Bright Light Therapy in Patients With Melanoma or Non-small Cell Lung Cancer (NSCLC) Who Are Receiving First-Line Immune Checkpoint Blockade (IIT BLT)
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.
調査の概要
詳細な説明
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).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：June Greenberg, BSN, RN, OCN, CCRP, CCRC
- 電話番号：212-746-2651
- メール：jdg2002@med.cornell.edu
研究連絡先のバックアップ
- 名前：Daniella Topol, RN
- メール：dat7032@med.cornell.edu
研究場所
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New York
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New York、New York、アメリカ、10021
- Weill Cornell Medicine
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コンタクト：
- Daniella Topol Topol
- メール：dat7032@med.cornell.edu
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主任研究者：
- Paul Chapman, MD
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副調査官：
- Jessica Palmer, MD
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副調査官：
- Christine Garcia, MD
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副調査官：
- Anna Pavlick, DO
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副調査官：
- Ashish Saxena, MD
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コンタクト：
- June Greenberg
- 電話番号：(212)-746-2651
- メール：jdg2002@med.cornell.edu
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of participants who completed ≥70% BLT sessions, with a minimum of 7 consecutive days of monitoring.
時間枠：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).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants with Adverse Events (AEs)
時間枠：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)
時間枠：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).
|
協力者と研究者
協力者
捜査官
- 主任研究者：Paul Chapman, MD、Weill Medical College of Cornell University
出版物と役立つリンク
一般刊行物
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- 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.
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- 25-10029453
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