CancerPhase 1ChemobrainNCT00708045
A Multi-modality Imaging Assessment of Chemobrain
A Phase 1 study testing [18F]fluoro-2-deoxy-D-glucose (FDG) in people with Cancer, run by University of Utah at 1 site in United States.
Trial summary
Patients must have had their breast cancer treated at the Huntsman Cancer Institute to be eligible for this trial. OBJECTIVES: To use quantitative FDG-positron emission tomography (PET), functional MRI (fMRI) and co-registered anatomic MRI imaging to better understand the cognitive disorder known as "chemobrain" which… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- [18F]fluoro-2-deoxy-D-glucose (FDG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2007to 5 Feb 2015
- Phase
- Phase 1
- 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 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Inclusion criteria: Pre-screening will be conducted to ensure that all subjects are in good neurologic health with no history of seizures or other neurological disorders, and that they have no ferromagnetic implants or clips in their body. Subjects will be right-handed exclusive-English speakers with normal hearing.
Exclusion criteria: If a subject is found to have profound or severe depression after the Neuropsychological and Cognitive Testing session they may be excluded from the imaging portion of the study. This is justified as the imaging session would not be valid as the biologic correlates of depression rather than chemobrain would be imaged. Subjects found to have profound or severe depression will be notified and appropriate referral made to get them the necessary medical care to treat their depression.
Three cohorts of 8 women each under the age of 65 will be recruited for this exploratory pilot study. The "affected patient cohort" will be woman with complaints of cognitive or memory dysfunction who have received adjuvant chemotherapy for the treatment of breast cancer. These patients will be those being treated at Huntsman Cancer Hospital and be the patients of Dr Saundra Buys or Dr John Ward. The second "patient control cohort" will be age-matched woman with breast cancer who have undergone similar adjuvant chemotherapy for the same amount of time who have no complaints of memory dysfunction. Again these are primarily patients of Drs. Buys or Ward. The non-patient cohort will be age-matched woman who have not undergone any type of chemotherapy. These individuals will be recruited from friends of female family members of the two breast cancer cohorts. All individuals will be assessed for dementia and cognitive impairment using the same battery of dementia and cognitive/neuropsychological testing. All subjects will be age-matched as close as possible to eliminate age related cognitive effects. Subjects will be right-handed exclusive-English speakers with normal hearing. Pre-screening will be conducted to ensure that all subjects are in good neurologic health with no history of seizures or other neurological disorders, and that they have no ferromagnetic implants or clips in their body.
Up to 40 subjects may be enrolled to ensure 24 evaluable subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Patients must have had their breast cancer treated at the Huntsman Cancer Institute to be eligible for this trial.
OBJECTIVES:
Read more
To use quantitative FDG-positron emission tomography (PET), functional MRI (fMRI) and co-registered anatomic MRI imaging to better understand the cognitive disorder known as "chemobrain" which effects up to 16 -50% of individuals receiving long-term adjuvant chemotherapy [Tannock 2004, Matsuda 2005]. The study is exploratory to obtain proof of feasibility pilot data to support an eventual submission to the NIH.
Neuropsychological Testing A battery of testing will be used to assess the subjective complaints of cognitive impairment in the symptomatic patient cohort. Similarly the same battery of tests will be used to assure that the non-symptomatic patient control group and the age-matched normal controls do not exhibit any cognitive impairment. The following set of clinical tests will be performed to assess the degree of cognitive impairment in all subjects.
Read the detailed description
In this study, 3 groups of 8 women each, between the ages of 18 and 65, will participate in this study. The "affected patient group" will be women with complaints of memory dysfunction who have received adjuvant chemotherapy (one or more anticancer drugs used in combination with surgery), for the treatment of breast cancer. These patients will be those that are being treated at Huntsman Cancer Institute/Hospital.
The second "patient control group" will be age-matched (same age) women with breast cancer who have undergone similar chemotherapy and have no complaints of memory problems.
The non-patient group will be age-matched (same age) women who have not undergone any type of chemotherapy. These individuals will be recruited from friends of female family members of the two breast cancer groups.
All individuals will be assessed for dementia (intellectual deterioration) and brain problems using the same kind of neuropsychological testing. All subjects will be age-matched as close as possible, to eliminate age related effects. Subjects will be right-handed, primarily-English speakers with normal hearing.
The purpose of this study is to use modern imaging techniques to better understand chemobrain. These imaging techniques include FDG-PET (FDG is the abbreviation for the radiopharmaceutical fluorodeoxyglucose and PET is Positron Emission Tomography) and functional MRI (fMRI)). They will be used to look at the metabolism (chemical activity) in specific areas of the brain and the entire brain overall. By using FDG-PET doctors will see how the brain activates. By using fMRI doctors will see how the brain works when you are challenged with certain mental tasks that make you concentrate and remember. FDG-PET and fMRI might provide important information on the brain that may be connected with chemotherapy.
This study will be an important first step to understand the problem of chemobrain. The imaging evaluations will make it possible to explore the changes in brain function that may be responsible for chemobrain and hopefully make it possible to predict which people may be affected by this problem.
Many people who undergo chemotherapy particularly adjuvant chemotherapy have complained about cognitive dysfunction for many years. This cognitive decline effects up to 16 -50% of individuals receiving long-term adjuvant chemotherapy [Tannock 2004, Matsuda 2005].Cancer survivors frequently refer to this cognitive dysfunction as "chemobrain" or "chemofog." The majority of individuals who are affected are woman who have undergone adjuvant chemotherapy for breast cancer. The table below is a summary of many of the studies that have been performed assessing cognition and chemobrain.
Women who experience chemobrain typically complain of inability to concentrate, memory dysfunction, word finding difficulties, difficulty with learning, slowed processing abilities, and often difficulty with writing and speaking. A particularly disturbing complaint for many individuals is the inability to multitask. Only recently, have researchers begun studying the impact of chemotherapy on cognitive functioning. This is a difficult area to study however. Part of the problem in assessing chemobrain using scientific principals is sorting out which problems are due to chemotherapy and which are due to having a serious illness like cancer that can result in physical debilitation, depression, sleep disruption, hormone shifts, and fatigue--all of which can affect cognitive functioning.
There are a number of theories at to why chemobrain may occur. One is that some types of chemotherapy can cross the blood/brain barrier and cause neurotoxicity. Another is that the cognitive problems are created by certain free radicals, the toxic elements that many types of chemotherapy produce [Joshi 2005]. Another theory is that some people have a genetic background that makes them more susceptible to the effects of chemotherapy. Most likely it is not just a single etiologic factor but a multifactorial process that combine to predispose certain individuals to develop chemobrain. Chemotherapy isn't the only cancer treatment that may cause cognitive disturbance and memory complaints. Other cancer treatments that have been implicated as causing complaints of cognitive dysfunction include hormone therapy, immunotherapy, and radiation therapy. Hormone therapy is common in woman being treated with conventional chemotherapy. It is not entirely clear if women undergoing hormone therapy which alters the amount of systemic estrogen experience memory problems. Some studies link memory to the amount of estrogen in the brain. Other studies haven't found this link.
- Conditions
- Cancer
- Being tested
- [18F]fluoro-2-deoxy-D-glucose (FDG)
- Keywords
- Breast Cancer
- Medical subject headings
- Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]fluoro-2-deoxy-D-glucose (FDG)Drug
Also called FDG-PET, [18F]FDG, FDG-PET/CT
Brain scan with imaging tracer to assess brain tumor metabolism
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | All participants enrolled. Receives: Drug: [18F]fluoro-2-deoxy-D-glucose (FDG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To use quantitative FDG-PET, functional MRI (fMRI) and co-registered anatomic MRI imaging to better understand the cognitive disorder known as "chemobrain" which effects up to 16 -50% of individuals receiving long-term adjuvant chemotherapy
To use quantitative FDG-PET, functional MRI (fMRI) and co-registered anatomic MRI imaging to better understand the cognitive disorder known as "chemobrain" which effects up to 16 -50% of individuals receiving long-term adjuvant chemotherapy
Measured: December 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study start9 May 2007
- Primary completion5 Feb 2015
- Study completion5 Feb 2015
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 University of UtahThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Yapp, PhD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708045
- Sponsor's protocol ID
- HCI21946
- Acronym
- Chemobrain
- Status last verified
- Mar 2024
- First submitted
- 27 Jun 2008
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-modality Imaging Assessment of Chemobrain
- ClinicalTrials.gov ID
- NCT00708045
- Acronym / sponsor ID
- Chemobrain / HCI21946
- Conditions
- Cancer
- Keywords
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 9 May 2007 (actual)
- Primary completion
- 5 Feb 2015 (actual)
- Study completion
- 5 Feb 2015 (actual)
- First posted
- 2 Jul 2008 (estimated)
- 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.
Patients must have had their breast cancer treated at the Huntsman Cancer Institute to be eligible for this trial.
OBJECTIVES:
To use quantitative FDG-positron emission tomography (PET), functional MRI (fMRI) and co-registered anatomic MRI imaging to better understand the cognitive disorder known as "chemobrain" which effects up to 16 -50% of individuals receiving long-term adjuvant chemotherapy [Tannock 2004, Matsuda 2005]. The study is exploratory to obtain proof of feasibility pilot data to support an eventual submission to the NIH.
Neuropsychological Testing A battery of testing will be used to assess the subjective complaints of cognitive impairment in the symptomatic patient cohort. Similarly the same battery of tests will be used to assure that the non-symptomatic patient control group and the age-matched normal controls do not exhibit any cognitive impairment. The following set of clinical tests will be performed to assess the degree of cognitive impairment in all subjects.
Detailed description
In this study, 3 groups of 8 women each, between the ages of 18 and 65, will participate in this study. The "affected patient group" will be women with complaints of memory dysfunction who have received adjuvant chemotherapy (one or more anticancer drugs used in combination with surgery), for the treatment of breast cancer. These patients will be those that are being treated at Huntsman Cancer Institute/Hospital.
The second "patient control group" will be age-matched (same age) women with breast cancer who have undergone similar chemotherapy and have no complaints of memory problems.
The non-patient group will be age-matched (same age) women who have not undergone any type of chemotherapy. These individuals will be recruited from friends of female family members of the two breast cancer groups.
All individuals will be assessed for dementia (intellectual deterioration) and brain problems using the same kind of neuropsychological testing. All subjects will be age-matched as close as possible, to eliminate age related effects. Subjects will be right-handed, primarily-English speakers with normal hearing.
The purpose of this study is to use modern imaging techniques to better understand chemobrain. These imaging techniques include FDG-PET (FDG is the abbreviation for the radiopharmaceutical fluorodeoxyglucose and PET is Positron Emission Tomography) and functional MRI (fMRI)). They will be used to look at the metabolism (chemical activity) in specific areas of the brain and the entire brain overall. By using FDG-PET doctors will see how the brain activates. By using fMRI doctors will see how the brain works when you are challenged with certain mental tasks that make you concentrate and remember. FDG-PET and fMRI might provide important information on the brain that may be connected with chemotherapy.
This study will be an important first step to understand the problem of chemobrain. The imaging evaluations will make it possible to explore the changes in brain function that may be responsible for chemobrain and hopefully make it possible to predict which people may be affected by this problem.
Many people who undergo chemotherapy particularly adjuvant chemotherapy have complained about cognitive dysfunction for many years. This cognitive decline effects up to 16 -50% of individuals receiving long-term adjuvant chemotherapy [Tannock 2004, Matsuda 2005].Cancer survivors frequently refer to this cognitive dysfunction as "chemobrain" or "chemofog." The majority of individuals who are affected are woman who have undergone adjuvant chemotherapy for breast cancer. The table below is a summary of many of the studies that have been performed assessing cognition and chemobrain.
Women who experience chemobrain typically complain of inability to concentrate, memory dysfunction, word finding difficulties, difficulty with learning, slowed processing abilities, and often difficulty with writing and speaking. A particularly disturbing complaint for many individuals is the inability to multitask. Only recently, have researchers begun studying the impact of chemotherapy on cognitive functioning. This is a difficult area to study however. Part of the problem in assessing chemobrain using scientific principals is sorting out which problems are due to chemotherapy and which are due to having a serious illness like cancer that can result in physical debilitation, depression, sleep disruption, hormone shifts, and fatigue--all of which can affect cognitive functioning.
There are a number of theories at to why chemobrain may occur. One is that some types of chemotherapy can cross the blood/brain barrier and cause neurotoxicity. Another is that the cognitive problems are created by certain free radicals, the toxic elements that many types of chemotherapy produce [Joshi 2005]. Another theory is that some people have a genetic background that makes them more susceptible to the effects of chemotherapy. Most likely it is not just a single etiologic factor but a multifactorial process that combine to predispose certain individuals to develop chemobrain. Chemotherapy isn't the only cancer treatment that may cause cognitive disturbance and memory complaints. Other cancer treatments that have been implicated as causing complaints of cognitive dysfunction include hormone therapy, immunotherapy, and radiation therapy. Hormone therapy is common in woman being treated with conventional chemotherapy. It is not entirely clear if women undergoing hormone therapy which alters the amount of systemic estrogen experience memory problems. Some studies link memory to the amount of estrogen in the brain. Other studies haven't found this link.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Drug: [18F]fluoro-2-deoxy-D-glucose (FDG)All participants enrolled. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| [18F]fluoro-2-deoxy-D-glucose (FDG)Also: FDG-PET, [18F]FDG, FDG-PET/CTBrain scan with imaging tracer to assess brain tumor metabolism | Drug | All patients |
Primary outcome
To use quantitative FDG-PET, functional MRI (fMRI) and co-registered anatomic MRI imaging to better understand the cognitive disorder known as "chemobrain" which effects up to 16 -50% of individuals receiving long-term adjuvant chemotherapy
Time frame: December 2011
To use quantitative FDG-PET, functional MRI (fMRI) and co-registered anatomic MRI imaging to better understand the cognitive disorder known as "chemobrain" which effects up to 16 -50% of individuals receiving long-term adjuvant chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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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.
Jeffrey Yapp, PhD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F]fluoro-2-deoxy-D-glucose (FDG) in people with Cancer, run by University of Utah at 1 site 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?
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: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To use quantitative FDG-PET, functional MRI (fMRI) and co-registered anatomic MRI imaging to better understand the cognitive disorder known as "chemobrain" which effects up to 16 -50% of individuals receiving long-term adjuvant chemotherapy (time frame: December 2011). 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 15 Mar 2024.