Study of Chemotherapy Side Effects in Cancer Patients: Non-invasive Optical Measurements of the Brain

Currently there is no methodology that can assign a risk of development of chemo brain and thus, studies to understand how and why only some patients develop chemo brain along with studies of potential treatments face major hurdles. This study will define hemodynamic/optical parameters in normal individuals and cancer patients undergoing chemotherapy potentially identifying optical parameters that are associated with the development of chemo brain, leading to new insights into the origin of the chemo brain condition, and importantly potentially identifying parameters that may predict who will develop "chemo brain" in order to directing investigations of therapies.

Study Overview

• Status: Withdrawn
• Conditions: Signs and Symptoms
• Intervention / Treatment: Device: Diffuse optical spectroscopy and Near infrared spectroscopy

Detailed Description

The researcher can use Non-invasive optical imaging, diffuse optical spectroscopic imaging, measure various tissues and can determine chemo brain symptoms. Near infrared diffuse optical imaging is a real-time, non-invasive technique that measures hemodynamic variations based on changes in hemoglobin oxygenation. Tissue in general and the cerebral cortex surface in particular, are transparent to near infrared light.

Direct optical measurement of cerebral hemodynamic parameters is superior to systemic approaches that infer brain levels of hemoglobin. Optical imaging in conjunction with physiologic maneuvers measures vascular tone and reactivity and may permit early detection of changes in physiology that precede the onset of chemo brain symptoms. Since chemo brain specifically impacts working memory and executive function the optical imaging can measure the frontal cortical areas behind the forehead.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

primary care clinic, community sample

Description

Inclusion Criteria:

• have a histologically proven cancer.
• Planned initiation of chemotherapy
• age range between 18-70 years

Exclusion Criteria:

• have NO a histologically proven cancer.
• NO planned chemotherapy
• age less than 18 years

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diagnostic tool; Diffuse optical spectroscopy and Near infrared spectroscopy are non-invasive methods measure tissue hemodynamics in real time, direct quantitative information and insights treatment-associated toxicity.	Device: Diffuse optical spectroscopy and Near infrared spectroscopy; Diffuse optical spectroscopy and Near infrared spectroscopy are non-invasive methods measure tissue hemodynamics in real time, direct quantitative information and insights treatment-associated toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of brain tissues blood flow	Diffuse optical spectroscopy and Near infrared spectroscopy are non-invasive methods measure tissue hemodynamics in real time, direct quantitative information and insights treatment-associated toxicity.	6 months

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: Beckman Laser Institute University of California Irvine
• Investigators: Study Director: Bruce Tromberg, PhD, Beckman Laser Institute University of California Irvine; Principal Investigator: Edward Nelson, MD, Beckman Laser Institute University of California Irvine

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: January 12, 2011
• First Submitted That Met QC Criteria: January 13, 2011
• First Posted (Estimate): January 14, 2011

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Medical tool
• Other Study ID Numbers: 20086549