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| Name | Class |
|---|---|
| Circadian OS, Inc | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm: adherence to 60 mins of daily Bright Light Therapy for >7 days prior to ICB initiation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bright Light Therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through the day prior to Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | This will include adverse events, serious adverse events, and unanticipated adverse device effects. | Baseline through first Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks). |
| Proportion of Participants with Adverse Events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| June Greenberg, BSN, RN, OCN, CCRP, CCRC | Contact | 212-746-2651 | jdg2002@med.cornell.edu | |
| Daniella Topol, RN | Contact | dat7032@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Paul Chapman, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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This will include adverse events, serious adverse events, and unanticipated adverse device effects. |
| Baseline through first Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks). |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D014467 | Ultraviolet Therapy |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
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