This study is being done to test whether bright light therapy can be used to synchronize patients' circadian rhythms and allow ICB (immune-checkpoint blockade) therapy to be administered at a time in the circadian rhythm that optimizes clinical outcomes. This trial will test the feasibility of delivering bright light therapy (BLT) to patients undergoing ICB therapy.
This trial asks participants to spend 60 minutes every morning receiving daily bright light therapy for at least 7 days prior to starting Immune Checkpoint blockade-containing regimens (e.g. anti-PD-1 and/or anti-CTLA-4 alone or in combination with chemotherapy). The bright light therapy will be delivered via the Circadian OS iPad application.
There is evidence that a person's circadian rhythm can affect the response to immunotherapy. The circadian rhythm is a natural, internal process that regulates the sleep-wake cycle. Many patients with cancer have disrupted circadian rhythms and it's possible that disrupted circadian rhythms decrease the likelihood of responding to immunotherapy.
The idea is to use bright light therapy, delivered via the Circadian OS iPad application, for an hour in the morning to synchronize your circadian rhythm for a week before your planned immunotherapy. The investigators hope that this will increase the likelihood of a response to immunotherapy, however in this study, the investigators are mainly concerned with whether the bright light therapy is tolerable to patients.
Age ≥18 years.
Histologically confirmed diagnosis of advanced, unresectable melanoma or NSCLC.
Presence of measurable tumor burden.
Scheduled to receive first-line cancer-directed therapy with an immune checkpoint blockade-containing regimen, as monotherapy or combination (e.g. pembrolizumab, ipilimumab + nivolumab, ICB + chemotherapy).
Previous exposure to immune checkpoint blockade.
Pregnant or breastfeeding.
Use of melatonin or pharmacologic sleep aids (e.g., zolpidem, trazodone, benzodiazepines) within 14 days prior to enrollment.
Diagnosis of bipolar disorder or history of mania or hypomania.
Single group
Bright Light Therapy
DeviceBright light therapy (BLT) will be delivered via the Circadian OS iPad application in patients with melanoma and NSCLC receiving first-line ICB-containing regimens (e.g. anti-PD-1 and/or anti-CTLA-4 alone or in combination with chemotherapy). CS is a unit designed to model melatonin suppression in order to measure how effective a light source is at stimulating the body's circadian system, based on light intensity, duration, and angle of delivery. CS will be delivered through the Circadian OS application. 60 minutes of BLT for \>7 days was chosen as an appropriate duration based on prior studies. With this stimulus, the goal is to entrain patients' circadian rhythm phase and amplitude to deliver ICB at peak immune function.
Proportion of participants who completed ≥70% BLT sessions, with a minimum of 7 consecutive days of monitoring.
The intervention will be considered feasible if ≥70% of patients achieve ≥70% adherence to the prescribed BLT sessions. Adherence will be automatically recorded via the Circadian OS iPad application using device-based monitoring of screen-on duration and light exposure data.
Number of Participants with Adverse Events (AEs)
This will include adverse events, serious adverse events, and unanticipated adverse device effects.
Proportion of Participants with Adverse Events (AEs)
This will include adverse events, serious adverse events, and unanticipated adverse device effects.
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Weill Medical College of Cornell University
Lead sponsor
Circadian OS, Inc
Collaborator
