Effects of ChemotherapyCFCCNCT01569932
Cognitive Changes in Adult Cancer Survivors
An observational study of Effects of Chemotherapy and Cognitive Impairment, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study will document the cognitive (mental) and functional abilities of newly diagnosed cancer patients. The study will also examine the changes in cognitive and functional abilities during and after chemotherapy (your cancer treatment). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Effects of Chemotherapy, Cognitive Impairment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jan 2013
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The final study population will include sixteen adults over the age of 40 years with newly-diagnosed locally-advanced breast, head and neck, ovarian, primary peritoneal, bladder , and urethral cancer although up to 25 patients will be approached for enrollment to account for losses to attrition.
Who may be able to join
- Subjects must be 40 years of age or older
- Subjects must be able to read, write and speak English fluently
- Treatment with a chemotherapy regimen that contains 5-fluorouracil or a platinum-based drug.
- Breast cancer subjects must be newly diagnosed with invasive lobular or ductal cancer (stages II and III)
- Head and Neck cancer subjects must be newly diagnosed with locally-advanced squamous cell carcinoma of the head and neck in oropharyngeal, hypopharyngeal and laryngeal sites (stages III and IV)
- Ovarian, fallopian tube, or primary peritoneal cancer subjects must be newly diagnosed with epithelial ovarian cancer (stages II - IV), fallopian tube cancer with pelvic extension (stages II-IV), or primary peritoneal cancer (stages III-IV)
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- Bladder, renal pelvis, or ureteral cancer subjects must be newly-diagnosed with muscle-invasive cancer (stages II - IV).
- Urethral cancer subjects must be newly diagnosed with cancer invading the corpus spongiosum, prostate, or periurethral muscle (stages II-IV)
- Subjects must be anticipated to receive chemotherapy without the concomitant treatment use of hormonal therapy or immunomodulators.
Who cannot join
- Subjects with other prior cancer diagnoses who have evidence of active disease
- Subjects who have received chemotherapy or radiation treatment within the past year (for any disease state)
- Subjects with melanoma or other non-squamous cell carcinoma of the head and neck
- Subjects with nasopharyngeal, sinonasal or lateral skull base tumors. Unintentional cranial irradiation can occur with treatment to these sites and could therefore not be completely eliminated from being associated with any cognitive deficits observed.
- Subjects with implanted non-MRI compatible metal objects, electrodes, pacemakers, intracardiac lines, or medication pumps
- Subjects with weight over 350 pounds (weight limit on MRI machine)
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- Subjects with a history of claustrophobia
- Subjects with an inability to lie flat for 20 minutes (for fcMRI scan)
- Life expectancy of less than 6 months
- Any medical condition the Principal Investigator (PI) determines would not make the study safe or in the best interest of the potential subject to participate in.
- Subjects who receive hormonal therapy therapy or immunomodulators as part of their cancer therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Cognitive and Functional Changes With Chemotherapy in Adult Cancer
This study will document the cognitive (mental) and functional abilities of newly diagnosed cancer patients. The study will also examine the changes in cognitive and functional abilities during and after chemotherapy (your cancer treatment).
A comprehensive set of questionnaires and tasks, or assessments, have been put together in order for doctors and nurses to learn more about the day to day functioning of newly diagnosed adult cancer patients. The investigators would also like to follow up with the same adult patients, during and following completion of their cancer treatment, to learn about the kinds of treatments they received and how their cognitive status and level of participation in activities of daily living has changed. With follow-up assessments, doctors and nurses can learn more about the complications or health problems that adult patients may experience as a result of undergoing cancer therapy. This is a study involving two visits. The first visit occurs within two weeks before starting your cancer therapy, specifically chemotherapy. The second visit occurs within two weeks of completing your chemotherapy.
Read the detailed description
Chemotherapy is increasingly used in the management of various cancers. There are reports in the literature of chemotherapy-induced cognitive impairments ranging from deficits in memory and attention to slowed information-processing and deficiencies in executive function, including planning and problem-solving. These deficits have been shown to affect work-place productivity and social role-functioning which present significant public health risks in an era of increased chemotherapy usage. However, previous studies investigating cognitive deficits after chemotherapy have mainly used neurocognitive assessments, which are limited in their utility for clinical diagnosis due to their likelihood for practice effects and low sensitivity for detecting subtle cognitive changes that may be functionally relevant to the patient.
Resting-state functional connectivity magnetic resonance imaging (fcMRI) is a sensitive test that measures resting-state neural network connectivity, reflecting the integrity between functionally-related brain regions. fcMRI has been used to delineate cortical neural networks involved in a variety of cognitive domains, including memory, and attention. The investigators believe that fcMRI will be more sensitive than neurocognitive tests alone for investigating chemotherapy-induced cognitive changes. The goal of this novel study is to use fcMRI to investigate cognitive changes after chemotherapy in an attempt to understand the currently unknown neurobiological mechanisms associated with this phenomenon.
This prospective study will investigate the presence of cognitive deficits after chemotherapy in cancer patients by assessing changes in three fcMRI-defined neural networks involved in cognition. The three networks include (1) Dorsal Frontal Attention network (2) "Default" network and (3) Cognition "Core" control network. Sixteen cancer patients scheduled for chemotherapy will undergo fcMRI of the brain and neurocognitive testing within two weeks before and after chemotherapy. Comparisons between time-points will establish the effect of chemotherapy on cognition.
Results obtained from this study in cancer patients will provide insight into the mechanisms underlying the development of chemotherapy-induced cognitive deficits. Knowledge of the development of chemotherapy-induced cognitive deficits will enhance positive outcomes by allowing practitioners and patients to be better informed of the potential cognitive consequences to anticipate. With patients equipped with such information before starting cancer treatment, they will be better able to manage their affairs and daily activities in such a way that allows them to maintain productive living through their course of cancer and its treatment.
- Conditions
- Effects of Chemotherapy, Cognitive Impairment
- Keywords
- chemobrain, chemotherapy, cognitive impairments, fcMRI, neurocognitive Assessments
- Medical subject headings
- Cognitive Dysfunction, Chemotherapy-Related Cognitive Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy | Patients will be assessed both before and after they undergo treatment with chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fcMRI
Baseline and post-chemotherapy fcMRI maps will be compared for changes in degree of activation within the cognition-associated cortical networks. To compute statistical significance, correlation co-efficients from the fcMRI will be converted to a normal distribution using Fischer's r-to-z transformation.
Measured: before and after chemotherapy
Secondary outcomes (1)
Correlation of change in fcMRI with change in neurocognitive test scores.
To assess the correlation between changes in cognition defined through standard neurocognitive tests and fcMRI among adult cancer patients after chemotherapy.
Measured: Baseline and at the completion of chemotherapy. Baseline visit must be no more than 2 weeks prior to start of chemotherapy. 2nd visit must occur within 2 weeks of last dose of chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startFeb 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of ChemotherapyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay F. Piccirillo, MD, Washington University School of Medicine
- Investigators
- Jay F Piccirillo, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569932
- Sponsor's protocol ID
- 201105082
- Acronym
- CFCC
- Status last verified
- Feb 2013
- First submitted
- 7 Mar 2012
- Last updated
- 26 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Functional Changes With Chemotherapy in Adult Cancer
- ClinicalTrials.gov ID
- NCT01569932
- Acronym / sponsor ID
- CFCC / 201105082
- Conditions
- Effects of Chemotherapy, Cognitive Impairment
- Keywords
- chemobrain, chemotherapy, cognitive impairments, fcMRI, neurocognitive Assessments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 3 Apr 2012 (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.
This study will document the cognitive (mental) and functional abilities of newly diagnosed cancer patients. The study will also examine the changes in cognitive and functional abilities during and after chemotherapy (your cancer treatment).
A comprehensive set of questionnaires and tasks, or assessments, have been put together in order for doctors and nurses to learn more about the day to day functioning of newly diagnosed adult cancer patients. The investigators would also like to follow up with the same adult patients, during and following completion of their cancer treatment, to learn about the kinds of treatments they received and how their cognitive status and level of participation in activities of daily living has changed. With follow-up assessments, doctors and nurses can learn more about the complications or health problems that adult patients may experience as a result of undergoing cancer therapy. This is a study involving two visits. The first visit occurs within two weeks before starting your cancer therapy, specifically chemotherapy. The second visit occurs within two weeks of completing your chemotherapy.
Detailed description
Chemotherapy is increasingly used in the management of various cancers. There are reports in the literature of chemotherapy-induced cognitive impairments ranging from deficits in memory and attention to slowed information-processing and deficiencies in executive function, including planning and problem-solving. These deficits have been shown to affect work-place productivity and social role-functioning which present significant public health risks in an era of increased chemotherapy usage. However, previous studies investigating cognitive deficits after chemotherapy have mainly used neurocognitive assessments, which are limited in their utility for clinical diagnosis due to their likelihood for practice effects and low sensitivity for detecting subtle cognitive changes that may be functionally relevant to the patient.
Resting-state functional connectivity magnetic resonance imaging (fcMRI) is a sensitive test that measures resting-state neural network connectivity, reflecting the integrity between functionally-related brain regions. fcMRI has been used to delineate cortical neural networks involved in a variety of cognitive domains, including memory, and attention. The investigators believe that fcMRI will be more sensitive than neurocognitive tests alone for investigating chemotherapy-induced cognitive changes. The goal of this novel study is to use fcMRI to investigate cognitive changes after chemotherapy in an attempt to understand the currently unknown neurobiological mechanisms associated with this phenomenon.
This prospective study will investigate the presence of cognitive deficits after chemotherapy in cancer patients by assessing changes in three fcMRI-defined neural networks involved in cognition. The three networks include (1) Dorsal Frontal Attention network (2) "Default" network and (3) Cognition "Core" control network. Sixteen cancer patients scheduled for chemotherapy will undergo fcMRI of the brain and neurocognitive testing within two weeks before and after chemotherapy. Comparisons between time-points will establish the effect of chemotherapy on cognition.
Results obtained from this study in cancer patients will provide insight into the mechanisms underlying the development of chemotherapy-induced cognitive deficits. Knowledge of the development of chemotherapy-induced cognitive deficits will enhance positive outcomes by allowing practitioners and patients to be better informed of the potential cognitive consequences to anticipate. With patients equipped with such information before starting cancer treatment, they will be better able to manage their affairs and daily activities in such a way that allows them to maintain productive living through their course of cancer and its treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chemotherapy | – | –Patients will be assessed both before and after they undergo treatment with chemotherapy. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The final study population will include sixteen adults over the age of 40 years with newly-diagnosed locally-advanced breast, head and neck, ovarian, primary peritoneal, bladder , and urethral cancer although up to 25 patients will be approached for enrollment to account for losses to attrition.
Key inclusion criteria (9 listed)
- Subjects must be 40 years of age or older
- Subjects must be able to read, write and speak English fluently
- Treatment with a chemotherapy regimen that contains 5-fluorouracil or a platinum-based drug.
- Breast cancer subjects must be newly diagnosed with invasive lobular or ductal cancer (stages II and III)
- Head and Neck cancer subjects must be newly diagnosed with locally-advanced squamous cell carcinoma of the head and neck in oropharyngeal, hypopharyngeal and laryngeal sites (stages III and IV)
Key exclusion criteria (11 listed)
- Subjects with other prior cancer diagnoses who have evidence of active disease
- Subjects who have received chemotherapy or radiation treatment within the past year (for any disease state)
- Subjects with melanoma or other non-squamous cell carcinoma of the head and neck
- Subjects with nasopharyngeal, sinonasal or lateral skull base tumors. Unintentional cranial irradiation can occur with treatment to these sites and could therefore not be completely eliminated from being associated with any cognitive deficits observed.
- Subjects with implanted non-MRI compatible metal objects, electrodes, pacemakers, intracardiac lines, or medication pumps
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in fcMRI
Time frame: before and after chemotherapy
Baseline and post-chemotherapy fcMRI maps will be compared for changes in degree of activation within the cognition-associated cortical networks. To compute statistical significance, correlation co-efficients from the fcMRI will be converted to a normal distribution using Fischer's r-to-z transformation.
1 secondary outcome
Correlation of change in fcMRI with change in neurocognitive test scores.
Time frame: Baseline and at the completion of chemotherapy. Baseline visit must be no more than 2 weeks prior to start of chemotherapy. 2nd visit must occur within 2 weeks of last dose of 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 26 Feb 2013.
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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.
Jay F Piccirillo, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Effects of Chemotherapy and Cognitive Impairment, run by Washington University School of Medicine 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?
The sponsor lists 9 inclusion and 11 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: finished, as of the sponsor's last update on 26 Feb 2013. 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.
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?
Change in fcMRI (time frame: before and after chemotherapy). 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 26 Feb 2013.