Recruiting

Bright Light Therapy

Sponsor:

Weill Medical College of Cornell University

Code:

NCT07661966

Conditions

Melanoma (Skin Cancer)

NSCLC (Non-small Cell Lung Cancer)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bright Light Therapy

Study Details

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.

Conditions

Melanoma (Skin Cancer)

NSCLC (Non-small Cell Lung Cancer)

Study ID

NCT07661966

Start date

Oct 3, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Single-arm: adherence to 60 mins of daily Bright Light Therapy for >7 days prior to ICB initiation

Interventions

Bright 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.

Primary outcome measure

  • Proportion of participants who completed ≥70% BLT sessions, with a minimum of 7 consecutive days of monitoring. [ Time Frame: Baseline through the day prior to Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks). ]

Central Contacts and Locations

Central contacts

June Greenberg, BSN, RN, OCN, CCRP, CCRC

212-746-2651jdg2002@med.cornell.edu

Daniella Topol, RN

dat7032@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

Contacts

June Greenberg

(212)-746-2651jdg2002@med.cornell.edu

Daniella Topol Topol

dat7032@med.cornell.edu

Principal Investigator:

Paul Chapman, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Keywords

  • IIT BLT
  • Bright Light Therapy
  • Circadian
  • Circadian Rhythm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.