Development of a new eye-tracking software for assessing cognitive impairment in cancer patients
Development and Validation of a Novel Functional Eye-Tracking Software Application for Cancer-related Cognitive Impairment (CRCI)
This study is testing a new eye-tracking software to see if it can help understand and monitor thinking problems in cancer patients undergoing chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 230 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Innodem Neurosciences Industry-sponsored |
| Drugs / interventions | chemotherapy, Cyclophosphamide |
| Locations | 1 site (Montréal, Quebec) |
| Trial ID | NCT05186948 on ClinicalTrials.gov |
What this trial studies
This study focuses on creating and validating a non-invasive eye-tracking software application designed to assess cognitive impairment related to cancer treatment. Participants will undergo brief cognitive tests alongside eye movement measurements in response to visual stimuli during specialized eye-tracking assessments. The collected data will be utilized to develop machine learning algorithms that can track the progression of cognitive changes associated with cancer-related cognitive impairment (CRCI). The goal is to enhance the understanding and monitoring of CRCI in patients undergoing chemotherapy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have been diagnosed with early-stage breast cancer and are scheduled to begin chemotherapy.
Not a fit: Patients with pre-existing neurological or psychiatric conditions that affect eye movement or cognitive function may not benefit from this study.
Why it matters
Potential benefit: If successful, this software could provide a sensitive tool for early detection and monitoring of cognitive impairment in cancer patients, potentially leading to better management strategies.
How similar studies have performed: While the approach of using eye-tracking for cognitive assessment is gaining interest, this specific application for cancer-related cognitive impairment is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Montréal, Quebec
- McGill University Health Center-Cedar Cancer Center — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Marianna Perna
- Email: marianna.perna@muhc.mcgill.ca
- Phone: 514-934-1934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.