Status:
UNKNOWN
Development and Validation of a Novel Functional Eye-Tracking Software Application for Cancer-related Cognitive Impairment (CRCI)
Lead Sponsor:
Innodem Neurosciences
Conditions:
Cancer-related Cognitive Impairment
Eligibility:
FEMALE
18+ years
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...
Eligibility Criteria
Inclusion
- For all participants:
- Able to provide informed consent.
- Visual acuity sufficient to be able to read the consent form with corrective lenses.
- Over 18 years of age.
- English- or French-speaking.
- For patients only:
- Initial diagnosis of breast cancer stage I-IIIA and scheduled chemotherapy
- First-time cancer diagnosis.
- ECOG performance \< 2
- Receiving curative intent chemotherapy: either Adriamycin/Cyclophosphamide for 4 cycles followed by weekly Taxol for 12 cycles or Taxotere/Cyclophosphamide for 4 cycles
Exclusion
- For all participants:
- Evidence or medical history of neurological/psychiatric issues known to affect movements and oculomotor control.
- Presence of comorbid neurological conditions to avoid eye movement anomaly confounds (Strabismus, cranial nerve palsy, stroke-causing hemianopsia).
- Diagnosis of macular edema or other pre-existing ocular conditions that would prevent participants from performing the eye movement assessments.
- Previous history of cancer or chemotherapy
- Distant metastases
- 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.
- Diagnosis of a substance abuse disorder.
- 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.
Key Trial Info
Start Date :
March 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 20 2025
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT05186948
Start Date
March 30 2022
End Date
January 20 2025
Last Update
October 18 2023
Active Locations (1)
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1
McGill University Health Center-Cedar Cancer Center
Montreal, Quebec, Canada, H4A 3J1