Sleep and Circadian Rhythm Study in Head and Neck Cancer Patients

NCT05099952 | Withdrawn

• 2 other identifiers: I 864421NCI-2021-09748
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

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

  Up to 1 year

• Correlation of sleep measurement with total opioid use

  Up to 1 year

Study Arms (3)

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.

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.

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.

Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of cheek cell and blood samples

Also known as: Biological Sample Collection

Observational Study

Counseling OTHER

Meet with therapist

Also known as: Counseling Intervention

Arm II- therapist

Educational Intervention OTHER

Participate in BBT-CI sessions

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm I - BBT-CI

Electronic Health Record Review OTHER

Medical records are reviewed

Observational Study

Medical Device Usage and Evaluation OTHER

Wear actigraphy watch

Observational Study

Questionnaire Administration OTHER

Ancillary studies

Arm I - BBT-CI; Arm II- therapist; Observational Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Counseling; Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Fangyi Gu

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 29, 2021
• Study Start: December 15, 2021
• Primary Completion: December 15, 2025
• Study Completion (Estimated): December 15, 2026
• Last Updated: January 12, 2022

Record last verified: 2021-12

Locations

US (1)