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

This study has been withdrawn prior to enrollment.
(no participant enrolled)
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01277276
First received: January 12, 2011
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

The researcher at UCI Beckman Laser Institute develop Near infrared spectroscopy (NIRS) and diffuse optical spectroscopy (DOS) are non-invasive optical imaging methods (NIDOI). The researcher want to use NIDOI to define hemodynamic/optical parameters in cancer patients undergoing chemotherapy potentially identifying optical parameters that are associated with the development of chemobrain, leading to new insights into the origin of the chemobrain condition, and importantly potentially identifying parameters that may predict who will develop "chemobrain".


Condition Intervention
Effects of Chemotherapy
Device: Near infrared diffuse optical imaging (NIDOI)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Chemotherapy Side Effects in Cancer Patients: Non-invasive Optical Measurements of the Brain

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • monitoring chemotherapy side effects [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    symptoms associated with the chemobrain syndrome


Enrollment: 0
Study Start Date: November 2008
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Near infrared diffuse optical imaging (NIDOI)
    NIDOI to observe diminished at rest tissue oxygen perfusion chemobrain associated symptoms
    Other Name: NIDOI developed at UCI Beckman Laser Institute
Detailed Description:

The researcher study about the integration of NIDOI and psychometric testing with initiation of active cytotoxic chemotherapeutic treatment.

The researcher study about the feasibility of NIDOI analysis in patients undergoing initial cytotoxic chemotherapy for cancer and to explore associations in these optical parameters between patient reported outcomes reflective of disruption of quality of life (QOL) and chemobrain-mild cognitive impairment and to test the research hypothesis is that among cancer patients, those who develop chemobrain symptoms will experience a greater mean reduction in brain tissue oxygen saturation than those who do not.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic, community sample

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277276

Locations
United States, California
Beckman Laser Institute Medical clinic
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Investigators
Principal Investigator: Edward Nelson, MD Beckman Laser Institute University of California Irvine
Principal Investigator: Bruce Tromberg, PhD Beckman Laser Institute University of California Irvine
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01277276     History of Changes
Other Study ID Numbers: LAMMP-30139; HS#2008-6549
Study First Received: January 12, 2011
Last Updated: August 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
chemobrain

ClinicalTrials.gov processed this record on August 28, 2014