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 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
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).
Tipo de estudio
Intervencionista
Inscripción (Estimado)
12
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: June Greenberg, BSN, RN, OCN, CCRP, CCRC
- Número de teléfono: 212-746-2651
- Correo electrónico: jdg2002@med.cornell.edu
Copia de seguridad de contactos de estudio
- Nombre: Daniella Topol, RN
- Correo electrónico: dat7032@med.cornell.edu
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10021
- Weill Cornell Medicine
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Contacto:
- Daniella Topol Topol
- Correo electrónico: dat7032@med.cornell.edu
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Investigador principal:
- Paul Chapman, MD
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Sub-Investigador:
- Jessica Palmer, MD
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Sub-Investigador:
- Christine Garcia, MD
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Sub-Investigador:
- Anna Pavlick, DO
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Sub-Investigador:
- Ashish Saxena, MD
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Contacto:
- June Greenberg
- Número de teléfono: (212)-746-2651
- Correo electrónico: jdg2002@med.cornell.edu
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Single-arm: adherence to 60 mins of daily Bright Light Therapy for >7 days prior to ICB initiation
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of participants who completed ≥70% BLT sessions, with a minimum of 7 consecutive days of monitoring.
Periodo de tiempo: 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.
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Baseline through the day prior to Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants with Adverse Events (AEs)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Paul Chapman, MD, Weill Medical College of Cornell University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
1 de diciembre de 2027
Finalización del estudio (Estimado)
1 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
17 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de junio de 2026
Publicado por primera vez (Actual)
22 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
23 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de las vías respiratorias
- Neoplasias por tipo histológico
- Enfermedades pulmonares
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Neoplasias Pulmonares
- Enfermedades de la piel
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Tumores neuroendocrinos
- Nevos y Melanomas
- Neoplasias De La Piel
- Enfermedades de la piel y del tejido conectivo
- Carcinoma de pulmón de células no pequeñas
- Melanoma
- Terapéutica
- Fototerapia
- Terapia ultravioleta
Otros números de identificación del estudio
- 25-10029453
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .