To Decrease Fatigue With Light Therapy

Hodgkin Lymphoma Clinical Trial

— SPARKLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242902
• Other study ID #: NL61017.031.17
• Status: Completed
• Phase: Phase 3
• Start date: September 20, 2017
• Est. completion date: August 11, 2020

Study information

• Verified date: August 2020
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: August 11, 2020
• Est. primary completion date: November 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Fatigue
• Hodgkin Lymphoma
• Lymphoma
• Lymphoma, Large B-Cell, Diffuse

Intervention

Device:
• Light therapy intensity 1
Exposure to white light (10.000 lux) in the morning
• Light therapy intensity 2
Exposure to white light (10-20 lux) in the morning

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institute	Amsterdam	Noord-Holland
Netherlands	VUmc	Amsterdam	Noord-Holland
Netherlands	Haga ziekenhuis	Den Haag
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht
Netherlands	Admiraal de Ruyter ziekenhuis	Goes
Netherlands	Leids Universitair Medisch Centrum	Leiden	Zuid-Holland
Netherlands	Radboudumc	Nijmegen	Gelderland
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	Dutch Cancer Society

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer related fatigue	Fatigue is assessed with the Multidimensional Fatigue Inventory	Change from baseline fatigue at end of 3,5 weeks light therapy
Primary	Cancer related fatigue	Fatigue is assessed with the Multidimensional Fatigue	Change from baseline fatigue at 3 months after light therapy
Primary	Cancer related fatigue	Fatigue is assessed with the Multidimensional Fatigue	Change from baseline fatigue at 9 months after light therapy
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Depression	Depression is assessed with the Center for Epidemiological Studies - depression scale	Change from baseline depression at end of 3,5 weeks light therapy
Secondary	Depression	Depression is assessed with the Center for Epidemiological Studies - depression scale	Change from baseline depression at 3 months after light therapy
Secondary	Depression	Depression is assessed with the Center for Epidemiological Studies - depression scale	Change from baseline depression at 9 months after light therapy
Secondary	Anxiety	Anxiety is assessed with the State Trait Anxiety Inventory-6 items	Change from baseline anxiety at end of 3,5 weeks light therapy
Secondary	Anxiety	Anxiety is assessed with the State Trait Anxiety Inventory-6 items	Change from baseline anxiety at 3 months after light therapy
Secondary	Anxiety	Anxiety is assessed with the State Trait Anxiety Inventory-6 items	Change from baseline anxiety at 9 months after light therapy
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cancer worries	Cancer worries is assessed with the Cancer Worry scale	Change from baseline cancer worries at end of 3,5 weeks light therapy
Secondary	Cancer worries	Cancer worries is assessed with the Cancer Worry scale	Change from baseline cancer worries at 3 months after light therapy
Secondary	Cancer worries	Cancer worries is assessed with the Cancer Worry scale	Change from baseline cancer worries at 9 months after light therapy
Secondary	Fatigue catastrophizing	Fatigue catastrophizing is assessed with the Fatigue catastrophizing scale	Baseline
Secondary	Self-efficacy	Self-efficacy is assessed with the Self-efficacy Scale 28	Baseline
Secondary	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
Secondary	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