale randomized controlled trials testing its efficacy in these patients and research on potential mechanisms is lacking. The objective of the current study is to investigate the efficacy of light therapy as a treatment for CRF and to explore potential mechanisms.

Methods/design: In a multicenter, randomized controlled trial we are evaluating the efficacy of two intensities of light therapy in reducing CRF complaints and restrictions caused by CRF in survivors of Hodgkin lymphoma or diffuse large B-cell lymphoma. Secondary outcomes include sleep quality, depression, anxiety, quality of life, cognitive complaints, cancer worries, fatigue catastrophizing, self-efficacy to handle fatigue, biological circadian rhythms of melatonin, cortisol and activity, and biomarkers of inflammation. We will recruit 128 survivors, with fatigue complaints, from academic and general hospitals. Survivors are randomized to either an intervention (exposure to bright white light) or a comparison group (exposure to dim white light). The longitudinal design includes four measurement points at baseline (T0), post-intervention at 3.5 weeks (T1), 3 months post-intervention (T2) and 9 months post-intervention (T3). Each measurement point includes self-reported questionnaires and actigraphy (10 days). T0 and T1 measurements also include collection of blood and saliva samples.

Discussion: Light therapy has the potential to be an effective treatment for CRF in cancer survivors. This study will provide insights on its efficacy and potential mechanisms. If proven to be effective, light therapy will provide an easy to deliver, low-cost and low-burden intervention, introducing a new era in the treatment of CRF.

Trial registration: The study is registered at ClinicalTrials.gov on August 8th 2017( NCT03242902 ).

Keywords: Cancer related fatigue; Circadian rhythms; Hematology; Light therapy; Randomized controlled trial; Sleep quality.

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Conflict of interest statement

Ethics approval and consent to participate

This study (NL 61017.031.17) has received ethical approval from the Institutional Review Board of The Netherlands Cancer Institute (METC-AVL), reference number M17SPA) on May 9th 2017 as a multi-center study. Amendments are changes made to the research after approval by the accredited METC has been given. All amendments will be notified to the METC that gave approval.

Participating hospitals are Admiraal de Ruyter hospital (Goes), Albert Schweitzer hospital (Dordrecht), Erasmus Medical Center (Rotterdam), Haga Hospital (The Hague), Leiden University Medical Center (Leiden), Radboud University Medical Center (Nijmegen), The Netherlands Cancer Institute (Amsterdam), University Medical Center Utrecht (Utrecht), VU University Medical Center (Amsterdam).

A written informed consent is obtained from all participants upon participation.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Overview of the trial design
Fig. 2
Fig. 2
Overview of study procedure
See this image and copyright information in PMC

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