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

Locally Advanced Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

Evaluation of Obstructive Sleep Apnea in Head and Neck Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03875053
• Other study ID #: 2017-135
• Secondary ID: P30CA022453
• Status: Withdrawn
• Phase: N/A
• Start date: July 25, 2023
• Est. completion date: August 24, 2024

Study information

• Verified date: October 2023
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is a single center study in HNSCC subjects to assess the effects of CRT on OSA.. Patients will be screened with a physical exam and questionnaire (The Berlin questionnaire, STOP-BANG, PSQI) and when eligible, will have the home sleep study (Specific aim 1). The low risk group (based on the physical exam and questionnaire) with stage IVc will not be eligible for the home sleep study and will concentrate on palliation of their symptoms. For locally advanced HNSCC patients undergoing definitive CRT, post CRT home sleep study results will also be assessed (Specific aim 2). When the patient is diagnosed with OSA based on the home sleep study, or if the home sleep study is negative but if the patient had high risks based on the screening process, the patient will be referred to the sleep medicine clinic. If life-threatening obstructive sleep apnea is found, the patient will be referred to sleep medicine clinic right away and will be taken off study. Otherwise, the patients will prioritize their definitive CRT for HNSCC, and will be referred to sleep medicine clinic once CRT has been completed.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 24, 2024
• Est. primary completion date: August 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Locally Advanced Head and Neck Squamous Cell Carcinoma
• Metastatic Head and Neck Squamous Cell Carcinoma
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Squamous Cell Carcinoma of Head and Neck

Intervention

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
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence rate to OSA treatment to 30 days	It is defined as the ratio of the number of days adhered to OSA treatment to 30 days.	Up to 1 year
Other	Incidence rate of OSA by MRI neck findings	It is the OSA rate detected by MRI neck findings among oropharyngeal cancer patients.	Up to 1 year
Primary	Obstructive sleep apnea (OSA) rate before and after chemoradiation therapy (CRT) in stage III-IVb patients undergoing CRT	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.	Up to 1 year
Secondary	Response to CRT	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.	Up to 1 year
Secondary	Occurrence of OSA in stage III-IVb patients undergoing CRT	Will be grouped into four categories (Yes/Yes, Yes/No, No/Yes, and No/No for pre/post CRT). Then a 2x4 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.	Up to 1 year
Secondary	OSA rate in locally advanced or metastatic stage head and neck squamous cell carcinoma (HNSCC) patients	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.	Up to 1 year