Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin Cancer) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| NSCLC (Non-small Cell Lung Cancer) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bright Light Therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single-arm: adherence to 60 mins of daily Bright Light Therapy for >7 days prior to ICB initiation
- interventionNames
- Device: Bright Light Therapy
Primary outcomes (1)
- measure
- Proportion of participants who completed ≥70% BLT sessions, with a minimum of 7 consecutive days of monitoring.
- timeFrame
- Baseline through the day prior to Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks).
- description
- 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 outcomes (2)
- measure
- Number of Participants with Adverse Events (AEs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (23)
- BACKGROUNDYing X, Freedland KE, Powell LH, Stuart EA, Ehrhardt S, Mayo-Wilson E. Determining sample size for pilot trials: a tutorial. BMJ. 2025 Aug 8;390:e083405. doi: 10.1136/bmj-2024-083405. No abstract available. PMID 40780848
- BACKGROUNDTulppo MP, Jurvelin H, Roivainen E, Nissila J, Hautala AJ, Kiviniemi AM, Kiviniemi VJ, Takala T. Effects of bright light treatment on psychomotor speed in athletes. Front Physiol. 2014 May 12;5:184. doi: 10.3389/fphys.2014.00184. eCollection 2014. PMID 24860513
- BACKGROUNDWittenbrink N, Ananthasubramaniam B, Munch M, Koller B, Maier B, Weschke C, Bes F, de Zeeuw J, Nowozin C, Wahnschaffe A, Wisniewski S, Zaleska M, Bartok O, Ashwal-Fluss R, Lammert H, Herzel H, Hummel M, Kadener S, Kunz D, Kramer A. High-accuracy determination of internal circadian time from a single blood sample. J Clin Invest. 2018 Aug 31;128(9):3826-3839. doi: 10.1172/JCI120874. Epub 2018 Aug 6. PMID 29953415
- BACKGROUNDLandre T, Karaboue A, Buchwald ZS, Innominato PF, Qian DC, Assie JB, Chouaid C, Levi F, Duchemann B. Effect of immunotherapy-infusion time of day on survival of patients with advanced cancers: a study-level meta-analysis. ESMO Open. 2024 Feb;9(2):102220. doi: 10.1016/j.esmoop.2023.102220. Epub 2024 Jan 16. PMID 38232612
- BACKGROUNDNagare R, Rea MS, Plitnick B, Figueiro MG. Nocturnal Melatonin Suppression by Adolescents and Adults for Different Levels, Spectra, and Durations of Light Exposure. J Biol Rhythms. 2019 Apr;34(2):178-194. doi: 10.1177/0748730419828056. Epub 2019 Feb 25. PMID 30803301
- BACKGROUNDLai F, Luo Z, Zhang J, Xia W, Tian L. Bright light therapy has a positive effect on sleep quality in patients with cancer: A meta-analysis. Sleep Med Rev. 2024 Jun;75:101925. doi: 10.1016/j.smrv.2024.101925. Epub 2024 Mar 21. PMID 38537515
- BACKGROUNDJohnson JA, Garland SN, Carlson LE, Savard J, Simpson JSA, Ancoli-Israel S, Campbell TS. Bright light therapy improves cancer-related fatigue in cancer survivors: a randomized controlled trial. J Cancer Surviv. 2018 Apr;12(2):206-215. doi: 10.1007/s11764-017-0659-3. Epub 2017 Nov 10.