NCT05099952

Sleep and Circadian Rhythm Study in Head and Neck Cancer Patients

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of cheek cell and blood samples
OTHER	Counseling	Meet with therapist
OTHER	Educational Intervention	Participate in BBT-CI sessions
OTHER	Electronic Health Record Review	Medical records are reviewed
OTHER	Medical Device Usage and Evaluation	Wear actigraphy watch
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2021-12-15
• Primary completion: 2025-12-15
• Completion: 2026-12-15
• First posted: 2021-10-29
• Last updated: 2022-01-12

Locations

1 site across 1 country: United States