Status:
COMPLETED
To Decrease Fatigue With Light Therapy
Lead Sponsor:
The Netherlands Cancer Institute
Collaborating Sponsors:
Dutch Cancer Society
Conditions:
Hodgkin Lymphoma
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 ligh...
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-pharmaco...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2020
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT03242902
Start Date
September 20 2017
End Date
August 11 2020
Last Update
September 1 2020
Active Locations (9)
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1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6500 HB
2
Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands, 1066 CX
3
VUmc
Amsterdam, North Holland, Netherlands, 1081 HV
4
Leids Universitair Medisch Centrum
Leiden, South Holland, Netherlands, 2300 RC