CancerNCT06160700
Serial Testing To Assess Cognitive Function In Cancer
An observational study of Cancer, run by Indiana University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Montreal Cognitive Assessment (MoCA)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Apr 2022to 12 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 15Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Serial Testing To Assess Cognitive Function In Patients With Cancer Being Treated With Immunotherapy
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.
Read the 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
- Cancer
- Being tested
- Montreal Cognitive Assessment (MoCA)
- Keywords
- Cancer, Immunotherapy, Cognitive Assessment, Montreal Cognitive Assessment, Chemo Brain
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montreal Cognitive Assessment (MoCA)Behavioural
MoCA is a method for evaluating cognition. This assessment will be conducted at baseline, month 3, and month 6.
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy Only | Subjects who are currently receiving immunotherapy only. Receives: Behavioral: Montreal Cognitive Assessment (MoCA) | |
| Chemo-Immunotherapy Control Arm | Subjects who are receiving chemo-immunotherapy. Receives: Behavioral: Montreal Cognitive Assessment (MoCA) | |
| No Active Therapy Control Arm | Subjects who are no currently receiving active therapy. Receives: Behavioral: Montreal Cognitive Assessment (MoCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months
Secondary outcomes (1)
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.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start20 Apr 2022
- Primary completion12 Mar 2024
- Study completion12 Mar 2024
Why it stopped: loss of research support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasser Hanna, Indiana University
- Investigators
- Nasser Hanna, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160700
- Sponsor's protocol ID
- CTO-IUSCCC-0770
- Status last verified
- Jun 2024
- First submitted
- 29 Nov 2023
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Testing To Assess Cognitive Function In Patients With Cancer Being Treated With Immunotherapy
- ClinicalTrials.gov ID
- NCT06160700
- Acronym / sponsor ID
- CTO-IUSCCC-0770
- Conditions
- Cancer
- Keywords
- Cancer, Immunotherapy, Cognitive Assessment, Montreal Cognitive Assessment, Chemo Brain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: loss of research support
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy Only | – | Behavioral: Montreal Cognitive Assessment (MoCA)Subjects who are currently receiving immunotherapy only. |
| Chemo-Immunotherapy Control Arm | – | Behavioral: Montreal Cognitive Assessment (MoCA)Subjects who are receiving chemo-immunotherapy. |
| No Active Therapy Control Arm | – | Behavioral: Montreal Cognitive Assessment (MoCA)Subjects who are no currently receiving active therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- 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.
- Age ≥ 18 years old
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montreal Cognitive Assessment (MoCA)MoCA is a method for evaluating cognition. This assessment will be conducted at baseline, month 3, and month 6. | Behavioural | Chemo-Immunotherapy Control Arm, Immunotherapy Only, No Active Therapy Control Arm |
Primary outcome
Rate of Cognitive Function Change
Time frame: Baseline and 6 months
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.
1 secondary outcome
Changes in MoCA scores
Time frame: 3 and 6 months
Results and safety
The study was stopped early (reason given: loss of research support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
Related trials for Cancer
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasser Hanna, MD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: loss of research support). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Cognitive Function Change (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.