Melanoma (Skin Cancer), NSCLC (Non-small Cell Lung Cancer)
Conditions
Keywords
IIT BLT, Bright Light Therapy, Circadian, Circadian Rhythm
Brief summary
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.
Detailed description
This is a pilot study evaluating the feasibility, safety, and biological effects of bright light therapy (BLT) delivered via the Circadian OS iPad application in patients with melanoma and non-small cell lung cancer (NSCLC) receiving first-line immune checkpoint blockade (ICB)-containing regimens. This is a single-arm feasibility study of adherence to 60 minutes of daily BLT for \>7 days prior to ICB initiation. The investigators aims to enroll patients with measurable tumor burden who plan to receive first line ICB-containing regimens (e.g. anti-PD-1 and/or anti-CTLA-4 alone or in combination with chemotherapy).
Interventions
DEVICEBright Light Therapy
Bright 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.
Sponsors
Weill Medical College of Cornell University
Circadian OS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years. 2. Histologically confirmed diagnosis of advanced, unresectable melanoma or NSCLC. 3. Presence of measurable tumor burden. 4. 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). 5. ECOG performance status 0-2. 6. Able to provide informed consent. 7. Access to reliable internet connection via WiFi or personal hotspot
Exclusion criteria
1. Previous exposure to immune checkpoint blockade. 2. Pregnant or breastfeeding. 3. Use of melatonin or pharmacologic sleep aids (e.g., zolpidem, trazodone, benzodiazepines) within 14 days prior to enrollment. 4. Diagnosis of bipolar disorder or history of mania or hypomania. 5. Active psychosis, suicidal ideation, or recent psychiatric hospitalization (\<3 months). 6. Poorly controlled seizures. 7. Chronotype classified as extremely early or extremely late, based on the Munich Chronotype Questionnaire (MSFsc \< 2:00 or \> 5:00). 8. Night shift work within the past 30 days or expected during the intervention. 9. Travel across ≥2 time zones within the past 14 days. 10. Diagnosed or suspected untreated moderate to severe obstructive sleep apnea. 11. Migraine with photophobia. 12. Presence of ocular or photosensitivity conditions affecting vision (i.e. advanced bilateral cataracts not yet operated, advanced glaucoma with substantial visual field loss, optic nerve disease, ocular surgery within the past 3 months with unresolved visual symptoms, color blindness).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who completed ≥70% BLT sessions, with a minimum of 7 consecutive days of monitoring. | Baseline through the day prior to Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Baseline through first Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks). | This will include adverse events, serious adverse events, and unanticipated adverse device effects. |
| Proportion of Participants with Adverse Events (AEs) | Baseline through first Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks). | This will include adverse events, serious adverse events, and unanticipated adverse device effects. |
Countries
United States
Contacts
CONTACTJune Greenberg, BSN, RN, OCN, CCRP, CCRC
CONTACTDaniella Topol, RN
PRINCIPAL_INVESTIGATORPaul Chapman, MD
Weill Medical College of Cornell University
Outcome results
None listed