Sleep Apnea in Head and Neck Cancer Patients at the University of Colorado

NCT04922112 | Withdrawn

• 2 other identifiers: 20-1778.ccP30CA046934
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Squamous Cell Carcinoma of Head and Neck

Outcome Measures

Primary Outcomes (6)

• FOSQ-10 (Functional Outcomes of Sleep Questionnaire)

  Measurement of daytime somnolence impact on activities of daily living. Score 0-4 for each item, with a score range of 5-20, higher scores with better outcome

  72 weeks

• EORTC-HN35 (European Organization for Research and Treatment of Cancer)

  European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-QLQ-H\&N35. Qquality of life assessment in head and neck cancer patients. A raw score is calculated as a mean of the component items, then a linear transformation is performed with score of 0 to 100; the summary score is an average of the raw scores of each group of questions. A higher scores indicate greater impairment.

  72 weeks

• ESS (Epworth Sleepiness Scale)

  A measure of daytime sleepiness. Score 0-4 for each item, score range 0-24, higher scores with worse outcome.

  72 weeks

• ACE-27 (Adult Comorbidity Evaluation 27)

  Comorbidity instrument/severity. Score 0-3 with higher scores with worse outcome.

  72 weeks

• UW-QOL (University of Washington Quality of Life Questionnaire)

  Provides basic quality of life data on the physical, functional, emotional quality of life of the head and neck cancer patient. Score 0-100 with the higher score the better outcome.

  72 weeks

• Chronic Pain Assessment

  Assess chronic pain that changes over time, persistent baseline and breakthrough pain. This isn't scored in the same way, but the severity of pain scale 0-10 and use of medications will be compared. A higher score is worse outcome.

  72 weeks

Study Arms (1)

Research group

EXPERIMENTAL

Sleep apnea testing will be performed with this group, in the form of quality of life and sleep questionnaires, home sleep study results, as well as information collected from their electronic medical record. The investigator will also obtain blood laboratory specimens to measure serum TNF-alpha and IL-6.

Diagnostic Test: Obstructive sleep apnea testing

Interventions

Obstructive sleep apnea testing DIAGNOSTIC_TEST

* Functional Outcomes of Sleep Questionnaire (FOSQ-10) * European Organization for Research and Treatment of Cancer Head and Neck Survey (EORTC HN 35) * Epworth Sleepiness Scale (ESS) * Adult Comorbidity Evaluation (ACE 27) * University of Washington Quality of Life Questionnaire (UW-QOL) * Chronic Pain Assessment Questionnaire

Research group

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients with an established relationship with the adult Otolaryngology and/or Radiation Oncology clinic at AMC or HRH.
• Patients that present with a new diagnosis of oropharyngeal SCC who undergo radiation treatment, with or without chemotherapy.
• Patients who may require trachesotomy will be included.
• Stated willingness to comply with all study procedures and be available for the duration of the study.

You may not qualify if:

• Under the age of 21 or over the age of 90.
• Unwilling to sign the informed consent.
• Unable or unwilling to participate in sleep studies.
• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: April 20, 2021
• Primary Completion: September 28, 2022
• Study Completion: September 28, 2022
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)