To Decrease Fatigue With Light Therapy (SPARKLE)

Improving Sleep Quality, Psychosocial Functioning, and Cancer Related Fatigue With Light Therapy

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.

Study Overview

• Status: Completed
• Conditions: Hodgkin Lymphoma; Diffuse Large B Cell Lymphoma
• Intervention / Treatment: Device: Light therapy intensity 1; Device: Light therapy intensity 2

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.

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Phase 3

Contacts and Locations

Study Locations

• Netherlands
  • Den Haag, Netherlands, 2545 CH
    • Haga ziekenhuis
  • Dordrecht, Netherlands, 3300 AK
    • Albert Schweitzer Ziekenhuis
  • Goes, Netherlands, 3318 AT
    • Admiraal de Ruyter Ziekenhuis
  • Utrecht, Netherlands, 2508 GA
    • Universitair Medisch Centrum Utrecht
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • Radboudumc
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1066 CX
      • Netherlands Cancer Institute
    • Amsterdam, Noord-Holland, Netherlands, 1081 HV
      • VUmc
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands, 2300 RC
      • Leids Universitair Medisch Centrum
    • Rotterdam, Zuid-Holland, Netherlands, 3000 CA
      • Erasmus MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A history of Hodgkin or DLBCL with a survivorship of ≥ 3 years.
• The presence of moderate to severe fatigue symptoms since diagnosis of or treatment for Hodgkin lymphoma or DLBCL.

Exclusion Criteria:

• Fatigue is explained by a somatic factor as defined in the guidelines of chronic fatigue syndrome of the Dutch internists association (NIV). When a somatic cause for fatigue is resolved by stable medication use ≥ 6 months, patients can be included in the current trial.
• Pregnancy (until 3 months postnatal) or women who provide breast feeding
• Extensive surgical operations in the past 3 months.
• Current diagnosis of a psychiatric disorder (e.g. personality disorders, psychosis, bipolar disorder) which would limit participation.
• Diagnosis of and treatment for a secondary malignancy in the past 12 months.
• Presence of photophobia (abnormal intolerance to visual perception of light) or another eye disease that shows symptoms of photophobia (e.g. aniridia, retinitis pigmentosa, glaucoma).
• Current or previous use of light therapy for more than 1 week.
• Current employment in shift work.
• Insufficient knowledge of the Dutch language.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Light intensity 1; The light intervention includes exposure to white light (10.000 lux) at a distance of 45 cm for 30 minutes within the first half hour after awakening during 3 weeks and 4 days. This can be done while engaged in other activities, for example reading the newspaper or eating breakfast.	Device: Light therapy intensity 1; Exposure to white light (10.000 lux) in the morning
Experimental: Light intensity 2; The light intervention includes exposure to white light (10-20 lux) at a distance of 45 cm for 30 minutes within the first half hour after awakening during 3 weeks and 4 days. This can be done while engaged in other activities, for example reading the newspaper or eating breakfast.	Device: Light therapy intensity 2; Exposure to white light (10-20 lux) in the morning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer related fatigue	Fatigue is assessed with the Multidimensional Fatigue Inventory	Change from baseline fatigue at end of 3,5 weeks light therapy
Cancer related fatigue	Fatigue is assessed with the Multidimensional Fatigue	Change from baseline fatigue at 3 months after light therapy
Cancer related fatigue	Fatigue is assessed with the Multidimensional Fatigue	Change from baseline fatigue at 9 months after light therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective sleep quality	Subjective sleep quality is assessed with the Pittsburg Sleep Quality Index	Change from baseline subjective sleep quality at end of 3,5 weeks light therapy
Subjective sleep quality	Subjective sleep quality is assessed with the Pittsburg Sleep Quality Index	Change from baseline subjective sleep quality at 3 months after light therapy
Subjective sleep quality	Subjective sleep quality is assessed with the Pittsburg Sleep Quality Index	Change from baseline subjective sleep quality at 9 months after light therapy
Objective sleep quality	Objective sleep quality data is assessed by wearing an accelerometer for 10 days	Change from baseline objective sleep quality at end of 3,5 weeks light therapy
Objective sleep quality	Objective sleep quality data is assessed by wearing an accelerometer for 10 days	Change from baseline objective sleep quality at 3 months after light therapy
Objective sleep quality	Objective sleep quality data is assessed by wearing an accelerometer for 10 days	Change from baseline objective sleep quality at 9 months after light therapy
Depression	Depression is assessed with the Center for Epidemiological Studies - depression scale	Change from baseline depression at end of 3,5 weeks light therapy
Depression	Depression is assessed with the Center for Epidemiological Studies - depression scale	Change from baseline depression at 3 months after light therapy
Depression	Depression is assessed with the Center for Epidemiological Studies - depression scale	Change from baseline depression at 9 months after light therapy
Anxiety	Anxiety is assessed with the State Trait Anxiety Inventory-6 items	Change from baseline anxiety at end of 3,5 weeks light therapy
Anxiety	Anxiety is assessed with the State Trait Anxiety Inventory-6 items	Change from baseline anxiety at 3 months after light therapy
Anxiety	Anxiety is assessed with the State Trait Anxiety Inventory-6 items	Change from baseline anxiety at 9 months after light therapy
Quality of life	Quality of life is assessed with the Medical Outcome studies short form (SF-36)	Change from baseline quality of life at end of 3,5 weeks light therapy
Quality of life	Quality of life is assessed with the Medical Outcome studies short form (SF-36)	Change from baseline quality of life at 3 months after light therapy
Quality of life	Quality of life is assessed with the Medical Outcome studies short form (SF-36)	Change from baseline quality of life at 9 months after light therapy
Subjective cognitive complaints	Subjective cognitive complaints assessed with the Medical Outcomes Studies Cognitive functioning.	Change from baseline subjective cognitive complaints at end of 3,5 weeks light therapy
Subjective cognitive complaints	Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory	Change from baseline subjective cognitive complaints at end of 3,5 weeks light therapy
Subjective cognitive complaints	Subjective cognitive complaints assessed with the Medical Outcomes Studies Cognitive functioning	Change from baseline subjective cognitive complaints at 3 months after light therapy
Subjective cognitive complaints	Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory	Change from baseline subjective cognitive complaints at 3 months after light therapy
Subjective cognitive complaints	Subjective cognitive complaints assessed with the Medical Outcomes Studies Cognitive functioning	Change from baseline subjective cognitive complaints at 9 months after light therapy
Subjective cognitive complaints	Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory	Change from baseline subjective cognitive complaints at 9 months after light therapy
Objective cognitive complaints - alertness and sustained attention	Objective cognitive complaints are assessed with the Psychomotor Vigilance Task.	Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy
Objective cognitive complaints - long-term memory	Objective cognitive complaints are assessed with the 15 words test.	Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy
Objective cognitive complaints - short-term memory	Objective cognitive complaints are assessed with the digit span task.	Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy
Cancer worries	Cancer worries is assessed with the Cancer Worry scale	Change from baseline cancer worries at end of 3,5 weeks light therapy
Cancer worries	Cancer worries is assessed with the Cancer Worry scale	Change from baseline cancer worries at 3 months after light therapy
Cancer worries	Cancer worries is assessed with the Cancer Worry scale	Change from baseline cancer worries at 9 months after light therapy
Fatigue catastrophizing	Fatigue catastrophizing is assessed with the Fatigue catastrophizing scale	Baseline
Self-efficacy	Self-efficacy is assessed with the Self-efficacy Scale 28	Baseline
Circadian rhythms of cortisol and melatonin	Circadian rhythms of cortisol and melatonin will be determined from saliva samples	Change from baseline circadian rhythms at end of 3,5 weeks light therapy
Biomarkers of inflammation and genotype	Biomarkers of inflammation (hsIL-6, sTNF-RII, IL-1RA, hsCRP, vitamin D) and genotype will be determined from blood samples	Change from baseline levels of biomarkers at end of 3,5 weeks light therapy

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Collaborators: Dutch Cancer Society
• Investigators: Principal Investigator: Eveline Bleiker, PhD, The Netherlands Cancer Institute; Principal Investigator: Flora van Leeuwen, Prof.dr.ir., The Netherlands Cancer Institute; Principal Investigator: Laurien Daniels, PhD, MD, Leiden University Medical Center

Publications and helpful links

General Publications

• Starreveld DEJ, Daniels LA, Valdimarsdottir HB, Redd WH, de Geus JL, Ancoli-Israel S, Lutgendorf S, Korse CM, Kieffer JM, van Leeuwen FE, Bleiker EMA. Light therapy as a treatment of cancer-related fatigue in (non-)Hodgkin lymphoma survivors (SPARKLE trial): study protocol of a multicenter randomized controlled trial. BMC Cancer. 2018 Sep 10;18(1):880. doi: 10.1186/s12885-018-4746-2.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2017
• Primary Completion (Actual): November 25, 2019
• Study Completion (Actual): August 11, 2020

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: cancer related fatigue; sleep quality; light therapy; biological rhythms
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Lymphoma, Large B-Cell, Diffuse; Fatigue
• Other Study ID Numbers: NL61017.031.17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No