Chemotherapy-induced Cognitive ImpairmentNCT03324945
Chemotherapy-Induced Cognitive Impairment in Ovarian Cancer Patients
A study testing Neurocognitive assessments in people with Chemotherapy-induced Cognitive Impairment, run by Rachel Miller at 1 site in United States.
Trial summary
Chemotherapy-induced cognitive impairment (CICI), also known as "chemobrain," is a spectrum of neurocognitive deficits experienced during and after the administration of chemotherapy for cancer. The incidence of CICI is significant, affecting anywhere from 25 to 75% of survivors, and the biologic basis is unknown. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chemotherapy-induced Cognitive Impairment
- What is being tested?
- Neurocognitive assessments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 1 Apr 2019
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with any stage epithelial ovarian cancer, including cancers arising from the fallopian tube and primary peritoneal cancer, or patients with other gynecologic malignancy (any stage), who are chemotherapy-naïve, and scheduled to undergo at least 6 cycles of intravenous platinum/taxane-based chemotherapy.
- Patients must have adequate bone marrow, renal, hepatic, and sensory neurologic function to be eligible to receive platinum/taxane-based chemotherapy.
- Patients must have a World Health Organization Performance Status of ≤ 2.
- Age ≥18 years.
- Ability to understand and the willingness to sign an approved written informed consent document.
Who cannot join
- Patients who have received prior cytotoxic chemotherapy are ineligible. Patients may have received prior adjuvant hormonal therapy for localized breast cancer, provided that it was completed prior to registration, and that the patient remains free of recurrent or metastatic disease.
- Patients undergoing neoadjuvant chemotherapy with planned interval cytoreductive surgery and adjuvant therapy are not included in this group.
- Patients who are receiving any other investigational agents are excluded.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic outcomes and other adverse events.
- With the exception of non-melanoma skin cancer and other specific malignancies noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this therapy are excluded.
- Patients with underlying dementia (or on medications to treat Alzheimer's disease such as donepezil, rivastigmine, galantamine, tacrine, or memantine), encephalopathy, or other neurological disorder known to adversely affect cognition (such as epilepsy or prior stroke) are excluded. (Patients with depression or anxiety are not excluded).
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- Patients will be excluded from fMRI testing if they are left-handed, claustrophobic, have a pacemaker, or have metal implants. Patients not undergoing fMRI testing may still enroll in clinical trial, including the ERP testing, if all other eligibility criteria are met.
- Patients who are pregnant or nursing are excluded. Pregnant women are excluded from this study because cytotoxic chemotherapy has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cytotoxic chemotherapy, breastfeeding should be discontinued if the mother is treated with cytotoxic chemotherapy.
- Patients who are non-English speaking are excluded because of the inability to adequately administer neurocognitive testing in non-English languages.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536
About this study
Official title: Chemotherapy-Induced Cognitive Impairment in Patients With Ovarian Cancer: A Phase II Study of the Cognitive Effects of Platinum/Taxane-based Chemotherapy in Patients With Ovarian Cancer
Chemotherapy-induced cognitive impairment (CICI), also known as "chemobrain," is a spectrum of neurocognitive deficits experienced during and after the administration of chemotherapy for cancer. The incidence of CICI is significant, affecting anywhere from 25 to 75% of survivors, and the biologic basis is unknown. This novel study is designed to address the questions of incidence and biological cause for CICI, while gaining a better understanding of the structural and functional effects of chemotherapy on the brain.
Read the detailed description
Chemotherapy-induced cognitive impairment (CICI), also known as "chemobrain," is a spectrum of neurocognitive deficits experienced during and after the administration of chemotherapy for cancer. The incidence of CICI is significant, affecting anywhere from 25 to 75% of survivors, and the biologic basis is unknown. This novel study is designed to address the questions of incidence and biological cause for CICI, while gaining a better understanding of the structural and functional effects of chemotherapy on the brain. In order to address these important objectives, a diverse team of experienced investigators has been assembled to design and implement the proposed protocol. The research team for this project seeks to accomplish the proposed objectives through following mechanisms: 1) assessment of the neurocognitive domains affected in CICI using a tailored battery of cognitive tests to define CICI; 2) measurement of serum markers of oxidative stress and correlation of these markers with neurocognitive test results; and 3) exploration of structural and functional changes in the brain during cognitive tasks and correlation of results with markers of oxidative stress and neurocognitive test results.
- Being tested
- Neurocognitive assessments
- Medical subject headings
- Chemotherapy-Related Cognitive Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive assessmentsBehavioural
Baseline and post-chemotherapy neurocognitive testing. A sequentially-assigned subset of participants also receive baseline and post-chemotherapy neuroimaging (FMRI)
| Study group | Role | What they receive |
|---|---|---|
| Neurocognitive Assessment +/- FMRI | Experimental | All participants receive pre- and post-chemotherapy neurocognitive assessments. A sequentially-assigned subset also receive pre- and post-chemotherapy Functional Magnetic Resonance Imaging (FMRI) procedures. Receives: Behavioral: Neurocognitive assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliable Change Index (RCI)
To address the primary aim, RCI (which is essentially a z-score) for each patient will be calculated from the pre-, post-chemotherapy Montreal Cognitive Assessment (MoCA) test results. Then a Wilcoxon signed rank test will be applied to the RCI values with corresponding 95% confidence intervals.
Measured: 4 weeks after completing cycle #6 chemotherapy (each cycle is 21 days)
Secondary outcomes (2)
Assess the correlation between biologic markers of oxidative stress and neurocognitive test results.
Analysis of covariance (ANCOVA), adjusting for baseline log serum levels, will be utilized to assess for differences in log levels over timepoints including the 4 and 6 hour samples. Spearman correlations will be utilized to describe associations with cognitive tests scores and biochemical measured in addition to Spearman Correlation coefficients between baseline biochemical measures.
Measured: 4 weeks after completing cycle #6 chemotherapy (each cycle is 21 days)
Assess the correlation between brain imaging and neurocognitive test results
For neurological outcomes, a longitudinal comparison before and after Chemotherapy in fMRI (percent signal change and extend of activation voxels), DTI (FA % change), and ERP (uV) will be performed. There will be changes in patterns of fMRI responses, FA, and ERP signals from baseline to after treatment. We expect that fMRI activation will be change in prefrontal regions change of effort needed to do the memory task. Changes in white matter FA in after the treatment may be observable in the white matter regions such as the frontal and temporal cortices as well as in gray matter regions suspected to be affected by the Chemo. Cognitive ERP patterns will be changed in the same individuals. fMRI and ERP analysis can be analyzed and compared at individual level.
To explore correlations between fMRI outcomes and cognitive measures, ANCOVA is an appropriate choice since we want to study measures after treatment, relative to initial values.
Measured: 4 weeks after completing cycle #6 chemotherapy (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start1 Aug 2016
- Primary completion12 Oct 2018
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Cognitive ImpairmentStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rachel Miller
- Sponsor type
- University, hospital or other
- Collaborators
- Office of US Army Medical Research and Material Command
- Responsible party
- Sponsor-investigator, Rachel Miller, University of Kentucky
- Investigators
- Rachel W Miller, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324945
- Sponsor's protocol ID
- MCC-15-GYN-333
- Status last verified
- Nov 2020
- First submitted
- 15 Sep 2017
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy-Induced Cognitive Impairment in Patients With Ovarian Cancer: A Phase II Study of the Cognitive Effects of Platinum/Taxane-based Chemotherapy in Patients With Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03324945
- Acronym / sponsor ID
- MCC-15-GYN-333
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Rachel MillerUniversity, hospital or other
- Collaborators
- Office of US Army Medical Research and Material Command
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 12 Oct 2018 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 30 Oct 2017 (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.
Chemotherapy-induced cognitive impairment (CICI), also known as "chemobrain," is a spectrum of neurocognitive deficits experienced during and after the administration of chemotherapy for cancer. The incidence of CICI is significant, affecting anywhere from 25 to 75% of survivors, and the biologic basis is unknown. This novel study is designed to address the questions of incidence and biological cause for CICI, while gaining a better understanding of the structural and functional effects of chemotherapy on the brain.
Detailed description
Chemotherapy-induced cognitive impairment (CICI), also known as "chemobrain," is a spectrum of neurocognitive deficits experienced during and after the administration of chemotherapy for cancer. The incidence of CICI is significant, affecting anywhere from 25 to 75% of survivors, and the biologic basis is unknown. This novel study is designed to address the questions of incidence and biological cause for CICI, while gaining a better understanding of the structural and functional effects of chemotherapy on the brain. In order to address these important objectives, a diverse team of experienced investigators has been assembled to design and implement the proposed protocol. The research team for this project seeks to accomplish the proposed objectives through following mechanisms: 1) assessment of the neurocognitive domains affected in CICI using a tailored battery of cognitive tests to define CICI; 2) measurement of serum markers of oxidative stress and correlation of these markers with neurocognitive test results; and 3) exploration of structural and functional changes in the brain during cognitive tasks and correlation of results with markers of oxidative stress and neurocognitive test results.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurocognitive Assessment +/- FMRI | Experimental | Behavioral: Neurocognitive assessmentsAll participants receive pre- and post-chemotherapy neurocognitive assessments. A sequentially-assigned subset also receive pre- and post-chemotherapy Functional Magnetic Resonance Imaging (FMRI) procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with any stage epithelial ovarian cancer, including cancers arising from the fallopian tube and primary peritoneal cancer, or patients with other gynecologic malignancy (any stage), who are chemotherapy-naïve, and scheduled to undergo at least 6 cycles of intravenous platinum/taxane-based chemotherapy.
- Patients must have adequate bone marrow, renal, hepatic, and sensory neurologic function to be eligible to receive platinum/taxane-based chemotherapy.
- Patients must have a World Health Organization Performance Status of ≤ 2.
- Age ≥18 years.
- Ability to understand and the willingness to sign an approved written informed consent document.
Key exclusion criteria (9 listed)
- Patients who have received prior cytotoxic chemotherapy are ineligible. Patients may have received prior adjuvant hormonal therapy for localized breast cancer, provided that it was completed prior to registration, and that the patient remains free of recurrent or metastatic disease.
- Patients undergoing neoadjuvant chemotherapy with planned interval cytoreductive surgery and adjuvant therapy are not included in this group.
- Patients who are receiving any other investigational agents are excluded.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic outcomes and other adverse events.
- With the exception of non-melanoma skin cancer and other specific malignancies noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this therapy are excluded.
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 |
|---|---|---|
| Neurocognitive assessmentsBaseline and post-chemotherapy neurocognitive testing. A sequentially-assigned subset of participants also receive baseline and post-chemotherapy neuroimaging (FMRI) | Behavioural | Neurocognitive Assessment +/- FMRI |
Primary outcome
Reliable Change Index (RCI)
Time frame: 4 weeks after completing cycle #6 chemotherapy (each cycle is 21 days)
To address the primary aim, RCI (which is essentially a z-score) for each patient will be calculated from the pre-, post-chemotherapy Montreal Cognitive Assessment (MoCA) test results. Then a Wilcoxon signed rank test will be applied to the RCI values with corresponding 95% confidence intervals.
2 secondary outcomes
Assess the correlation between biologic markers of oxidative stress and neurocognitive test results.
Time frame: 4 weeks after completing cycle #6 chemotherapy (each cycle is 21 days)
Assess the correlation between brain imaging and neurocognitive test results
Time frame: 4 weeks after completing cycle #6 chemotherapy (each cycle is 21 days)
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 12 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Rachel W Miller, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurocognitive assessments in people with Chemotherapy-induced Cognitive Impairment, run by Rachel Miller 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 5 inclusion and 9 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 12 Nov 2020. 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?
Reliable Change Index (RCI) (time frame: 4 weeks after completing cycle #6 chemotherapy (each cycle is 21 days)). 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 12 Nov 2020.