An interventional study of Biospecimen Collection and Counseling in Head and Neck Squamous Cell Carcinoma, sponsored by Roswell Park Cancer Institute. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-12.
Sponsored by Roswell Park Cancer Institute · Not applicable, Interventional, and Supportive care
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.
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
Browse Head and Neck Neoplasms studies →Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
Undergo collection of cheek cell and blood samples
Also known as: Biological Sample Collection
Meet with therapist
Also known as: Counseling Intervention
Participate in BBT-CI sessions
Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Medical records are reviewed
Wear actigraphy watch
Ancillary studies
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).
Time frame: 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.
Time frame: 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.
Time frame: Up to 1 year
Sleep Efficiency
Will be measured by using a non-invasive wrist actigraphy monitor.
Time frame: Up to 1 year
Sleep Disturbance
Sleep diaries will assess sleep and wake time
Time frame: Up to 1 year
Systemic inflammatory markers will include IL-6, IL1b and TNF.
Time frame: 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.
Time frame: Up to 1 year
This study is withdrawn, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Roswell Park Cancer Institute