Recruiting

Radiation Therapy

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05207098

Conditions

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Neurocognitive Tests

Questionnaires

Study Details

Brief 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.

Conditions

Head and Neck Cancer

Study ID

NCT05207098

Start date

Dec 22, 2021

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Neurocognitive Tests and Questionnaires

The performance-based measures will be administered with a total completion time estimated to be 90 minutes. The neurocognitive battery is similar in content and duration to multiple previous and ongoing studies being conducted by the Neurocognitive Research Lab.

Interventions

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)

Primary outcome measure

  • Number of newly diagnosed head and neck cancer patients recruited and retained on study [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Jonine Bernstein, PhD

646-888-8241bernstej@mskcc.org

Lawrence Dauer, PhD

212-639-5372

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Jonine Bernstein, PhD

646-888-8241

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Jonine Bernstein, MD

646-888-8241

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Jonine Bernstein, PhD

646-888-8241

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Jonine Bernstein, PhD

646-888-8241

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Jonine Bernstein, PhD

646-888-8241

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Jonine Bernstein, PhD

646-888-8241

Lawrence Dauer, PhD

212-639-5372

Principal Investigator:

Jonine Bernstein, PhD

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Jonine Bernstein, PhD

646-888-8241

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Keywords

  • Neurocognitive function
  • Neurocognitive Tests
  • Questionnaires
  • 21-498

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-06-05.