Bright Light Therapy in Patients With Melanoma or Non-small Cell Lung Cancer (NSCLC) Who Are Receiving First-Line Immune Checkpoint Blockade (IIT BLT)
23 juin 2026 mis à jour par: Weill Medical College of Cornell University
A Pilot Trial of Bright Light Therapy in Patients Receiving First Line Immune Checkpoint Blockade
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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Intervention / Traitement
Description détaillée
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).
Type d'étude
Interventionnel
Inscription (Estimé)
12
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: June Greenberg, BSN, RN, OCN, CCRP, CCRC
- Numéro de téléphone: 212-746-2651
- E-mail: jdg2002@med.cornell.edu
Sauvegarde des contacts de l'étude
- Nom: Daniella Topol, RN
- E-mail: dat7032@med.cornell.edu
Lieux d'étude
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New York
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New York, New York, États-Unis, 10021
- Weill Cornell Medicine
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Contact:
- Daniella Topol Topol
- E-mail: dat7032@med.cornell.edu
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Chercheur principal:
- Paul Chapman, MD
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Sous-enquêteur:
- Jessica Palmer, MD
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Sous-enquêteur:
- Christine Garcia, MD
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Sous-enquêteur:
- Anna Pavlick, DO
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Sous-enquêteur:
- Ashish Saxena, MD
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Contact:
- June Greenberg
- Numéro de téléphone: (212)-746-2651
- E-mail: jdg2002@med.cornell.edu
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Age ≥18 years.
- Histologically confirmed diagnosis of advanced, unresectable melanoma or NSCLC.
- Presence of measurable tumor burden.
- 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).
- ECOG performance status 0-2.
- Able to provide informed consent.
- Access to reliable internet connection via WiFi or personal hotspot
Exclusion Criteria:
- Previous exposure to immune checkpoint blockade.
- Pregnant or breastfeeding.
- Use of melatonin or pharmacologic sleep aids (e.g., zolpidem, trazodone, benzodiazepines) within 14 days prior to enrollment.
- Diagnosis of bipolar disorder or history of mania or hypomania.
- Active psychosis, suicidal ideation, or recent psychiatric hospitalization (<3 months).
- Poorly controlled seizures.
- Chronotype classified as extremely early or extremely late, based on the Munich Chronotype Questionnaire (MSFsc < 2:00 or > 5:00).
- Night shift work within the past 30 days or expected during the intervention.
- Travel across ≥2 time zones within the past 14 days.
- Diagnosed or suspected untreated moderate to severe obstructive sleep apnea.
- Migraine with photophobia.
- 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).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Single-arm: adherence to 60 mins of daily Bright Light Therapy for >7 days prior to ICB initiation
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of participants who completed ≥70% BLT sessions, with a minimum of 7 consecutive days of monitoring.
Délai: Baseline through the day prior to Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks).
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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).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants with Adverse Events (AEs)
Délai: Baseline through first Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks).
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This will include adverse events, serious adverse events, and unanticipated adverse device effects.
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Baseline through first Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks).
|
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Proportion of Participants with Adverse Events (AEs)
Délai: 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.
|
Baseline through first Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks).
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Paul Chapman, MD, Weill Medical College of Cornell University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Johnson 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.
- van Maanen A, Meijer AM, van der Heijden KB, Oort FJ. The effects of light therapy on sleep problems: A systematic review and meta-analysis. Sleep Med Rev. 2016 Oct;29:52-62. doi: 10.1016/j.smrv.2015.08.009. Epub 2015 Sep 9.
- Wittenbrink 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.
- Geoffroy PA, Schroder CM, Reynaud E, Bourgin P. Efficacy of light therapy versus antidepressant drugs, and of the combination versus monotherapy, in major depressive episodes: A systematic review and meta-analysis. Sleep Med Rev. 2019 Dec;48:101213. doi: 10.1016/j.smrv.2019.101213. Epub 2019 Sep 18.
- Rea MS, Figueiro MG, Bullough JD, Bierman A. A model of phototransduction by the human circadian system. Brain Res Brain Res Rev. 2005 Dec 15;50(2):213-28. doi: 10.1016/j.brainresrev.2005.07.002. Epub 2005 Oct 7.
- Comtet H, Geoffroy PA, Kobayashi Frisk M, Hubbard J, Robin-Choteau L, Calvel L, Hugueny L, Viola AU, Bourgin P. Light therapy with boxes or glasses to counteract effects of acute sleep deprivation. Sci Rep. 2019 Dec 2;9(1):18073. doi: 10.1038/s41598-019-54311-x.
- Wang C, Zeng Q, Gul ZM, Wang S, Pick R, Cheng P, Bill R, Wu Y, Naulaerts S, Barnoud C, Hsueh PC, Moller SH, Cenerenti M, Sun M, Su Z, Jemelin S, Petrenko V, Dibner C, Hugues S, Jandus C, Li Z, Michielin O, Ho PC, Garg AD, Simonetta F, Pittet MJ, Scheiermann C. Circadian tumor infiltration and function of CD8+ T cells dictate immunotherapy efficacy. Cell. 2024 May 23;187(11):2690-2702.e17. doi: 10.1016/j.cell.2024.04.015. Epub 2024 May 8.
- Ying 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.
- Tulppo 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.
- Landre 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.
- Nagare 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.
- Lai 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.
- Yennurajalingam S, Carmack C, Balachandran D, Eng C, Lim B, Delgado M, Guzman Gutierrez D, Raznahan M, Park M, Hess KR, Williams JL, Lu Z, Ochoa J, Bruera E. Sleep disturbance in patients with cancer: a feasibility study of multimodal therapy. BMJ Support Palliat Care. 2021 Jun;11(2):170-179. doi: 10.1136/bmjspcare-2019-001877. Epub 2020 Jan 10.
- Neikrug AB, Rissling M, Trofimenko V, Liu L, Natarajan L, Lawton S, Parker BA, Ancoli-Israel S. Bright light therapy protects women from circadian rhythm desynchronization during chemotherapy for breast cancer. Behav Sleep Med. 2012;10(3):202-16. doi: 10.1080/15402002.2011.634940.
- Munch M, Goldbach R, Zumstein N, Vonmoos P, Scartezzini JL, Wirz-Justice A, Cajochen C. Preliminary evidence that daily light exposure enhances the antibody response to influenza vaccination in patients with dementia. Brain Behav Immun Health. 2022 Sep 20;26:100515. doi: 10.1016/j.bbih.2022.100515. eCollection 2022 Dec.
- Burgess HJ, Park M, Ong JC, Shakoor N, Williams DA, Burns J. Morning Versus Evening Bright Light Treatment at Home to Improve Function and Pain Sensitivity for Women with Fibromyalgia: A Pilot Study. Pain Med. 2017 Jan 1;18(1):116-123. doi: 10.1093/pm/pnw160.
- Leichtfried V, Matteucci Gothe R, Kantner-Rumplmair W, Mair-Raggautz M, Bartenbach C, Guggenbichler H, Gehmacher D, Jonas L, Aigner M, Winkler D, Schobersberger W. Short-term effects of bright light therapy in adults with chronic nonspecific back pain: a randomized controlled trial. Pain Med. 2014 Dec;15(12):2003-12. doi: 10.1111/pme.12503. Epub 2014 Aug 26.
- Song C, Luchtman D, Kang Z, Tam EM, Yatham LN, Su KP, Lam RW. Enhanced inflammatory and T-helper-1 type responses but suppressed lymphocyte proliferation in patients with seasonal affective disorder and treated by light therapy. J Affect Disord. 2015 Oct 1;185:90-6. doi: 10.1016/j.jad.2015.06.003. Epub 2015 Jun 17.
- Gouldthorpe C, Power J, Davies A. Circadian rhythm disorders in patients with advanced cancer: a scoping review. Front Oncol. 2023 Sep 26;13:1240284. doi: 10.3389/fonc.2023.1240284. eCollection 2023.
- Valdimarsdottir HB, Figueiro MG, Holden W, Lutgendorf S, Wu LM, Ancoli-Israel S, Chen J, Hoffman-Peterson A, Granski J, Prescott N, Vega A, Stern N, Winkel G, Redd WH. Programmed environmental illumination during autologous stem cell transplantation hospitalization for the treatment of multiple myeloma reduces severity of depression: A preliminary randomized controlled trial. Cancer Med. 2018 Sep;7(9):4345-4353. doi: 10.1002/cam4.1690. Epub 2018 Aug 11.
- Figueiro MG, Steverson B, Heerwagen J, Kampschroer K, Hunter CM, Gonzales K, Plitnick B, Rea MS. The impact of daytime light exposures on sleep and mood in office workers. Sleep Health. 2017 Jun;3(3):204-215. doi: 10.1016/j.sleh.2017.03.005. Epub 2017 Apr 23.
- Figueiro MG, Plitnick BA, Lok A, Jones GE, Higgins P, Hornick TR, Rea MS. Tailored lighting intervention improves measures of sleep, depression, and agitation in persons with Alzheimer's disease and related dementia living in long-term care facilities. Clin Interv Aging. 2014 Sep 12;9:1527-37. doi: 10.2147/CIA.S68557. eCollection 2014.
- Lewy AJ, Wehr TA, Goodwin FK, Newsome DA, Markey SP. Light suppresses melatonin secretion in humans. Science. 1980 Dec 12;210(4475):1267-9. doi: 10.1126/science.7434030.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juin 2026
Achèvement primaire (Estimé)
1 décembre 2027
Achèvement de l'étude (Estimé)
1 décembre 2027
Dates d'inscription aux études
Première soumission
17 juin 2026
Première soumission répondant aux critères de contrôle qualité
17 juin 2026
Première publication (Réel)
22 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Tumeurs par site
- Tumeurs
- Maladies des voies respiratoires
- Tumeurs par type histologique
- Maladies pulmonaires
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Tumeurs pulmonaires
- Maladies de la peau
- Tumeurs neuroectodermiques
- Tumeurs, cellules germinales et embryonnaires
- Tumeurs, tissu nerveux
- Carcinome bronchique
- Tumeurs bronchiques
- Tumeurs neuroendocrines
- Nevi et mélanomes
- Tumeurs cutanées
- Maladies de la peau et du tissu conjonctif
- Carcinome pulmonaire non à petites cellules
- Mélanome
- Thérapeutique
- Photothérapie
- Thérapie ultraviolette
Autres numéros d'identification d'étude
- 25-10029453
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .