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Sleep and Circadian Rhythm Study in Head and Neck Cancer Patients

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biospecimen Collection
Counseling
Educational Intervention
Electronic Health Record Review
Medical Device Usage and Evaluation
Questionnaire Administration
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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)
  • 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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Arm I - BBT-CI

Arm II- therapist

Observational Study

Arm Description

Patients participate in BBT-CI over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks.

Patients meet with therapist over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks.

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.

Outcomes

Primary Outcome Measures

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).
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.
Insomnia Severity Index (ISI)
A brief questionnaire where the total responses are added up with higher scores indicating more acute symptoms of insomnia.
Sleep Efficiency
Will be measured by using a non-invasive wrist actigraphy monitor.
Sleep Disturbance
Sleep diaries will assess sleep and wake time

Secondary Outcome Measures

Systemic inflammatory markers will include IL-6, IL1b and TNF.
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.

Full Information

First Posted
September 29, 2021
Last Updated
December 22, 2021
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05099952
Brief Title
Sleep and Circadian Rhythm Study in Head and Neck Cancer Patients
Official Title
Sleep and Circadian Rhythm Study in Head and Neck Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Withdrawn
Why Stopped
PI left institute-no accruals
Study Start Date
December 15, 2021 (Anticipated)
Primary Completion Date
December 15, 2025 (Anticipated)
Study Completion Date
December 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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: I. 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: I. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I - BBT-CI
Arm Type
Experimental
Arm Description
Patients participate in BBT-CI over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks.
Arm Title
Arm II- therapist
Arm Type
Active Comparator
Arm Description
Patients meet with therapist over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks.
Arm Title
Observational Study
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection
Intervention Description
Undergo collection of cheek cell and blood samples
Intervention Type
Other
Intervention Name(s)
Counseling
Other Intervention Name(s)
Counseling Intervention
Intervention Description
Meet with therapist
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Participate in BBT-CI sessions
Intervention Type
Other
Intervention Name(s)
Electronic Health Record Review
Intervention Description
Medical records are reviewed
Intervention Type
Other
Intervention Name(s)
Medical Device Usage and Evaluation
Intervention Description
Wear actigraphy watch
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Development of oral mucositis (OM)
Description
OM is assessed weekly during treatment by clinical exam and patient reported Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (OMWQ-HN).
Time Frame
Up to 1 year
Title
Self-reported oral mucositis pain
Description
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.
Time Frame
Up to 1 year
Title
Insomnia Severity Index (ISI)
Description
A brief questionnaire where the total responses are added up with higher scores indicating more acute symptoms of insomnia.
Time Frame
Up to 1 year
Title
Sleep Efficiency
Description
Will be measured by using a non-invasive wrist actigraphy monitor.
Time Frame
Up to 1 year
Title
Sleep Disturbance
Description
Sleep diaries will assess sleep and wake time
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Systemic inflammatory markers will include IL-6, IL1b and TNF.
Time Frame
Up to 1 year
Title
Correlation of sleep measurement with total opioid use
Description
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.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fangyi Gu
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Sleep and Circadian Rhythm Study in Head and Neck Cancer Patients

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