Melanoma (Skin Cancer)IIT BLTNCT07661966

Bright Light Therapy in Patients With Melanoma or Non-small Cell Lung Cancer (NSCLC) Who Are Receiving First-Line Immune Checkpoint Blockade

A study testing Bright Light Therapy in people with Melanoma (Skin Cancer) and NSCLC (Non-small Cell Lung Cancer), run by Weill Medical College of Cornell University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Melanoma (Skin Cancer), NSCLC (Non-small Cell Lung Cancer)
What is being tested?: Bright Light Therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 3 Oct 2026to Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 12Show fewer

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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

June Greenberg, BSN, RN, OCN, CCRP, CCRC contact

212-746-2651

jdg2002@med.cornell.edu

Daniella Topol, RN contact

dat7032@med.cornell.edu

United States1 site, 1 recruiting

Weill Cornell Medicine
New York, New York, 10021
June Greenberg, (212)-746-2651, jdg2002@med.cornell.edu
Daniella Topol Topol, dat7032@med.cornell.edu
Recruiting

Other trials in United States

About this study

Official title: A Pilot Trial of Bright Light Therapy in Patients Receiving First Line Immune Checkpoint Blockade

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.

Read the detailed description

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).

Conditions: Melanoma (Skin Cancer), NSCLC (Non-small Cell Lung Cancer)
Being tested: Bright Light Therapy
Keywords: IIT BLT, Bright Light Therapy, Circadian, Circadian Rhythm
Medical subject headings: Melanoma, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bright Light TherapyDevice
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.

Study groups in NCT07661966
Study group	Role	What they receive
Single-arm: adherence to 60 mins of daily Bright Light Therapy for >7 days prior to ICB initiation	Experimental	Not described Receives: Device: Bright Light Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of participants who completed ≥70% BLT sessions, with a minimum of 7 consecutive days of monitoring.
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.
Measured: Baseline through the day prior to Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks).

Secondary outcomes (2)

Number of Participants with Adverse Events (AEs)
This will include adverse events, serious adverse events, and unanticipated adverse device effects.
Measured: Baseline through first Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks).
Proportion of Participants with Adverse Events (AEs)
This will include adverse events, serious adverse events, and unanticipated adverse device effects.
Measured: Baseline through first Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Oct 2026Dec 2027

First posted22 Jun 2026
Study start3 Oct 2026 (estimated)
Primary completionDec 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Melanoma (Skin Cancer)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07661966
Sponsor's protocol ID: 25-10029453
Acronym: IIT BLT
Status last verified: Sep 2026
First submitted: 17 Jun 2026
Last updated: 23 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 40780848
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.
PubMed 24860513
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.
PubMed 29953415
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.
PubMed 38232612
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.
PubMed 30803301
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.
PubMed 38537515
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.
PubMed 29127575
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.
PubMed 31924662
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.
PubMed 22742438
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.
PubMed 36193044
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.
PubMed 27473633
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.
PubMed 25159085
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.
PubMed 26606319
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.
PubMed 26148465
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.
PubMed 31792259

Interested in taking part?

June Greenberg, BSN, RN, OCN, CCRP, CCRC

212-746-2651

jdg2002@med.cornell.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Melanoma (Skin Cancer) trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Trial of Bright Light Therapy in Patients Receiving First Line Immune Checkpoint Blockade
ClinicalTrials.gov ID: NCT07661966
Acronym / sponsor ID: IIT BLT / 25-10029453
Conditions: Melanoma (Skin Cancer), NSCLC (Non-small Cell Lung Cancer)
Keywords: IIT BLT, Bright Light Therapy, Circadian, Circadian Rhythm
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 12 participants (estimated)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: Circadian OS, Inc
Study start: 3 Oct 2026 (estimated)
Primary completion: Dec 2027 (estimated)
Study completion: Dec 2027 (estimated)
First posted: 22 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single-arm: adherence to 60 mins of daily Bright Light Therapy for >7 days prior to ICB initiation	Experimental	Device: Bright Light Therapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (12 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bright Light TherapyBright 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.	Device	Single-arm: adherence to 60 mins of daily Bright Light Therapy for >7 days prior to ICB initiation

Primary outcome

Proportion of participants who completed ≥70% BLT sessions, with a minimum of 7 consecutive days of monitoring.
Time frame: Baseline through the day prior to Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks).
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.

2 secondary outcomes

Number of Participants with Adverse Events (AEs)
Time frame: Baseline through first Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks).
Proportion of Participants with Adverse Events (AEs)
Time frame: Baseline through first Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks).

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Background: PubMed 40780848Ying 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.
Background: PubMed 24860513Tulppo 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.
Background: PubMed 29953415Wittenbrink 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.
Background: PubMed 38232612Landre 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.
Background: PubMed 30803301Nagare 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.
Background: PubMed 38537515Lai 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.
Background: PubMed 29127575Johnson 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.
Background: PubMed 31924662Yennurajalingam 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.
Background: PubMed 22742438Neikrug 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.
Background: PubMed 36193044Munch 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.
Background: PubMed 27473633Burgess 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.
Background: PubMed 25159085Leichtfried 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

June Greenberg, BSN, RN, OCN, CCRP, CCRC contact

212-746-2651

jdg2002@med.cornell.edu

Daniella Topol, RN contact

dat7032@med.cornell.edu

Paul Chapman, MD principal investigator

Weill Medical College of Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bright Light Therapy in people with Melanoma (Skin Cancer) and NSCLC (Non-small Cell Lung Cancer), run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact June Greenberg, BSN, RN, OCN, CCRP, CCRC (212-746-2651, jdg2002@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants who completed ≥70% BLT sessions, with a minimum of 7 consecutive days of monitoring. (time frame: Baseline through the day prior to Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07661966, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.