Home Sleep Apnea Machine in Evaluating Obstructive Sleep Apnea in Patients With Stage III-IV Head and Neck Cancer

Overview

This trial studies information from a home sleep apnea machine to evaluate obstructive sleep apnea in patients with stage III-IV head and neck cancer. Sleep apnea (trouble breathing during sleep) can occur in head and neck cancer patients who have swelling in their neck. Wearing a sleep apnea machine overnight may help doctors evaluate obstructive sleep apnea in patients with head and neck cancer.

Full Title of Study: “Evaluation of Obstructive Sleep Apnea in Head and Neck Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 30, 2019

Interventions

  • Diagnostic Test: Monitoring Device
    • Patients wear the home sleep apnea machine overnight. Patients undergoing standard of care CRT wear the home sleep apnea machine a second time 3 months after completion of CRT.
  • Other: Quality-of-Life Assessment
    • Ancillary studies
  • Other: Questionnaire Administration
    • Ancillary studies

Arms, Groups and Cohorts

  • Experimental: Monitoring device, Quality of Life Assessment, Questionnaire
    • Patients wear the home sleep apnea machine overnight. Patients undergoing standard of care CRT wear the home sleep apnea machine a second time 3 months after completion of CRT.

Clinical Trial Outcome Measures

Primary Measures

  • Obstructive sleep apnea (OSA) rate before and after chemoradiation therapy (CRT) in stage III-IVb patients undergoing CRT
    • Time Frame: Up to 1 year
    • The definition of OSA will be defined as apnea-hypopnea index of > 5 for both pre and post CRT. The OSA rate is the proportion of patients diagnosed with OSA. Will be assessed using a two-sided McNemar test based on the OSA occurrence (Yes versus [vs.] No) for each patient. The OSA rates pre and post CRT will be described by means and their two-sided confidence intervals (Cls). The univariable and multivariable conditional logistic regression models will be further used for the primary objective with patients’ baseline characteristics as covariates.

Secondary Measures

  • Response to CRT
    • Time Frame: Up to 1 year
    • Will be evaluated using Response Evaluation Criteria in Solid Tumors version 1.1. Will be described by mean and the two-sided CI. The univariable and multivariable binary (multinomial) logistic regression models will be used to assess the association of the effects of patients’ baseline characteristics and the occurrence of OSA on the CRT responses.
  • Occurrence of OSA in stage III-IVb patients undergoing CRT
    • Time Frame: Up to 1 year
    • Will be grouped into four categories (Yes/Yes, Yes/No, No/Yes, and No/No for pre/post CRT). Then a 2×4 contingency table will be generated by CRT response (binary; Yes vs. No) and OSA occurrence (quaternary; Yes/Yes vs. Yes/No vs. No/Yes vs. No/No) and a Chi- 23 squared test (or Fisher’s exact test) will be used. The univariable and multivariable binary (multinomial) logistic regression models will be used to assess the association of the effects of patients’ baseline characteristics and the occurrence of OSA on the CRT responses.
  • OSA rate in locally advanced or metastatic stage head and neck squamous cell carcinoma (HNSCC) patients
    • Time Frame: Up to 1 year
    • A descriptive analysis will be performed on all patients enrolled and on all eligible patients who undergo home sleep apnea study to evaluate the OSA rate in locally advanced or metastatic stage HNSCC patients. The OSA rate will be estimated for locally advanced or metastatic stage HNSCC patients who enter the study in Part 1 and then will be described by mean and the two-sided Cl.

Participating in This Clinical Trial

Inclusion Criteria

  • Locally advanced (stage III-IVb) and metastatic (stage IVc) HNSCC who are referred to medical oncology. Patients may not have received upfront definitive surgical resection of the primary tumor or upfront neck dissection.
  • Patients must be able to operate the home sleep study device.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Exclusion Criteria

  • Patients should not have received any prior systemic chemotherapy or radiation therapy for locally advanced or metastatic HNSCC.
  • Patients with tracheostomy or those requiring the assistance of a ventilator will be ineligible for the study.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Barbara Ann Karmanos Cancer Institute
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Misako Nagasaka, Principal Investigator – Barbara Ann Karmanos Cancer Institute
  • Overall Official(s)
    • Misako Nagasaka, M.D., Principal Investigator, Barbara Ann Karmanos Cancer Institute
  • Overall Contact(s)
    • Misako Nagasaka, M.D., 313-576-8753, nagasakm@karmanos.org

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