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Hodgkin LymphomaPhase 3SPARKLENCT03242902

To Decrease Fatigue With Light Therapy

A Phase 3 study testing Light therapy intensity 1 and Light therapy intensity 2 in people with Hodgkin Lymphoma and Diffuse Large B Cell Lymphoma, run by The Netherlands Cancer Institute at 9 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Light therapy intensity 1 and Light therapy intensity 2
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
166 participants
Where
9 sitesNetherlands
Study dates
20 Sep 2017to 11 Aug 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 9Show fewer
  • Current or previous use of light therapy for more than 1 week.
  • Current employment in shift work.
  • Insufficient knowledge of the Dutch language.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Netherlands9 sites

  • Netherlands Cancer Institute

    Amsterdam, North Holland, 1066 CX

  • VUmc

    Amsterdam, North Holland, 1081 HV

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3300 AK

  • Admiraal de Ruyter ziekenhuis

    Goes, 3318 AT

  • Leids Universitair Medisch Centrum

    Leiden, South Holland, 2300 RC

  • Radboudumc

    Nijmegen, Gelderland, 6500 HB

  • Erasmus MC

    Rotterdam, South Holland, 3000 CA

  • Haga ziekenhuis

    The Hague, 2545 CH

  • Universitair Medisch Centrum Utrecht

    Utrecht, 2508 GA

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Being tested
Light therapy intensity 1, Light therapy intensity 2
Keywords
light therapy, cancer related fatigue, sleep quality, biological rhythms
Medical subject headings
Hodgkin Disease, Lymphoma, Large B-Cell, Diffuse, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Light therapy intensity 1Device

    Exposure to white light (10.000 lux) in the morning

  • Light therapy intensity 2Device

    Exposure to white light (10-20 lux) in the morning

Study groups in NCT03242902
Study groupRoleWhat they receive
Light intensity 1ExperimentalThe 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.
Receives: Device: Light therapy intensity 1
Light intensity 2ExperimentalThe 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.
Receives: Device: Light therapy intensity 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cancer related fatigue

    Fatigue is assessed with the Multidimensional Fatigue Inventory

    Measured: Change from baseline fatigue at end of 3,5 weeks light therapy

  2. Cancer related fatigue

    Fatigue is assessed with the Multidimensional Fatigue

    Measured: Change from baseline fatigue at 3 months after light therapy

  3. Cancer related fatigue

    Fatigue is assessed with the Multidimensional Fatigue

    Measured: Change from baseline fatigue at 9 months after light therapy

Secondary outcomes (31)

  1. Subjective sleep quality

    Subjective sleep quality is assessed with the Pittsburg Sleep Quality Index

    Measured: Change from baseline subjective sleep quality at end of 3,5 weeks light therapy

  2. Subjective sleep quality

    Subjective sleep quality is assessed with the Pittsburg Sleep Quality Index

    Measured: Change from baseline subjective sleep quality at 3 months after light therapy

  3. Subjective sleep quality

    Subjective sleep quality is assessed with the Pittsburg Sleep Quality Index

    Measured: Change from baseline subjective sleep quality at 9 months after light therapy

  4. Objective sleep quality

    Objective sleep quality data is assessed by wearing an accelerometer for 10 days

    Measured: Change from baseline objective sleep quality at end of 3,5 weeks light therapy

  5. Objective sleep quality

    Objective sleep quality data is assessed by wearing an accelerometer for 10 days

    Measured: Change from baseline objective sleep quality at 3 months after light therapy

  6. Objective sleep quality

    Objective sleep quality data is assessed by wearing an accelerometer for 10 days

    Measured: Change from baseline objective sleep quality at 9 months after light therapy

  7. Depression

    Depression is assessed with the Center for Epidemiological Studies - depression scale

    Measured: Change from baseline depression at end of 3,5 weeks light therapy

  8. Depression

    Depression is assessed with the Center for Epidemiological Studies - depression scale

    Measured: Change from baseline depression at 3 months after light therapy

  9. Depression

    Depression is assessed with the Center for Epidemiological Studies - depression scale

    Measured: Change from baseline depression at 9 months after light therapy

  10. Anxiety

    Anxiety is assessed with the State Trait Anxiety Inventory-6 items

    Measured: Change from baseline anxiety at end of 3,5 weeks light therapy

  11. Anxiety

    Anxiety is assessed with the State Trait Anxiety Inventory-6 items

    Measured: Change from baseline anxiety at 3 months after light therapy

  12. Anxiety

    Anxiety is assessed with the State Trait Anxiety Inventory-6 items

    Measured: Change from baseline anxiety at 9 months after light therapy

  13. Quality of life

    Quality of life is assessed with the Medical Outcome studies short form (SF-36)

    Measured: Change from baseline quality of life at end of 3,5 weeks light therapy

  14. Quality of life

    Quality of life is assessed with the Medical Outcome studies short form (SF-36)

    Measured: Change from baseline quality of life at 3 months after light therapy

  15. Quality of life

    Quality of life is assessed with the Medical Outcome studies short form (SF-36)

    Measured: Change from baseline quality of life at 9 months after light therapy

  16. Subjective cognitive complaints

    Subjective cognitive complaints assessed with the Medical Outcomes Studies Cognitive functioning.

    Measured: Change from baseline subjective cognitive complaints at end of 3,5 weeks light therapy

  17. Subjective cognitive complaints

    Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory

    Measured: Change from baseline subjective cognitive complaints at end of 3,5 weeks light therapy

  18. Subjective cognitive complaints

    Subjective cognitive complaints assessed with the Medical Outcomes Studies Cognitive functioning

    Measured: Change from baseline subjective cognitive complaints at 3 months after light therapy

  19. Subjective cognitive complaints

    Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory

    Measured: Change from baseline subjective cognitive complaints at 3 months after light therapy

  20. Subjective cognitive complaints

    Subjective cognitive complaints assessed with the Medical Outcomes Studies Cognitive functioning

    Measured: Change from baseline subjective cognitive complaints at 9 months after light therapy

  21. Subjective cognitive complaints

    Subjective cognitive complaints assessed with the MD Anderson Symptom Inventory

    Measured: Change from baseline subjective cognitive complaints at 9 months after light therapy

  22. Objective cognitive complaints - alertness and sustained attention

    Objective cognitive complaints are assessed with the Psychomotor Vigilance Task.

    Measured: Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy

  23. Objective cognitive complaints - long-term memory

    Objective cognitive complaints are assessed with the 15 words test.

    Measured: Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy

  24. Objective cognitive complaints - short-term memory

    Objective cognitive complaints are assessed with the digit span task.

    Measured: Change from baseline objective cognitive complaints at end of 3,5 weeks light therapy

  25. Cancer worries

    Cancer worries is assessed with the Cancer Worry scale

    Measured: Change from baseline cancer worries at end of 3,5 weeks light therapy

  26. Cancer worries

    Cancer worries is assessed with the Cancer Worry scale

    Measured: Change from baseline cancer worries at 3 months after light therapy

  27. Cancer worries

    Cancer worries is assessed with the Cancer Worry scale

    Measured: Change from baseline cancer worries at 9 months after light therapy

  28. Fatigue catastrophizing

    Fatigue catastrophizing is assessed with the Fatigue catastrophizing scale

    Measured: Baseline

  29. Self-efficacy

    Self-efficacy is assessed with the Self-efficacy Scale 28

    Measured: Baseline

  30. Circadian rhythms of cortisol and melatonin

    Circadian rhythms of cortisol and melatonin will be determined from saliva samples

    Measured: Change from baseline circadian rhythms at end of 3,5 weeks light therapy

  31. 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

    Measured: Change from baseline levels of biomarkers at end of 3,5 weeks light therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2017
  2. Study start20 Sep 2017
  3. Primary completion25 Nov 2019
  4. Study completion11 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
166 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03242902
Sponsor's protocol ID
NL61017.031.17
Acronym
SPARKLE
Status last verified
Aug 2020
First submitted
24 Jul 2017
Last updated
1 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 30200906

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Light therapy intensity 1 and Light therapy intensity 2 in people with Hodgkin Lymphoma and Diffuse Large B Cell Lymphoma, run by The Netherlands Cancer Institute at 9 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cancer related fatigue (time frame: Change from baseline fatigue at end of 3,5 weeks light therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03242902, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.

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