Bright Light Therapy in Patients With Melanoma or Non-small Cell Lung Cancer (NSCLC) Who Are Receiving First-Line Immune Checkpoint Blockade (IIT BLT)
2026년 6월 17일 업데이트: 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.
연구 개요
상세 설명
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).
연구 유형
중재적
등록 (추정된)
12
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: June Greenberg, BSN, RN, OCN, CCRP, CCRC
- 전화번호: 212-746-2651
- 이메일: jdg2002@med.cornell.edu
연구 연락처 백업
- 이름: Daniella Topol, RN
- 이메일: dat7032@med.cornell.edu
연구 장소
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New York
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New York, New York, 미국, 10021
- Weill Cornell Medicine
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연락하다:
- June Greenberg
- 전화번호: 212-746-2651
- 이메일: jdg2002@med.cornell.edu
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연락하다:
- Daniella Topol Topol
- 이메일: dat7032@med.cornell.edu
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수석 연구원:
- Paul Chapman, MD
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부수사관:
- Jessica Palmer, MD
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부수사관:
- Christine Garcia, MD
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부수사관:
- Anna Pavlick, DO
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부수사관:
- Ashish Saxena, MD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Single-arm: adherence to 60 minutes of daily Bright Light Therapy for >7 days prior to ICB initia
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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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Proportion of participants who completed ≥70% BLT sessions, with a minimum of 7 consecutive days of monitoring.
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants with Adverse Events (AEs)
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Paul Chapman, MD, Weill Medical College of Cornell University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 1일
기본 완료 (추정된)
2027년 12월 1일
연구 완료 (추정된)
2027년 12월 1일
연구 등록 날짜
최초 제출
2026년 6월 17일
QC 기준을 충족하는 최초 제출
2026년 6월 17일
처음 게시됨 (실제)
2026년 6월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 17일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 25-10029453
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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