This clinical trial evaluates systematic bright light exposure for improving fatigue and thinking efficiency among pediatric brain tumor survivors. Children who are diagnosed and treated for a brain tumor are at risk for cognitive (thinking) problems, including inattention and slow speed of processing information. Fatigue also commonly affects survivors of pediatric brain tumors, and it impacts a number of cognitive skills. Bright light exposure affects a number of biological functions, including sleep rhythms, alertness, attention, and cognition. Systematic bright light exposure has been shown to improve sleep and reduce fatigue among adolescents and young adults undergoing treatment for solid tumor as well as adult cancer survivors, but it is not known how bright light exposure affects pediatric brain tumor patients. Bright light exposure may be effective at improving fatigue and cognition in pediatric brain tumor survivors.
Additional locations may be listed on ClinicalTrials.gov for NCT05340881.
Locations matching your search criteria
United States
Texas
Houston
Texas Children's HospitalStatus: Active
Contact: Kimberly Raghubar
Phone: 832-822-3713
PRIMARY OBJECTIVES:
I. Evaluate feasibility and adherence in a study of systematic light exposure used to improve fatigue and cognitive efficiency in survivors of pediatric brain tumor, including rates of enrollment, attrition, adherence, and acceptability.
II. Estimate the magnitude of change in fatigue associated with systematic bright light exposure.
III. Estimate the magnitude of change in cognitive efficiency in survivors of pediatric brain tumor.
EXPLORATORY OBJECTIVE:
I. Examine the effects of bright light exposure on targeted mechanisms of sleep-wake cycles, circadian rhythmicity, hypothalamic-pituitary axis function, and mood.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo bright light exposure using the Luminette glasses upon waking for 10 minutes on days 1 and 2, 20 minutes on days 3 and 4, and then 30 minutes beginning on day 5 up to 6 weeks. Patients also wear an actigraph throughout the trial.
ARM II: Patients undergo dim light exposure using the Luminette glasses upon waking for 10 minutes on days 1 and 2, 20 minutes on days 3 and 4, and then 30 minutes beginning on day 5 up to 6 weeks. Patients also wear an actigraph throughout the trial.
After completion of study intervention, patients are followed up at week 8.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorKimberly Raghubar
