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

NCT01277276 | Withdrawn

• 1 other identifier: 20086549
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Signs and Symptoms

Keywords

Medical tool

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Diffuse optical spectroscopy and Near infrared spectroscopy DEVICE

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.

Diagnostic tool

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic, community sample

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Irvine: lead
• Beckman Laser Institute University of California Irvine: collaborator

MeSH Terms

Conditions

Signs and Symptoms

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Edward Nelson, MD

  Beckman Laser Institute University of California Irvine

  PRINCIPAL INVESTIGATOR

• Bruce Tromberg, PhD

  Beckman Laser Institute University of California Irvine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Edward L. Nelson, M.D, Associate Professor of Medicine

Study Record Dates

• First Submitted: January 12, 2011
• First Posted: January 14, 2011
• Study Start: November 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: November 1, 2022

Record last verified: 2022-10