"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.
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.