Sleep and Circadian Rhythm Study in Head and Neck Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Development of oral mucositis (OM)
研究概览
简要总结
This clinical trial studies the effect and underlying mechanisms of sleep and circadian rhythm factors on oral mucositis pain in head and neck cancer patients treated by chemoradiotherapy. Poor sleep may have a correlation to increased pain. A behavioral intervention, Brief Behavioral Therapy for Cancer related Insomnia, may improve patients' sleep and may also reduce oral mucositis pain.
详细描述
PRIMARY OBJECTIVES:
I. To examine the effect and underlying mechanisms of sleep and circadian rhythm factors on oral mucositis pain in head and neck cancer patients treated by chemoradiotherapy.
Ia. To assess the impact of chemo-radiotherapy (CRT) on the onset and duration of sleep disturbance in head and neck carcinoma (HNC) patients, and identify factors that trigger or aggravate sleep disturbance.
Ib. To examine the effect of the association between sleep and CRT-induced oral mucositis (OM) pain.
SECONDARY OBJECTIVE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patients with histologically confirmed head and neck squamous cell carcinoma who have a CRT treatment scheduled at Roswell Park
- •Age >= 18 years of age
- •Able to read, comprehend and speak the English language
- •Willing to wear a wristwatch (actiwatch) and complete the sleep log to monitor sleep and activity for three weeks (Week 1, 3, and 6) during CRT
- •Willing to wear the ApneaLink Air at-home sleep monitor for one night at baseline (pre-CRT)
- •Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
- •Willing to provide biospecimen samples (saliva, cheek cells, and blood) twice during CRT (week 1 and week 4) and optional for week 6
- •ADDITIONAL INTERVENTIONAL STUDY CRITERIA
- •Insomnia Severity Index (ISI) total score >= 7
- •Willing to complete a course of Brief Behavioral Therapy for Insomnia (BBT-CI) during the treatment weeks
排除标准
- •Participant does not meet the overall Inclusion Criteria for this study
- •Patients who developed severe oral mucositis with World Health Organization Scale III or above with ulcers on the cheeks
- •ADDITIONAL INTERVENTION STUDY (BBT-CI): Currently receiving treatment for insomnia or other sleep disorders
- •ADDITIONAL INTERVENTION STUDY (BBT-CI): History of severe mental illness
- •ADDITIONAL INTERVENTION STUDY (BBT-CI): Attending behavioral intervention programs for smoking cessation or other substance use disorders
- •ADDITIONAL INTERVENTION STUDY (BBT-CI): Shift workers or persons with a known sleep disorder affecting regular sleep phase initiation (e.g. sleep onset outside the 9 pm- 12 am hours)
- •Unwilling or unable to follow protocol requirements
- •Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for study participation
- •Cognitively impaired adults/adults with impaired decision-making capacity, individuals who are not yet adults (infants, children, and teenagers), pregnant women, and prisoners are all excluded from this study
结局指标
主要结局
Development of oral mucositis (OM)
时间窗: Up to 1 year
OM is assessed weekly during treatment by clinical exam and patient reported Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (OMWQ-HN).
Insomnia Severity Index (ISI)
时间窗: Up to 1 year
A brief questionnaire where the total responses are added up with higher scores indicating more acute symptoms of insomnia.
Self-reported oral mucositis pain
时间窗: Up to 1 year
OM pain is assessed using a visual analog scale that rates patients' overall mouth and throat soreness, on a scale of 0-10, weekly during CRT and after chemoradiotherapy (CRT) up to one year at follow up visits.
Sleep Efficiency
时间窗: Up to 1 year
Will be measured by using a non-invasive wrist actigraphy monitor.
Sleep Disturbance
时间窗: Up to 1 year
Sleep diaries will assess sleep and wake time
次要结局
- Systemic inflammatory markers will include IL-6, IL1b and TNF.(Up to 1 year)
- Correlation of sleep measurement with total opioid use(Up to 1 year)