Impact of Targeted Therapy on Cancer-Related Cognitive Impairment

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Rochester NCORP Research Base

About this trial

This study examines whether there are differences in brain health or well-being in patients receiving TKI therapy for leukemia compared to individuals who do not receive TKI therapy.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

TKI RECIPIENTS: Participants must have a diagnosis of CML or CLL

TKI RECIPIENTS: Participants must be scheduled to receive their first dose of TKI therapy for CML or CLL within 30 days or have received their first dose of TKI therapy for CML or CLL within the previous 30 days

TKI RECIPIENTS: Participants must be ≥ 18 years of age

TKI RECIPIENTS: Participants must be able to speak and read English

Disqualifiers

Participants must have no history of metastatic cancer, primary brain tumor, or brain irradiation

Participants must have no history of TKI therapy

Participants must have no history of cytotoxic chemotherapy, immune checkpoint inhibitor therapy, hormonal therapy, biologic therapy, radiotherapy within the past 5 years. However, permitted treatments include prior use of hydroxyurea for the treatment of CML or CLL as well as treatment with obinutuzumab or rituximab concurrent with TKI therapy for CLL

Participants must have no history of stroke within the past year and no remaining cognitive symptoms from any stroke prior to the past year

Trial population

Patients with a diagnosis of CML or CLL scheduled to receive first dose of TKI therapy within 30 days or have received first dose of TKI within the previous 30 days, as well as cancer-free individuals.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 2 trial groups
Group A: Observational group I
Group B: Observational group II

Trial outcomes

Primary outcomes

1

Subjective cognitive performance

Will be assessed using the FACT-Cog. Will apply multilevel models to study data. Will include main effects of time, group, and the group X time interaction.

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester NCORP Research Base

Lead sponsor

National Cancer Institute (NCI)

Collaborator