Trials / Terminated
TerminatedNCT06160700
Serial Testing To Assess Cognitive Function In Cancer
Serial Testing To Assess Cognitive Function In Patients With Cancer Being Treated With Immunotherapy
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 54 (actual)
- Sponsor
- Indiana University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Montreal Cognitive Assessment (MoCA) | MoCA is a method for evaluating cognition. This assessment will be conducted at baseline, month 3, and month 6. |
Timeline
- Start date
- 2022-04-20
- Primary completion
- 2024-03-12
- Completion
- 2024-03-12
- First posted
- 2023-12-07
- Last updated
- 2024-06-10
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06160700. Inclusion in this directory is not an endorsement.