Clinical trial NCT05186948: Development and Validation of a Novel Functional Eye-Tracking Software Application for Cancer-related Cognitive Impairment (CRCI)
Official title: Development and Validation of a Novel Functional Eye-Tracking Software Application for Cancer-related Cognitive Impairment (CRCI)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer-related Cognitive Impairment
Keywords: Cancer-related cognitive impairment (CRCI)
Eye Movement Biomarkers
Eye-tracking
Lead sponsor: Innodem Neurosciences
Sponsor class: INDUSTRY
First posted: 2022-01-11
Enrollment: 230
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Data will be obtained from 200 patients with an initial diagnosis of breast cancer stages I-IIIA and scheduled chemotherapy, fulfilling the eligibility criteria. Data will also be acquired from a group of 30 healthy control participants. Groups will be matched for age and sex.

Brief summary: This study aims to develop and validate a sensitive and non-invasive eye-tracking software application.

Detailed description: This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by the Cancer-related cognitive impairment (CRCI) and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. The study data will be used to develop machine learning algorithms and validate a software application intended to track the progressive component of the Cancer-related cognitive impairment (CRCI) and associated cognitive changes.

Eligibility criteria: Inclusion Criteria:

* For all participants:

  1. Able to provide informed consent.
  2. Visual acuity sufficient to be able to read the consent form with corrective lenses.
  3. Over 18 years of age.
  4. English- or French-speaking.
* For patients only:

  1. Initial diagnosis of breast cancer stage I-IIIA and scheduled chemotherapy
  2. First-time cancer diagnosis.
  3. ECOG performance \< 2
  4. Receiving curative intent chemotherapy: either Adriamycin/Cyclophosphamide for 4 cycles followed by weekly Taxol for 12 cycles or Taxotere/Cyclophosphamide for 4 cycles

Exclusion Criteria:

* For all participants:

  1. Evidence or medical history of neurological/psychiatric issues known to affect movements and oculomotor control.
  2. Presence of comorbid neurological conditions to avoid eye movement anomaly confounds (Strabismus, cranial nerve palsy, stroke-causing hemianopsia).
  3. Diagnosis of macular edema or other pre-existing ocular conditions that would prevent participants from performing the eye movement assessments.
  4. Previous history of cancer or chemotherapy
  5. Distant metastases
  6. Recent (less than three months from enrollment) start of, change of dose, or irregular use of, new prescription drugs known to influence ocular motor visual function, such as benzodiazepines, antipsychotics and anticonvulsants. Occasional use of benzodiazepines for medical procedures is permitted, at the investigator's discretion, but should not occur within a short time period prior to or during an eye movement assessment.
  7. Diagnosis of a substance abuse disorder.
  8. Recreational drug use (e.g., alcohol, marijuana) is a potential exclusion criterion that will be determined on an individual basis as per the discretion of the research team. All recreational drug use will be documented.

Primary outcomes:
measure: Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 36
timeFrame: Baseline and Month 36
Secondary outcomes:
measure: Change from Baseline in The Controlled Oral Word Association Test (COWAT) scores at Month 36
timeFrame: Baseline and Month 36
measure: Change from Baseline in The Trail Making Test (TMT) Parts A & B scores at Month 36
timeFrame: Baseline and Month 36
measure: Change from Baseline in The Hopkins Verbal Learning Test-Revised (HVLT-R) scores at Month 36
timeFrame: Baseline and Month 36
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill University Health Center-Cedar Cancer Center
state: Quebec
Study officials:
References: