Status:
TERMINATED
Serial Testing To Assess Cognitive Function In Cancer
Lead Sponsor:
Indiana University
Conditions:
Cancer
Eligibility:
All Genders
18+ years
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 assessm...
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Immunotherapy Only Group:
- Age ≥ 18 years old
- Ability to provide written informed consent and HIPAA authorization.
- 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:
- Age ≥ 18 years old
- Ability to provide written informed consent and HIPAA authorization.
- 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:
- Age ≥ 18 years old
- Ability to provide written informed consent and HIPAA authorization.
- 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:
- 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.
- Patients with a history of prior malignancy (excluding skin squamous cell or basal cell cancers).
- Patients with history of brain radiation and brain metastasis.
- 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.
Exclusion
Key Trial Info
Start Date :
April 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 12 2024
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06160700
Start Date
April 20 2022
End Date
March 12 2024
Last Update
June 10 2024
Active Locations (2)
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1
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
2
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States, 46202