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Withdrawn NA INTERVENTIONAL NCT05099952

Sleep and Circadian Rhythm Study in Head and Neck Cancer Patients

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

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

Primary Outcomes

Measure: Development of oral mucositis (OM)
TimeFrame: Up to 1 year
Description: OM is assessed weekly during treatment by clinical exam and patient reported Oral Mucositis Weekly Questionnaire-Head and Neck Cancer (OMWQ-HN).
Measure: Self-reported oral mucositis pain
TimeFrame: Up to 1 year
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.
Measure: Insomnia Severity Index (ISI)
TimeFrame: Up to 1 year
Description: A brief questionnaire where the total responses are added up with higher scores indicating more acute symptoms of insomnia.
Measure: Sleep Efficiency
TimeFrame: Up to 1 year
Description: Will be measured by using a non-invasive wrist actigraphy monitor.
Measure: Sleep Disturbance
TimeFrame: Up to 1 year
Description: Sleep diaries will assess sleep and wake time

Trial Information

NCT ID

NCT05099952

Status

Withdrawn

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Roswell Park Cancer Institute

Last Updated

December 15, 2025