12 Participants NeededMy employer runs this trial

Bright Light Therapy for Skin and Lung Cancer

(IIT BLT Trial)

DT
Overseen ByDaniella Topol, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Weill Medical College of Cornell University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether bright light therapy can improve the body's internal clock (circadian rhythm) in individuals with advanced skin or lung cancer. By aligning the circadian rhythm, researchers aim to enhance the effectiveness of immunotherapy treatments. Participants will use an iPad app for daily light therapy sessions before beginning their cancer treatment. Individuals with advanced melanoma or non-small cell lung cancer who have not yet started specific immunotherapy treatments may qualify for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that may enhance future cancer treatments.

What prior data suggests that bright light therapy is safe for cancer patients?

A study showed that bright light therapy (BLT) helps cancer patients sleep better, especially with stronger light. Patients generally tolerate it well. Research has found no increased risk of skin cancer in patients receiving similar light treatments. However, excessive UV light can harm the skin, so safe use is crucial. Overall, BLT appears to be a safe method for helping cancer patients manage their sleep-wake cycles.12345

Why are researchers excited about this trial?

Bright Light Therapy is unique because it uses non-invasive light exposure to potentially boost the immune response against skin and lung cancer. Unlike standard treatments such as chemotherapy or immunotherapy, which often have significant side effects, Bright Light Therapy is gentle and targets the body’s natural rhythms to enhance treatment efficacy. Researchers are excited about this approach because it could improve patient outcomes with fewer side effects, making cancer treatment more tolerable and accessible.

What evidence suggests that bright light therapy is effective for synchronizing circadian rhythms in cancer patients?

Research has shown that bright light therapy (BLT) can help reset the body's natural sleep-wake cycle, known as the circadian rhythm. This alignment is crucial because it may enhance the body's response to cancer treatments like immunotherapy. Some studies suggest that patients with well-synced circadian rhythms have a higher likelihood of benefiting from these treatments. Bright light therapy has proven effective in aligning circadian rhythms. Although direct evidence of its impact on cancer treatment is still emerging, the potential for improved outcomes through better-timed immunotherapy is promising. Participants in this trial will undergo 60 minutes of daily Bright Light Therapy for more than 7 days before starting immune checkpoint blockade (ICB) therapy.678910

Who Is on the Research Team?

PC

Paul Chapman, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults with melanoma or non-small cell lung cancer who are about to start their first immune checkpoint blocker (immunotherapy) treatment. Participants should be able to use an iPad app and follow the daily light therapy schedule.

Inclusion Criteria

Access to reliable internet connection via WiFi or personal hotspot
I am 18 years old or older.
Able to provide informed consent
See 4 more

Exclusion Criteria

Pregnant or breastfeeding
Chronotype classified as extremely early or extremely late, based on the Munich Chronotype Questionnaire (MSFsc < 2:00 or > 5:00)
Active psychosis, suicidal ideation, or recent psychiatric hospitalization (<3 months)
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Bright Light Therapy

Participants receive 60 minutes of daily bright light therapy for more than 7 days prior to starting immune checkpoint blockade

1-3 weeks
Daily sessions (self-administered)

Immune Checkpoint Blockade Treatment

Participants receive immune checkpoint blockade therapy, potentially in combination with chemotherapy

Varies based on treatment regimen

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Bright Light Therapy

Trial Overview

The study tests if using bright light therapy for one hour each morning, via an iPad app, before starting immunotherapy helps align patients' sleep-wake cycles and is practical for people with these cancers.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Single-arm: adherence to 60 mins of daily Bright Light Therapy for >7 days prior to ICB initiationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+

Circadian OS

Collaborator

Circadian OS, Inc

Industry Sponsor

Citations

Effectiveness

In medicine, effectiveness relates to how well a treatment works in practice, especially as shown in pragmatic clinical trials, as opposed to efficacy,

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/24330006/

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