Head and Neck Squamous Cell CarcinomaNCT05099952
Sleep and Circadian Rhythm Study in Head and Neck Cancer Patients
A study testing Biospecimen Collection, Counseling and Educational Intervention in people with Head and Neck Squamous Cell Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This clinical trial studies the effect and underlying mechanisms of sleep and circadian rhythm factors on oral mucositis pain in head and neck cancer patients treated by chemoradiotherapy. Poor sleep may have a correlation to increased pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Biospecimen Collection, Counseling and Educational Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2021to 15 Dec 2026
- 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
- Patients with histologically confirmed head and neck squamous cell carcinoma who have a CRT treatment scheduled at Roswell Park
- Age >= 18 years of age
- Able to read, comprehend and speak the English language
- Willing to wear a wristwatch (actiwatch) and complete the sleep log to monitor sleep and activity for three weeks (Week 1, 3, and 6) during CRT
- Willing to wear the ApneaLink Air at-home sleep monitor for one night at baseline (pre-CRT)
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
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- Willing to provide biospecimen samples (saliva, cheek cells, and blood) twice during CRT (week 1 and week 4) and optional for week 6
- ADDITIONAL INTERVENTIONAL STUDY CRITERIA
- Insomnia Severity Index (ISI) total score >= 7
- Willing to complete a course of Brief Behavioral Therapy for Insomnia (BBT-CI) during the treatment weeks
Who cannot join
- Participant does not meet the overall Inclusion Criteria for this study
- Patients who developed severe oral mucositis with World Health Organization Scale III or above with ulcers on the cheeks
- ADDITIONAL INTERVENTION STUDY (BBT-CI): Currently receiving treatment for insomnia or other sleep disorders
- ADDITIONAL INTERVENTION STUDY (BBT-CI): History of severe mental illness
- ADDITIONAL INTERVENTION STUDY (BBT-CI): Attending behavioral intervention programs for smoking cessation or other substance use disorders
- ADDITIONAL INTERVENTION STUDY (BBT-CI): Shift workers or persons with a known sleep disorder affecting regular sleep phase initiation (e.g. sleep onset outside the 9 pm- 12 am hours)
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- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the participant an unsuitable candidate for study participation
- Cognitively impaired adults/adults with impaired decision-making capacity, individuals who are not yet adults (infants, children, and teenagers), pregnant women, and prisoners are all excluded from this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
This clinical trial studies the effect and underlying mechanisms of sleep and circadian rhythm factors on oral mucositis pain in head and neck cancer patients treated by chemoradiotherapy. Poor sleep may have a correlation to increased pain. A behavioral intervention, Brief Behavioral Therapy for Cancer related Insomnia, may improve patients' sleep and may also reduce oral mucositis pain.
Read the detailed description
PRIMARY OBJECTIVES:
- To examine the effect and underlying mechanisms of sleep and circadian rhythm factors on oral mucositis pain in head and neck cancer patients treated by chemoradiotherapy.
Ia. To assess the impact of chemo-radiotherapy (CRT) on the onset and duration of sleep disturbance in head and neck carcinoma (HNC) patients, and identify factors that trigger or aggravate sleep disturbance.
Ib. To examine the effect of the association between sleep and CRT-induced oral mucositis (OM) pain.
SECONDARY OBJECTIVE:
- To examine the pathways by which sleep disturbance may aggravate radiation-induced OM pain.
OUTLINE:
OBSERVATIONAL STUDY: Patients wear actigraphy watch and complete sleep log at baseline (over the weekend prior to first day of CRT), and weeks 1, 3, and 6 during treatment. Patients also undergo collection of cheek cell samples and may undergo collection of blood samples at weeks 1, 3 and 6 during treatment. Patients' medical records are also reviewed.
INTERVENTION STUDY: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in BBT-CI over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks.
ARM II: Patients meet with therapist over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks.
After completion of study, patients are followed up at 1, 3, 6, and 12 months.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Biospecimen Collection, Counseling, Educational Intervention, Electronic Health Record Review, Medical Device Usage and Evaluation
- 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.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection
Undergo collection of cheek cell and blood samples
CounselingOther
Also called Counseling Intervention
Meet with therapist
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Participate in BBT-CI sessions
Electronic Health Record ReviewOther
Medical records are reviewed
Medical Device Usage and EvaluationOther
Wear actigraphy watch
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I - BBT-CI | Experimental | Patients participate in BBT-CI over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks. Receives: Other: Educational Intervention; Other: Questionnaire Administration |
| Arm II- therapist | Active comparator | Patients meet with therapist over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks. Receives: Other: Counseling; Other: Questionnaire Administration |
| Observational Study | Experimental | Patients wear actigraphy watch and complete sleep log at baseline (over the weekend prior to first day of CRT), and weeks 1, 3, and 6 during treatment. Patients also undergo collection of cheek cell samples and may undergo collection of blood samples at weeks 1, 3 and 6 during treatment. Patients' medical records are also reviewed. Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of oral mucositis (OM)
OM is assessed weekly during treatment by clinical exam and patient reported Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (OMWQ-HN).
Measured: Up to 1 year
Self-reported oral mucositis pain
OM pain is assessed using a visual analog scale that rates patients' overall mouth and throat soreness, on a scale of 0-10, weekly during CRT and after chemoradiotherapy (CRT) up to one year at follow up visits.
Measured: Up to 1 year
Insomnia Severity Index (ISI)
A brief questionnaire where the total responses are added up with higher scores indicating more acute symptoms of insomnia.
Measured: Up to 1 year
Sleep Efficiency
Will be measured by using a non-invasive wrist actigraphy monitor.
Measured: Up to 1 year
Sleep Disturbance
Sleep diaries will assess sleep and wake time
Measured: Up to 1 year
Secondary outcomes (2)
Systemic inflammatory markers will include IL-6, IL1b and TNF.
Measured: Up to 1 year
Correlation of sleep measurement with total opioid use
Opioids are carefully prescribed as standard of care during CRT according to the severity of pain. Total opioid use, summarized by morphine milligram equivalents, will therefore also be assessed as a surrogate for overall pain severity.
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 posted29 Oct 2021
- Study start15 Dec 2021 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2026 (estimated)
Why it stopped: PI left institute-no accruals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fangyi Gu, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099952
- Sponsor's protocol ID
- I 864421
- Other IDs
- NCI-2021-09748, I 864421
- Status last verified
- Dec 2021
- First submitted
- 29 Sep 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Circadian Rhythm Study in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT05099952
- Acronym / sponsor ID
- I 864421
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institute-no accruals
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 15 Dec 2021 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 29 Oct 2021 (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 clinical trial studies the effect and underlying mechanisms of sleep and circadian rhythm factors on oral mucositis pain in head and neck cancer patients treated by chemoradiotherapy. Poor sleep may have a correlation to increased pain. A behavioral intervention, Brief Behavioral Therapy for Cancer related Insomnia, may improve patients' sleep and may also reduce oral mucositis pain.
Detailed description
PRIMARY OBJECTIVES:
- To examine the effect and underlying mechanisms of sleep and circadian rhythm factors on oral mucositis pain in head and neck cancer patients treated by chemoradiotherapy.
Ia. To assess the impact of chemo-radiotherapy (CRT) on the onset and duration of sleep disturbance in head and neck carcinoma (HNC) patients, and identify factors that trigger or aggravate sleep disturbance.
Ib. To examine the effect of the association between sleep and CRT-induced oral mucositis (OM) pain.
SECONDARY OBJECTIVE:
- To examine the pathways by which sleep disturbance may aggravate radiation-induced OM pain.
OUTLINE:
OBSERVATIONAL STUDY: Patients wear actigraphy watch and complete sleep log at baseline (over the weekend prior to first day of CRT), and weeks 1, 3, and 6 during treatment. Patients also undergo collection of cheek cell samples and may undergo collection of blood samples at weeks 1, 3 and 6 during treatment. Patients' medical records are also reviewed.
INTERVENTION STUDY: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in BBT-CI over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks.
ARM II: Patients meet with therapist over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks.
After completion of study, patients are followed up at 1, 3, 6, and 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I - BBT-CI | Experimental | Other: Educational Intervention, Other: Questionnaire AdministrationPatients participate in BBT-CI over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks. |
| Arm II- therapist | Active comparator | Other: Counseling, Other: Questionnaire AdministrationPatients meet with therapist over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks. |
| Observational Study | Experimental | Procedure: Biospecimen Collection, Other: Electronic Health Record Review, Other: Medical Device Usage and Evaluation, Other: Questionnaire AdministrationPatients wear actigraphy watch and complete sleep log at baseline (over the weekend prior to first day of CRT), and weeks 1, 3, and 6 during treatment. Patients also undergo collection of cheek cell samples and may undergo collection of blood samples at weeks 1, 3 and 6 during treatment. Patients' medical records are also reviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with histologically confirmed head and neck squamous cell carcinoma who have a CRT treatment scheduled at Roswell Park
- Age >= 18 years of age
- Able to read, comprehend and speak the English language
- Willing to wear a wristwatch (actiwatch) and complete the sleep log to monitor sleep and activity for three weeks (Week 1, 3, and 6) during CRT
- Willing to wear the ApneaLink Air at-home sleep monitor for one night at baseline (pre-CRT)
Key exclusion criteria (9 listed)
- Participant does not meet the overall Inclusion Criteria for this study
- Patients who developed severe oral mucositis with World Health Organization Scale III or above with ulcers on the cheeks
- ADDITIONAL INTERVENTION STUDY (BBT-CI): Currently receiving treatment for insomnia or other sleep disorders
- ADDITIONAL INTERVENTION STUDY (BBT-CI): History of severe mental illness
- ADDITIONAL INTERVENTION STUDY (BBT-CI): Attending behavioral intervention programs for smoking cessation or other substance use disorders
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 |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample CollectionUndergo collection of cheek cell and blood samples | Procedure or surgery | Observational Study |
| CounselingAlso: Counseling InterventionMeet with therapist | Other | Arm II- therapist |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalParticipate in BBT-CI sessions | Other | Arm I - BBT-CI |
| Electronic Health Record ReviewMedical records are reviewed | Other | Observational Study |
| Medical Device Usage and EvaluationWear actigraphy watch | Other | Observational Study |
| Questionnaire AdministrationAncillary studies | Other | Arm I - BBT-CI, Arm II- therapist, Observational Study |
Primary outcome
Development of oral mucositis (OM)
Time frame: Up to 1 year
OM is assessed weekly during treatment by clinical exam and patient reported Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (OMWQ-HN).
Self-reported oral mucositis pain
Time frame: Up to 1 year
OM pain is assessed using a visual analog scale that rates patients' overall mouth and throat soreness, on a scale of 0-10, weekly during CRT and after chemoradiotherapy (CRT) up to one year at follow up visits.
Insomnia Severity Index (ISI)
Time frame: Up to 1 year
A brief questionnaire where the total responses are added up with higher scores indicating more acute symptoms of insomnia.
Sleep Efficiency
Time frame: Up to 1 year
Will be measured by using a non-invasive wrist actigraphy monitor.
Sleep Disturbance
Time frame: Up to 1 year
Sleep diaries will assess sleep and wake time
2 secondary outcomes
Systemic inflammatory markers will include IL-6, IL1b and TNF.
Time frame: Up to 1 year
Correlation of sleep measurement with total opioid use
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 12 Jan 2022.
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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.
Fangyi Gu principal investigator
Roswell Park 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 Biospecimen Collection, Counseling and Educational Intervention in people with Head and Neck Squamous Cell Carcinoma, run by Roswell Park 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 10 inclusion and 9 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 12 Jan 2022. 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?
Development of oral mucositis (OM) (time frame: Up to 1 year). The study lists 5 primary outcomes in all. 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 12 Jan 2022.