Development and Validation of a Novel Functional Eye-Tracking Software Application for Cancer-rel… (NCT05186948) | Clinical Trial Compass
TerminatedNot Applicable
Development and Validation of a Novel Functional Eye-Tracking Software Application for Cancer-related Cognitive Impairment (CRCI)
Stopped: Not enough personnel
Canada230 participantsStarted 2022-03-30
Plain-language summary
This study aims to develop and validate a sensitive and non-invasive eye-tracking software application.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. 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 criteria
✕. 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
What they're measuring
1
Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 36
. 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.