Pilot Study of Care at Home for Monitoring Brain Tumor Patients

Overview

About this study

The purpose of this study is to determine the feasibility of completing serial remote cognitive, activity/sleep, and selfreport assessments in clinical trial participants who have previously received cranial radiation.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of brain tumor requiring cranial radiation treatment NOTE: Patient may be enrolled during or up to 3 years after completion of cranial radiation administered for treatment of primary or metastatic intracranial tumor
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, AND Karnofsky performance status (KPS) of ≥ 70
* Expected survival ≥ 6 months in the opinion of treatment team
* Willing and able to adhere with the protocol for the duration of the study including undergoing treatment, and attending scheduled visits, and examinations
* The following laboratory values obtained ≤ 30 days prior to registration:

* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN \[≤ 5 x upper limit normal (ULN) for patients with baseline liver disease\]
* Negative pregnancy test ≤ 8 days prior to registration for persons of childbearing potential only
* Ability to complete cognitive assessments and questionnaires by themselves or with assistance

Exclusion Criteria:

* Uncontrolled and/or intercurrent illness or other condition which limits safety of or compliance with study proceedings
* Pregnant or nursing, imprisoned, or lacking capacity for understanding
* Unable to swallow tablets or at risk for impaired absorption of oral medication
* Currently taking the study agent (i.e., metformin), and cannot safely discontinue if randomized to the control group (Group B)
* Known hypersensitivity or allergy to metformin
* Current use of resveratrol, CoQ10 (coenzyme Q10), coconut oil/other medium chain triglyceride-containing (e.g., Axona) supplements, or curcumin and unwilling to discontinue prior to registration and remain off these agents for study duration
* Unable to read and speak English. Note: English doses not to need to be primary language

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/5/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ugur Sener, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available