A Pilot Trial of Bright Light Therapy in Patients Receiving First Line Immune Checkpoint Blockade
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Proportion of participants who completed ≥70% BLT sessions, with a minimum of 7 consecutive days of monitoring.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Able to provide informed consent.
- •Access to reliable internet connection via WiFi or personal hotspot
排除标准
- •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).
结局指标
主要结局
Proportion of participants who completed ≥70% BLT sessions, with a minimum of 7 consecutive days of monitoring.
时间窗: 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.
次要结局
- Number of Participants with Adverse Events (AEs)(Baseline through first Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks).)
- Proportion of Participants with Adverse Events (AEs)(Baseline through first Immune-Checkpoint Blockade administration (expected to be approximately 1-3 weeks).)