Sleep and Circadian Rhythm Study in Head and Neck Cancer Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Educational Intervention; Other: Counseling; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Medical Device Usage and Evaluation

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I - BBT-CI; Patients participate in BBT-CI over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks.	Other: Questionnaire Administration; Ancillary studies; Other: Educational Intervention; Participate in BBT-CI sessions; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational
Active Comparator: Arm II- therapist; Patients meet with therapist over 60 minutes for 2 sessions and phone calls over 15 minutes once weekly for 4 weeks.	Other: Questionnaire Administration; Ancillary studies; Other: Counseling; Meet with therapist; Other Names: Counseling Intervention
Experimental: 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.	Other: Questionnaire Administration; Ancillary studies; Procedure: Biospecimen Collection; Undergo collection of cheek cell and blood samples; Other Names: Biological Sample Collection; Other: Electronic Health Record Review; Medical records are reviewed; Other: Medical Device Usage and Evaluation; Wear actigraphy watch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	Up to 1 year
Sleep Efficiency	Will be measured by using a non-invasive wrist actigraphy monitor.	Up to 1 year
Sleep Disturbance	Sleep diaries will assess sleep and wake time	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic inflammatory markers will include IL-6, IL1b and TNF.		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.	Up to 1 year

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Investigators: Principal Investigator: Fangyi Gu, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): December 15, 2021
• Primary Completion (Anticipated): December 15, 2025
• Study Completion (Anticipated): December 15, 2026

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: I 864421 (Other Identifier: Roswell Park Cancer Institute); NCI-2021-09748 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• 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