Malignant Female Reproductive System NeoplasmNCT04593550
Electroencephalographic Changes Under General Anesthesia in Patients With Gynecologic Cancers With and Without History of Chemotherapy
An observational study of Malignant Female Reproductive System Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study compares changes in brain waves in women with gynecologic cancers who have or have not received chemotherapy and who are scheduled to receive surgery as part of their standard care. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Malignant Female Reproductive System Neoplasm
- What is being tested?
- Biospecimen Collection, BrainCheck Cognitive Assessment and Cognitive Assessment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2020to 17 Nov 2023
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with gynecologic cancers with or without history of preoperative chemotherapy
Who may be able to join
- Written informed consent;
- Women between 40-60 years of age; with or without history of systemic chemotherapy;
- American Society of Anesthesiologists physical status (ASA) 1-3;
- Scheduled surgery: open gynecologic surgery;
- Able to complete all study questionnaires.
Who cannot join
- Emergency surgery
- ASA ≥ 4
- Patients with extra-abdominal metastatic disease
- Patients unable to complete preoperative and postoperative cognitive tests
- Non-English-speaking patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Identify Electroencephalographic Changes Under General Anesthesia in Patients With and Without History of Chemotherapy
This study compares changes in brain waves in women with gynecologic cancers who have or have not received chemotherapy and who are scheduled to receive surgery as part of their standard care. Electroencephalography is a test that measures brain waves and may help learn if sensitivity to anesthesia is higher in women who have received chemotherapy than women who have not. This study may help researchers learn if receiving chemotherapy before surgery can affect the way the brain responds to anesthesia during and after surgery.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess electroencephalography (EEG) changes of women with and without history of chemotherapy exposure undergoing volatile general anesthesia.
SECONDARY OBJECTIVE:
- To evaluate if chemotherapy-induced cognitive impairment is associated with an increased sensitivity to general anesthetic agents captured by the patient state index (PSI) and observable in changes in alpha (8-12 H) activity in the frontal regions of the EEG) and other study features such as EEG power, burst suppression analysis, burst suppression ratio, and coherence analysis.
EXPLORATORY OBJECTIVES:
- To assess the relationship between preoperative cognitive function and electroencephalographic changes under general anesthesia.
II. To assess the relationship between EEG signatures under general anesthesia and postoperative cognitive function.
III. To collect blood specimens for extracting information on serum lipids and cytokines at two different times, before anesthetic induction, and 30 to 60 minutes upon arrival to the postoperative anesthesia care unit.
OUTLINE:
Patients undergo cognitive function assessment BrainCheck over 10 minutes before surgery, day 1 after surgery, and day 2 after surgery (if patients are still admitted to the hospital) and 3D-confusion assessment over 10 minutes twice daily (BID) on day 1 after surgery and day 2 after surgery (if patients are still admitted to the hospital). Patients also undergo EEG during surgery and collection of blood samples 30-60 minutes after surgery.
- Being tested
- Biospecimen Collection, BrainCheck Cognitive Assessment, Cognitive Assessment, Electroencephalography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood samples
BrainCheck Cognitive AssessmentBehavioural
Also called BrainCheck
Undergo cognitive function assessment BrainCheck
Cognitive AssessmentProcedure or surgery
Undergo 3D-Confusion assessment
ElectroencephalographyProcedure or surgery
Also called EEG, electroencephalogram
Undergo EEG
| Study group | Role | What they receive |
|---|---|---|
| Observational (BrainCheck, 3D-CAM, EEG) | Patients undergo cognitive function assessment BrainCheck over 10 minutes before surgery, day 1 after surgery, and day 2 after surgery (if patients are still admitted to the hospital) and 3D-confusion assessment over 10 minutes BID on day 1 after surgery and day 2 after surgery (if patients are still admitted to the hospital). Patients also undergo EEG during surgery and collection of blood samples 30-60 minutes after surgery. Receives: Procedure: Biospecimen Collection; Behavioral: BrainCheck Cognitive Assessment; Procedure: Cognitive Assessment; Procedure: Electroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the amplitude of alpha oscillations 15 minutes after incision
Data will be analyzed using descriptive statistics and visualizations of the data to establish patterns of symmetry, skewness, and outliers. Will explore differences in the analysis of the alpha oscillations
Measured: 15 minutes after incision
Secondary outcomes (5)
Patient State Index (PSI)
For each participant, the PSI will be recorded from the SedLine monitor. Data will be analyzed using descriptive statistics and visualizations of the data to establish patterns of symmetry, skewness, and outliers. PSI will be analyzed between both groups of patients using an independent samples t-test or Wilcoxon's ranksum test, if more appropriate. Chi-square or Fisher's exact tests will be used if study outcomes are categorical. Finally, will also use both Pearson and Spearman's correlation to assess the association between study features such as PSI and cognitive function.
Measured: Up to 2 days post surgery
Electroencephalography (EEG) power
For each participant, will calculate the slow (0.1-1 Hz), delta (1-4 Hz), theta (4-8 Hz), alpha (8-12 Hz), beta (12-25 Hz), gamma (25-40Hz), and total power (0.1-40Hz). Data will be analyzed using descriptive statistics and visualizations of the data to establish patterns of symmetry, skewness, and outliers. Will explore EEG power between both groups of patients using an independent samples t-test or Wilcoxon's ranksum test, if more appropriate. Chi-square or Fisher's exact tests will be used if study outcomes are categorical. Finally, will also use both Pearson and Spearman's correlation to assess the association between study features such as EEG power and cognitive function.
Measured: During surgery
Burst suppression analysis
When delivered in a sufficiently high dose, intravenous and volatile anesthetics induce burst suppression. This will be obtained from visual inspection of EEG spectrograms. For each participant, burst suppression will be considered significant if three or more events are observed within 2 min period of stable anesthesia. Data will be analyzed using descriptive statistics and visualizations of the data to establish patterns of symmetry, skewness, and outliers. Will explore burst suppression between both groups of patients using an independent samples t-test or Wilcoxon's ranksum test, if more appropriate. Chi-square or Fisher's exact tests will be used if study outcomes are categorical.
Measured: During surgery
Burst suppression ratio
Burst suppression ratio is defined as a time domain measure used to track quantitatively the level of burst suppression. It ranges from 0 to 1 and is one of the parameters used to determine depth-of- anesthesia. Data will be analyzed using descriptive statistics and visualizations of the data to establish patterns of symmetry, skewness, and outliers. Will explore burst suppression ratio between both groups of patients using an independent samples t-test or Wilcoxon's ranksum test, if more appropriate. Chi-square or Fisher's exact tests will be used if study outcomes are categorical. Finally, will also use both Pearson and Spearman's correlation to assess the association between study features such as burst suppression ratio for each band and cognitive function.
Measured: During surgery
Coherence analysis
Will be calculated as a measure of synchrony between two signals at the same frequency as previously described by Purdon et al. Data will be analyzed using descriptive statistics and visualizations of the data to establish patterns of symmetry, skewness, and outliers. Will explore coherence between both groups of patients using an independent samples t-test or Wilcoxon's ranksum test, if more appropriate. Chi-square or Fisher's exact tests will be used if study outcomes are categorical.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start31 Jul 2020
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Female Reproductive System NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan P Cata, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593550
- Sponsor's protocol ID
- 2019-1120
- Other IDs
- NCI-2020-06076, 2019-1120
- Status last verified
- Nov 2023
- First submitted
- 29 Sep 2020
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Identify Electroencephalographic Changes Under General Anesthesia in Patients With and Without History of Chemotherapy
- ClinicalTrials.gov ID
- NCT04593550
- Acronym / sponsor ID
- 2019-1120
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 20 Oct 2020 (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.
This study compares changes in brain waves in women with gynecologic cancers who have or have not received chemotherapy and who are scheduled to receive surgery as part of their standard care. Electroencephalography is a test that measures brain waves and may help learn if sensitivity to anesthesia is higher in women who have received chemotherapy than women who have not. This study may help researchers learn if receiving chemotherapy before surgery can affect the way the brain responds to anesthesia during and after surgery.
Detailed description
PRIMARY OBJECTIVE:
- To assess electroencephalography (EEG) changes of women with and without history of chemotherapy exposure undergoing volatile general anesthesia.
SECONDARY OBJECTIVE:
- To evaluate if chemotherapy-induced cognitive impairment is associated with an increased sensitivity to general anesthetic agents captured by the patient state index (PSI) and observable in changes in alpha (8-12 H) activity in the frontal regions of the EEG) and other study features such as EEG power, burst suppression analysis, burst suppression ratio, and coherence analysis.
EXPLORATORY OBJECTIVES:
- To assess the relationship between preoperative cognitive function and electroencephalographic changes under general anesthesia.
II. To assess the relationship between EEG signatures under general anesthesia and postoperative cognitive function.
III. To collect blood specimens for extracting information on serum lipids and cytokines at two different times, before anesthetic induction, and 30 to 60 minutes upon arrival to the postoperative anesthesia care unit.
OUTLINE:
Patients undergo cognitive function assessment BrainCheck over 10 minutes before surgery, day 1 after surgery, and day 2 after surgery (if patients are still admitted to the hospital) and 3D-confusion assessment over 10 minutes twice daily (BID) on day 1 after surgery and day 2 after surgery (if patients are still admitted to the hospital). Patients also undergo EEG during surgery and collection of blood samples 30-60 minutes after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (BrainCheck, 3D-CAM, EEG) | – | Procedure: Biospecimen Collection, Behavioral: BrainCheck Cognitive Assessment, Procedure: Cognitive Assessment, Procedure: ElectroencephalographyPatients undergo cognitive function assessment BrainCheck over 10 minutes before surgery, day 1 after surgery, and day 2 after surgery (if patients are still admitted to the hospital) and 3D-confusion assessment over 10 minutes BID on day 1 after surgery and day 2 after surgery (if patients are still admitted to the hospital). Patients also undergo EEG during surgery and collection of blood samples 30-60 minutes after surgery. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with gynecologic cancers with or without history of preoperative chemotherapy
Key inclusion criteria (5 listed)
- Written informed consent;
- Women between 40-60 years of age; with or without history of systemic chemotherapy;
- American Society of Anesthesiologists physical status (ASA) 1-3;
- Scheduled surgery: open gynecologic surgery;
- Able to complete all study questionnaires.
Key exclusion criteria (5 listed)
- Emergency surgery
- ASA ≥ 4
- Patients with extra-abdominal metastatic disease
- Patients unable to complete preoperative and postoperative cognitive tests
- Non-English-speaking patients
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 |
|---|---|---|
| Biospecimen CollectionUndergo collection of blood samples | Procedure or surgery | Observational (BrainCheck, 3D-CAM, EEG) |
| BrainCheck Cognitive AssessmentAlso: BrainCheckUndergo cognitive function assessment BrainCheck | Behavioural | Observational (BrainCheck, 3D-CAM, EEG) |
| Cognitive AssessmentUndergo 3D-Confusion assessment | Procedure or surgery | Observational (BrainCheck, 3D-CAM, EEG) |
| ElectroencephalographyAlso: EEG, electroencephalogramUndergo EEG | Procedure or surgery | Observational (BrainCheck, 3D-CAM, EEG) |
Primary outcome
Difference in the amplitude of alpha oscillations 15 minutes after incision
Time frame: 15 minutes after incision
Data will be analyzed using descriptive statistics and visualizations of the data to establish patterns of symmetry, skewness, and outliers. Will explore differences in the analysis of the alpha oscillations
5 secondary outcomes
Patient State Index (PSI)
Time frame: Up to 2 days post surgery
Electroencephalography (EEG) power
Time frame: During surgery
Burst suppression analysis
Time frame: During surgery
Burst suppression ratio
Time frame: During surgery
Coherence analysis
Time frame: During surgery
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 21 Nov 2023.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Juan P Cata, MD principal investigator
M.D. Anderson Cancer Center
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 Malignant Female Reproductive System Neoplasm, run by M.D. Anderson Cancer Center 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 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: finished, as of the sponsor's last update on 21 Nov 2023. 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?
Difference in the amplitude of alpha oscillations 15 minutes after incision (time frame: 15 minutes after incision). 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 21 Nov 2023.