This phase I trial tests the effect of Circadian-Optimized Light Therapy (COLT) in conjunction with standard of care tumor-infiltrating lymphocytes (TIL) therapy in treating patients with melanoma that may have spread from where it first started to nearby tissue, lymph nodes or distant parts of the body (advanced). Circadian rhythm is the body's natural 24 hour clock which helps keep the body operating on a healthy wake-sleep cycle. Exposure to morning light has been shown to have a positive impact. Patients with advanced cancers often experience circadian disruption, including exposure to hospital-related light, treatment side effects, and inflammation. TIL are made by collecting and growing specialized T cells (a type of white blood cell) from a patient's tumor and given back to the patient to help stimulate the immune system in different ways to stop tumor cells from growing. However, disruptions in the circadian rhythm may impact the effectiveness of TIL therapy. COLT is a home-based digital intervention that delivers circadian-effective morning light using the Circadian OS iPad application. Daily light exposure may help prevent circadian disruption and improve immune and inflammatory responses. Adding COLT sessions to standard of care therapy with TIL may be safe and tolerable in patients with advanced melanoma.
Documented informed consent of the participant and/or legally authorized representative
Age: ≥ 18 years
Ability to read and understand English for questionnaires
Progression on or after immune checkpoint inhibitor therapy
Explicit Munich Chronotype Questionnaire (MCTQ) cutoffs (< 2:00, > 5:00)
Use of melatonin or pharmacologic sleep aids (e.g., zolpidem, trazodone, benzodiazepines) within 14 days prior to enrollment
Night shift work within the past 30 days or expected during the intervention
Travel across ≥ 2 time zones within the past 14 days
Single group
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Internet-Based Intervention
Other interventionReceive access to Circadian OS application
Medical Device Usage and Evaluation
Other interventionWear wrist actigraphy
Phototherapy
Procedure/SurgeryUndergo light therapy sessions
Questionnaire Administration
Other interventionAncillary studies
Therapeutic Tumor Infiltrating Lymphocytes
Biological/VaccineGiven infusion
Adherence
Will be measured as the proportion of prescribed daily Circadian-Optimized Light Therapy (COLT) sessions attempted by each participant. Session initiation, duration, and completion will be automatically recorded by the Circadian OS application and verified at scheduled study visits. Participants who attempt at least 50% of sessions will be considered adherent. Adherence data will be summarized descriptively, including the median and range of completion rates across participants. Will be reported with a two-sided 95% exact (Clopper-Pearson) confidence interval.
Incidence, severity, and attribution of COLT-related treatment-emergent adverse events
Will be graded by Common Terminology Criteria for Adverse Events version 5.0.
Patient-reported acceptability and usability of COLT
Will be assessed using the Acceptability of Intervention Measure questionnaire. Responses will be summarized as total and subscale scores with means, standard deviations, medians, and ranges. The proportion of participants meeting a predefined threshold for acceptability or usability on the instrument's scale will also be reported with exact 95 percent confidence intervals.
Patient scores for quality of life and symptom burden
Will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative Care. Data will be evaluated for functional scale, global health status, and symptoms. Scores will be summarized descriptively and compared across study phases.
Patient scores for fatigue
Will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue questionnaire. Data will be evaluated for functional scale, global health status, and symptoms. Scores will be summarized descriptively and compared across study phases.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
