Development and Validation of a Novel Functional Eye-Tracking Software Application for Cancer-related Cognitive Impairment (CRCI)

Innodem Neurosciences

Status: Enrolling

Conditions: Cancer-related Cognitive Impairment

Treatments: Device: Eye-Tracking

Study type: Observational

Funder types: Industry

Identifiers

NCT05186948

ETNA-CRCI

Details and patient eligibility

About

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

Full 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.

Enrollment: 230 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

230 participants in 2 patient groups

Breast cancer patients (stages I-IIIA)

Description:

200 patients with an initial diagnosis of breast cancer stages I-IIIA and scheduled chemotherapy, fulfilling the eligibility criteria

Treatment:

Device: Eye-Tracking

healthy control

Description:

Group of 30 healthy control participants, matched for age and sex, with no evidence or history of significant neurodegenerative disorder affecting brain function.

Treatment:

Device: Eye-Tracking