Locally Advanced Head and Neck Squamous Cell CarcinomaNCT03875053
Home Sleep Apnea Machine in Evaluating Obstructive Sleep Apnea in Patients With Stage III-IV Head and Neck Cancer
A study testing Monitoring Device, Quality-of-Life Assessment and Questionnaire Administration in people with Locally Advanced Head and Neck Squamous Cell Carcinoma and Metastatic Head and Neck Squamous Cell Carcinoma, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Monitoring Device, Quality-of-Life Assessment and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2023to 24 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
About this study
Official title: Evaluation of Obstructive Sleep Apnea in Head and Neck Cancer
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.
Read the detailed 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.
- Conditions
- Locally Advanced Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma
- Being tested
- Monitoring Device, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring DeviceDiagnostic test
Also called Monitor
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.
Quality-of-Life AssessmentOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Monitoring device, Quality of Life Assessment, Questionnaire | Experimental | 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. Receives: Diagnostic Test: Monitoring Device; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Secondary outcomes (3)
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start25 Jul 2023 (estimated)
- Primary completion24 Aug 2023 (estimated)
- Study completion24 Aug 2024 (estimated)
Why it stopped: No accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ammar Sukari, Barbara Ann Karmanos Cancer Institute
- Investigators
- Ammar Sukari, M.D., Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875053
- Sponsor's protocol ID
- 2017-135
- Other IDs
- P30CA022453
- Status last verified
- Oct 2023
- First submitted
- 11 Feb 2019
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Obstructive Sleep Apnea in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03875053
- Acronym / sponsor ID
- 2017-135
- Conditions
- Locally Advanced Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Jul 2023 (estimated)
- Primary completion
- 24 Aug 2023 (estimated)
- Study completion
- 24 Aug 2024 (estimated)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monitoring device, Quality of Life Assessment, Questionnaire | Experimental | Diagnostic Test: Monitoring Device, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monitoring DeviceAlso: MonitorPatients 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, Quality of Life Assessment, Questionnaire |
| Quality-of-Life AssessmentAncillary studies | Other | Monitoring device, Quality of Life Assessment, Questionnaire |
| Questionnaire AdministrationAncillary studies | Other | Monitoring device, Quality of Life Assessment, Questionnaire |
Primary outcome
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.
3 secondary outcomes
Response to CRT
Time frame: Up to 1 year
Occurrence of OSA in stage III-IVb patients undergoing CRT
Time frame: Up to 1 year
OSA rate in locally advanced or metastatic stage head and neck squamous cell carcinoma (HNSCC) patients
Time frame: Up to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ammar Sukari, M.D. principal investigator
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring Device, Quality-of-Life Assessment and Questionnaire Administration in people with Locally Advanced Head and Neck Squamous Cell Carcinoma and Metastatic Head and Neck Squamous Cell Carcinoma, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obstructive sleep apnea (OSA) rate before and after chemoradiation therapy (CRT) in stage III-IVb patients undergoing CRT (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.