A Study of Neurocognitive Tests and Questionnaires for People With Head and Neck Cancer Who Are Undergoing Radiation Therapy

Head and Neck Cancer Clinical Trial

Official title:

Pilot Study of Radiation-Associated Neurocognitive Function Among Head and Neck Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05207098
• Other study ID #: 21-498
• Status: Active, not recruiting
• Start date: December 22, 2021
• Est. completion date: December 2026

Study information

• Verified date: November 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The researchers are doing this study to collect more information about if, and how, neurocognitive function may be affected in people being treated with radiation therapy for head and neck cancer. Part of this study is to see if patients diagnosed with head and neck cancer who are undergoing radiation therapy are able to complete neurocognitive testing and questionnaires at 3 times over a period of 1 year.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Pathologically proven diagnosis of a head and neck cancer, specifically these subtypes: nasopharynx, maxillary sinus, tonsil, base of the tongue, oral cavity, or larynx/hypopharynx, oropharynx, cancer of unknown primary, or salivary gland.

• Ages = 18 and <89 at time of diagnosis.

• Recently diagnosed with their initial head and neck cancer and able to be consented prior to OR within first week of starting standard of care radiation therapy.

• Baseline simulation whole-brain MRI or CT available as part of standard of care.

• Patients diagnosed with cancer, no distant metastases.

• Karnofsky Performance Status of >= 70 or comparable ECOG performance at enrollment.

• As per self-report, if currently taking psychoactive medications (excluding gabapentin and including but not limited to antidepressants, and anxiolytics) on a daily basis, dose must have been stable for at least two months prior to enrollment.

• English fluent as per self-reported fluency of "well' or "very well", and having a reasonable comprehension of the study conversation in the opinion of the research staff).** ** Language verification: Prior to enrollment, all patients will be asked the following two questions by the CRC to verify English fluency necessary for participation in the study:

1. How well do you speak English?

Must respond "Well" or "Very well" when given the choices of:

Very well, Well, Not well, Not at all, Don't know, or Refused.

2. What is your preferred language for healthcare? Must respond English.

Exclusion Criteria:

• Patients with multiple primary head and neck cancers, carcinoma of unknown primary, or recurrence.

• Patients who previously received radiation therapy to the head and neck region as treatment for any prior cancer for any other non-cancerous condition.

• Patients who had chemotherapy within two years prior to their recent diagnosis of head and neck cancer, such as patients who received chemotherapy as treatment for any other type of cancer or received neoadjuvant chemotherapy prior to surgery to treat their recent head and neck diagnosis. Patients who receive induction chemotherapy just prior to the start of their radiation therapy or receive concurrent chemotherapy to treat their recent head and neck diagnosis are allowed

• At the discretion of the clinician, patients who are unable to comfortably speak due to symptoms of their cancer or treatment, such as surgery.

• Pre-existing diagnosis of neurodegenerative disorder that affects cognitive function (e.g. Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, Dementia, Seizure Disorders, etc.).

• As per medical record or self-report, history of stroke or head injury requiring medical care, confirmed structural lesion on neuroimaging, and persistent cognitive difficulties impacting work or daily life or required cognitive rehabilitation.

• Pre-existing diagnosis of a Schizophrenia Spectrum Disorder, substance use disorder, Bipolar Disorder or Schizotypal personality disorder. Schizophrenia Spectrum Disorders include Schizophrenia, Schizophreniform disorder, Schizoaffective disorder, Delusional disorder, Brief psychotic disorder, and Attenuated Psychotic Disorder.

• Pre-existing visual or auditory impairment that would preclude ability to complete the assessments (e.g. history of significant macular degeneration or being unable to correct hearing with hearing aids)

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Neurocognitive Tests
Baseline only: WRAT Reading Test, WMS-IV Logical Memory Subtest, Hopkins Verbal Learning Test (HVLT), Oral Trailmaking - Part A and B, NAB Digit Span, Category Fluency Test, Oral Symbol Digit Modalities Test, Brief Test of Attention, FAS - Controlled Oral Word Association Test (COWAT), Verbal Naming, Enformia Cogsuite Battery
• Questionnaires
Sociodemographics, Computerized Cognitive Training Programs Questionnaire, CDC Behavioral Risk Factor (Smoking Assessment), Alcohol Consumption CDC, Current Health Rating (KPS), OARS Physical Health section, COVID Medical History, Hospital Anxiety and Depression Scale (HADS), Fatigue Symptom Inventory (FSI), Functional Assessment of Cancer Therapy-General (FACT-G V4), Functional Assessment of Cancer Therapy-Cognition (FACT-Cog V3), Sensory Gating Inventory (SGI)

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Limited Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of newly diagnosed head and neck cancer patients recruited and retained on study	have complete the neurocognitive testing	1 year

External Links

•   Memorial Sloan Kettering Cancer Center