Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066, CX, Amsterdam, The Netherlands.
Department of Radiotherapy, Leiden University Medical Center, Albinusdreef 2, 2333, ZA, Leiden, the Netherlands.
BMC Cancer. 2018 Sep 10;18(1):880. doi: 10.1186/s12885-018-4746-2.
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.
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.
The study is registered at ClinicalTrials.gov on August 8th 2017( NCT03242902 ).
癌症相关疲劳（CRF）是（非）霍奇金幸存者报告的最常见和最令人痛苦的长期抱怨之一。迄今为止，针对该人群的 CRF 尚无标准治疗方法。一种新颖且有前途的治疗 CRF 的方法是暴露于明亮的白光疗法。然而，缺乏在这些患者中测试其疗效的大规模随机对照试验和对潜在机制的研究。本研究的目的是调查光疗法作为治疗 CRF 的疗效，并探讨潜在的机制。
方法/设计：在一项多中心、随机对照试验中，我们正在评估两种强度的光疗在减轻霍奇金淋巴瘤或弥漫性大 B 细胞淋巴瘤幸存者的 CRF 投诉和由 CRF 引起的限制方面的疗效。次要结局包括睡眠质量、抑郁、焦虑、生活质量、认知投诉、癌症担忧、疲劳灾难化、处理疲劳的自我效能、褪黑素、皮质醇和活动的生物昼夜节律以及炎症生物标志物。我们将从学术和综合医院招募 128 名有疲劳投诉的幸存者。幸存者随机分为干预组（暴露于明亮的白光下）或对照组（暴露于昏暗的白光下）。纵向设计包括基线（T0）时的四个测量点、3.5 周后的干预后（T1）、3 个月后的干预后（T2）和 9 个月后的干预后（T3）。每个测量点包括自我报告的问卷和活动记录仪（10 天）。T0 和 T1 测量还包括血液和唾液样本的采集。
光疗法有可能成为癌症幸存者 CRF 的有效治疗方法。本研究将提供其疗效和潜在机制的见解。如果被证明有效，光疗法将提供一种易于实施、低成本和低负担的干预措施，开创 CRF 治疗的新纪元。
该研究于 2017 年 8 月 8 日在 ClinicalTrials.gov 注册（NCT03242902）。
