Serial Testing To Assess Cognitive Function In Cancer

Terminated

• Conditions: Cancer
• Interventions: Behavioral: Montreal Cognitive Assessment (MoCA)

• Registration Number: NCT06160700
• Lead Sponsor: Indiana University

Brief Summary

The purpose of this study is to examine the effects of immunotherapy on cognitive function of cancer patients and follow them clinically over a period of six months with the Montreal cognitive assessment (MoCA) to assess changes in cognition.

Detailed Description

"Chemo brain" has been described as a side effect of conventional chemotherapy and radiotherapy in cancer patients. With the advent of immunotherapy and progress made in treatment of cancer, long term-survival has increased which raises the question of preserving cognitive function in these patients. However, to date, no large center studies have been done to assess the effects of immunotherapy on cognitive function in patients of all cancer types. Studies that have been done are on preclinical models and very small number of patients, which remained inconclusive.

The primary objective of this pilot clinical trial is to estimate the rate of cognitive function change using the MoCA scale over 6 months in each individual group of patients with cancer treated with immunotherapy alone, combined chemotherapy and immunotherapy, and in patients with cancer on no active treatment, respectively. The secondary objective is to estimate the changes of MoCA scores after 3 months and 6 months in patients receiving immunotherapy alone for the treatment of their cancer.

Study Timeline

• Study Start: 2022-04-20
• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-11-29
• Study First Posted: 2023-12-07
• Primary Completion: 2024-03-12
• Study Completion: 2024-03-12
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients who screen positive for depression by PHQ-2 test defined as a score more than 3 will complete the PHQ-9 questionnaire. If they screen positive for depression on the PHQ-9 questionnaire (score of 10 or more) or refuse to complete it, they will be excluded.
2. Patients with a history of prior malignancy (excluding skin squamous cell or basal cell cancers).
3. Patients with history of brain radiation and brain metastasis.
4. Patients with a known prior diagnosis of cognitive dysfunction such as dementia from either Alzheimer's, vascular dementia, Parkinson's, mental retardation, head injury etc. Or any uncontrolled etiologies that can affect cognitive function such as anxiety, depression, bipolar disorder, schizophrenia and hypo/hyperthyroidism will be excluded.

Note: patients with controlled anxiety/ depression who don't screen positive on the PHQ-2 scale are eligible.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Immunotherapy Only	Montreal Cognitive Assessment (MoCA)	Subjects who are currently receiving immunotherapy only.
No Active Therapy Control Arm	Montreal Cognitive Assessment (MoCA)	Subjects who are no currently receiving active therapy.
Chemo-Immunotherapy Control Arm	Montreal Cognitive Assessment (MoCA)	Subjects who are receiving chemo-immunotherapy.

Primary Outcome Measures

Name	Time	Method
Rate of Cognitive Function Change	Baseline and 6 months	The changes in MoCA scores over 6 months in patients from each group will be plotted and summarized with mean change, standard deviation of change, and standard errors of mean change. The standardized response mean (SRM), calculated as the mean change from baseline to 6 months, divided by the standard deviation of change, will be reported as the main effect size for evaluating the magnitude of change in cognitive function.

Secondary Outcome Measures

Name	Time	Method
Changes in MoCA scores	3 and 6 months	Changes of MoCA scores at 3 months and 6 months from the immunotherapy group will be fitted by the mixed-effects linear model including time effects, which will describe the relationship between the common effect of MoCA score changes, the random effect of time, and the random error representing subjects' observation time.

Trial Locations

Locations (2)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Sidney and Lois Eskenazi Hospital; 🇺🇸 Indianapolis, Indiana, United States