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Bright Light Therapy in Patients With Melanoma or Non-small Cell Lung Cancer (NSCLC) Who Are Receiving First-Line Immune Checkpoint Blockade

A Pilot Trial of Bright Light Therapy in Patients Receiving First Line Immune Checkpoint Blockade

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether people with advanced melanoma or non-small cell lung cancer can tolerate bright light therapy before their first immune checkpoint treatment, which helps the immune system fight cancer. Participants use an iPad app for 60 minutes each morning for at least 7 days before treatment. The goal is to help set the body's sleep-wake clock so cancer treatment can be timed better.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • A tissue test shows advanced melanoma or non-small cell lung cancer that cannot be removed by surgery.
  • You have a tumor that can be measured.
  • You are scheduled for your first cancer treatment with an immune checkpoint drug, alone or with other drugs.
  • You can care for yourself and are out of bed or a chair for at least half of your waking hours.
  • You can understand the study and agree to take part.
  • You have reliable internet through WiFi or a personal hotspot.

Who can't join

  • You have had immune checkpoint treatment before, or you are pregnant or breastfeeding.
  • You used melatonin or sleep medicines within 14 days before joining.
  • You have bipolar disorder or a history of mania or hypomania (unusually high energy or mood). You have current psychosis (trouble knowing what is real), thoughts of suicide, or a mental health hospital stay within the past 3 months.
  • You have seizures that are not well controlled.
  • A sleep timing survey shows an extremely early or late body clock. You worked night shifts in the past 30 days or expect to during the study.
  • You traveled across 2 or more time zones in the past 14 days.
  • You have known or suspected moderate to severe untreated sleep apnea (breathing that stops and starts during sleep), or migraines with light sensitivity.
  • You have eye or light-sensitivity problems that affect vision, such as severe cataracts in both eyes, advanced glaucoma, optic nerve disease, color blindness, or eye surgery within 3 months with lasting vision symptoms.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

NY