To Decrease Fatigue With Light Therapy
Condition: Hodgkin Lymphoma; Diffuse Large B Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse; Fatigue
Study type: Interventional
Phase: Phase 3

Summary: 
      Cancer related fatigue (CRF) is one of the most prevalent and distressing long-term
      complaints reported by (non-) Hodgkin survivors. The SPARKLE study will test the efficacy of
      two intensities of light therapy on cancer related fatigue. Additionally, it explores
      possible working mechanisms of light therapy on CRF including improvements in sleep quality,
      psychosocial variables (depression, anxiety, cognitive complaints, and quality of life), and
      changes in biological circadian rhythms.
    

Detailed description: 
      Rationale: Cancer related fatigue (CRF) is one of the most prevalent and distressing
      long-term complaints reported by (non-)Hodgkin survivors. So far, there is no standard
      treatment. Some non-pharmacological interventions have shown large effects but show
      limitations as well, e.g. they are labor intensive. A novel and promising treatment for CRF
      is exposure to bright white light (BWL) therapy. This low-cost intervention is easy to
      deliver and has a low burden for professionals as well as for patients.

      Objective: To examine the efficacy of BWL therapy as an intervention for CRF. As a secondary
      aim, this study will explore possible working mechanisms including changes in sleep quality,
      psychological variables, biological circadian rhythms, sleep-wake cycles, inflammation
      markers and genotype.

      Study design: A multicenter randomized controlled trial will invite participants and allocate
      them to either a light intensity 1 condition (n=80) or a light intensity 2 condition (n=80).
      The longitudinal design will include four measurement points: baseline, mid-intervention,
      post-intervention, and at 3 and 9 months follow-up.

      Study population: Hodgkin and diffuse large B-cell lymphoma (DLBCL) survivors fulfilling the
      clinical criteria of CRF and a survivorship of ≥ 3 years will be invited. Fatigue should not
      be attributable to a clear somatic cause or treatment for secondary cancer in the past year.
      Moreover, 25 Hodgkin survivors without CRF will be recruited to explore the association
      between circadian rhythms and CRF.

      Intervention: The light intervention includes exposure to light for 30 minutes within the
      first half hour after awakening during 3,5 weeks.

      Main study parameters/endpoints: The main study parameter in this study is the change in CRF
      from baseline to post-intervention and at 3 and 9 months follow-up. This will be assessed
      with the Multidimensional Fatigue Inventory.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: Participation in this study includes completion of a light intervention for 3,5
      weeks (30 min each day) and 2 visits (1h) to the treating hospital pre- and
      post-intervention. The visits aim to provide instructions and equipment and to collect two
      blood samples. Additionally, 5 saliva samples will be collected by the participant at home
      pre- and post-intervention. Moreover, participants complete questionnaires (30 min, 4 times)
      and wear an accelerometer (10d, 4 times and during light therapy) to objectively measure
      sleep quality and activity. Risks of the light intervention are limited, although there are
      few known reports of agitation, headache and nausea during the first days of light exposure.
      Benefits are the use of an easy to administer treatment for one of the most distressing
      symptoms that participants report.
    

Intervention name(s): Light therapy intensity 1; Light therapy intensity 2
Intervention type(s): Device; Device
Intervention description(s): Exposure to white light (10.000 lux) in the morning; Exposure to white light (10-20 lux) in the morning
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: light therapy; cancer related fatigue; sleep quality; biological rhythms