Serial Testing To Assess Cognitive Function In Cancer

Cancer Clinical Trial

Official title:

Serial Testing To Assess Cognitive Function In Patients With Cancer Being Treated With Immunotherapy

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT06160700
• Other study ID #: CTO-IUSCCC-0770
• Status: Suspended
• Start date: April 20, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 188
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Immunotherapy Only Group:

1. Age = 18 years old

2. Ability to provide written informed consent and HIPAA authorization.

3. Patients with any type or stage of cancer eligible to begin treatment with immunotherapy alone. Note: Prior radiation therapy if not to the brain is acceptable.

Inclusion Criteria for Chemotherapy plus Immunotherapy Control Arm:

1. Age = 18 years old

2. Ability to provide written informed consent and HIPAA authorization.

3. Patients with any stage of cancer eligible to begin treatment with chemoimmunotherapy. Note: Prior radiation therapy if not to the brain is acceptable. Note: Patients receiving chemotherapy followed by immunotherapy between baseline and the 3 months MoCA will be eligible.

Inclusion Criteria for Patients not on Active Treatment Control Arm:

1. Age = 18 years old

2. Ability to provide written informed consent and HIPAA authorization.

3. Patients with a prior history of cancer treated with surgery alone at least 1 year out of treatment OR surgery and neo-adjuvant/adjuvant chemotherapy who are at least 2 years out from treatment. If patients underwent any other form of treatment for their current malignancy, they will be excluded. Note: Prior radiation therapy if not to the brain is acceptable.

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Montreal Cognitive Assessment (MoCA)
MoCA is a method for evaluating cognition. This assessment will be conducted at baseline, month 3, and month 6.

Locations

Country	Name	City	State
United States	Indiana University Melvin and Bren Simon Comprehensive Cancer Center	Indianapolis	Indiana
United States	Sidney and Lois Eskenazi Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Cognitive Function Change	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.	Baseline and 6 months
Secondary	Changes in MoCA scores	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.	3 and 6 months