Clinical trial NCT06160700: Serial Testing To Assess Cognitive Function In Cancer
Official title: Serial Testing To Assess Cognitive Function In Patients With Cancer Being Treated With Immunotherapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Keywords: Cancer
Immunotherapy
Cognitive Assessment
Montreal Cognitive Assessment
Chemo Brain
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This will be a prospective single site pilot study enrolling subjects with any stage of cancer who are receiving immunotherapy as part of their treatment. Subjects will be recruited from the clinics of the IUSCCC and Eskenazi Health. Subjects will be matched into three groups based on demographics including age, sex and self-reported educational level.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Cognitive Function Change
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Changes in MoCA scores
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Sidney and Lois Eskenazi Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Nasser Hanna, MD
role: PRINCIPAL_INVESTIGATOR
References: