Clinical trial NCT04922112: Sleep Apnea in Head and Neck Cancer Patients at the University of Colorado
Official title: Sleep Apnea in Head and Neck Cancer Patients at the University of Colorado
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Squamous Cell Carcinoma of Head and Neck
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-06-10
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Obstructive sleep apnea (OSA) is increasingly recognized in patients with squamous cell carcinoma of the head and neck (SCCHN). The prevalence prior and after cancer therapy is not well understood. OSA is identified as a contributing factor for daytime somnolence and quality of life (QOL), yet treatment of OSA in the SCCHN population has not been studied. The investigators hope to identify the disease course of sleep apnea, risk factors for development, and impact on QOL with treatment of OSA in a population of patients with SCCHN.

Detailed description: The investigators will conduct a prospective cohort study of enrolled patients seen in initial consultation by our H\&N cancer surgeons and/or Radiation Oncologists either at AMC or HRH. Data collected from patients in the form of quality of life and sleep questionnaires and home sleep study (Alice Night One System by Phillips Respironics), as well as data from the electronic medical record will be coded into RedCap.

Blood collection for inflammatory biomarkers will occur during routine laboratory workup to avoid unnecessary phlebotomy whenever possible. Blood laboratory specimens of the inflammatory markers will be centrifuged to plasma and stored at -80C in freezers located on the Anschutz campus in Research Complex 2 on the 7th floor. Patients who require tracheostomy will be included in this study but will not have any sleep study time-point as indicated. Patients who are identified to have OSA will undergo counseling and treatment as per standard of care. CPAP compliance data will be collected every three months after initiation of OSA treatment.

Patient details including demographics, treatment information such as surgery, radiation, and chemotherapy, sleep and quality of life questionnaire data, pro-inflammatory cytokines, and sleep study results will collected. The RedCap database will be maintained by the PI, or their delegate of the present study, and all persons utilizing the RedCap database for purposes of entering data will be included on the Delegation of Authority.

Eligibility criteria: Inclusion Criteria:

1. Subjects between the ages of 21 (inclusive) and 90 (inclusive). Anyone that is over 89 years old will be labeled as 89 in the data analysis.
2. Patients with an established relationship with the adult Otolaryngology and/or Radiation Oncology clinic at AMC or HRH.
3. Patients that present with a new diagnosis of oropharyngeal SCC who undergo radiation treatment, with or without chemotherapy.
4. Patients who may require trachesotomy will be included.
5. Stated willingness to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria:

1. Under the age of 21 or over the age of 90.
2. Unwilling to sign the informed consent.
3. Unable or unwilling to participate in sleep studies.
4. Patients who have had a prior diagnosis of SCCa of the head and neck including nasopharynx, oral cavity, oropharynx, larynx and hypopharynx will be excluded. Patients with prior non-cutnaeous non-SCC tumors of the head and neck will also be excluded. Patients with prior skin cancer diagnoses will not be excluded.

Primary outcomes:
measure: FOSQ-10 (Functional Outcomes of Sleep Questionnaire)
timeFrame: 72 weeks
measure: EORTC-HN35 (European Organization for Research and Treatment of Cancer)
timeFrame: 72 weeks
measure: ESS (Epworth Sleepiness Scale)
timeFrame: 72 weeks
measure: ACE-27 (Adult Comorbidity Evaluation 27)
timeFrame: 72 weeks
measure: UW-QOL (University of Washington Quality of Life Questionnaire)
timeFrame: 72 weeks
measure: Chronic Pain Assessment
timeFrame: 72 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
References: