NCT04593550

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

3.3 years

First QC Date

September 29, 2020

Last Update Submit

November 20, 2023

Conditions

Malignant Female Reproductive System Neoplasm

Outcome Measures

Primary Outcomes (1)

  • 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

    15 minutes after incision

Secondary Outcomes (5)

  • Patient State Index (PSI)

    Up to 2 days post surgery

  • Electroencephalography (EEG) power

    During surgery

  • Burst suppression analysis

    During surgery

  • Burst suppression ratio

    During surgery

  • Coherence analysis

    During surgery

Study Arms (1)

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.

Procedure: Biospecimen CollectionBehavioral: BrainCheck Cognitive AssessmentProcedure: Cognitive AssessmentProcedure: Electroencephalography

Interventions

Biospecimen CollectionPROCEDURE

Undergo collection of blood samples

Observational (BrainCheck, 3D-CAM, EEG)
BrainCheck Cognitive AssessmentBEHAVIORAL

Undergo cognitive function assessment BrainCheck

Also known as: BrainCheck
Observational (BrainCheck, 3D-CAM, EEG)
Cognitive AssessmentPROCEDURE

Undergo 3D-Confusion assessment

Observational (BrainCheck, 3D-CAM, EEG)
ElectroencephalographyPROCEDURE

Undergo EEG

Also known as: EEG, electroencephalogram
Observational (BrainCheck, 3D-CAM, EEG)

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with gynecologic cancers with or without history of preoperative chemotherapy

You may qualify if:

  • 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.

You may not qualify if:

  • Emergency surgery
  • ASA ≥ 4
  • Patients with extra-abdominal metastatic disease
  • Patients unable to complete preoperative and postoperative cognitive tests
  • Non-English-speaking patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

Mental Status and Dementia Tests

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Juan P Cata, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 20, 2020

Study Start

July 31, 2020

Primary Completion

November 17, 2023

Study Completion

November 17, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Locations

US(1)