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

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ClinicalTrials.gov Identifier: NCT03875053
Recruitment Status : Not yet recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Misako Nagasaka, Barbara Ann Karmanos Cancer Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Head and Neck Squamous Cell Carcinoma Metastatic Head and Neck Squamous Cell Carcinoma Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8 Diagnostic Test: Monitoring Device Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Obstructive Sleep Apnea in Head and Neck Cancer
Estimated Study Start Date : March 20, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2019


Arm Intervention/treatment
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.
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 Name: Monitor

Other: Quality-of-Life Assessment
Ancillary studies

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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 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.

  3. 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.


Other Outcome Measures:
  1. Adherence rate to OSA treatment to 30 days [ Time Frame: Up to 1 year ]
    It is defined as the ratio of the number of days adhered to OSA treatment to 30 days.

  2. Incidence rate of OSA by MRI neck findings [ Time Frame: Up to 1 year ]
    It is the OSA rate detected by MRI neck findings among oropharyngeal cancer patients.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875053


Contacts
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Contact: Misako Nagasaka, M.D. 313-576-8753 nagasakm@karmanos.org

Locations
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United States, Michigan
Barbara Ann Karmanos Cancer Institute Not yet recruiting
Detroit, Michigan, United States, 48201
Contact    800-527-6266      
Principal Investigator: Misako Nagasaka, M.D.         
Sub-Investigator: Harold Kim, M.D.         
Sub-Investigator: Ho-Sheng Lin, M.D.         
Sub-Investigator: Abdulghani Sankari, M.D. Ph.D.         
Sub-Investigator: Richard Schwab, M.D.         
Sub-Investigator: George Yoo, M.D.         
Sub-Investigator: Ammar Sukari, M.D.         
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Misako Nagasaka, M.D. Barbara Ann Karmanos Cancer Institute

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Responsible Party: Misako Nagasaka, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT03875053     History of Changes
Other Study ID Numbers: 2017-135
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neoplasms by Site