Clinical trial NCT05207098: A Study of Neurocognitive Tests and Questionnaires for People With Head and Neck Cancer Who Are Undergoing Radiation Therapy
Official title: Pilot Study of Radiation-Associated Neurocognitive Function Among Head and Neck Cancer Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Head and Neck Cancer
Keywords: Neurocognitive function
Neurocognitive Tests
Questionnaires
21-498
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSK patients at any location, diagnosed with HNC (nasopharynx, maxillary sinus, tonsil, base of the tongue, oral cavity, and larynx/hypopharynx).

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of newly diagnosed head and neck cancer patients recruited and retained on study
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jonine Bernstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: