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This study has been withdrawn prior to enrollment.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

January 12, 2011
August 7, 2013
November 2008
February 2013   (final data collection date for primary outcome measure)
monitoring chemotherapy side effects [ Time Frame: 6 months ] [ Designated as safety issue: No ]
symptoms associated with the chemobrain syndrome
chemotherapy side effects [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01277276 on ClinicalTrials.gov Archive Site
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Study of Chemotherapy Side Effects in Cancer Patients: Non-invasive Optical Measurements of the Brain
Study of Chemotherapy Side Effects in Cancer Patients: Non-invasive Optical Measurements of the Brain

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".

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

primary care clinic, community sample

Effects of Chemotherapy
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01277276
LAMMP-30139; HS#2008-6549
No
Montana Compton, University of California, Irvine
Montana Compton
Not Provided
Principal Investigator: Edward Nelson, MD Beckman Laser Institute University of California Irvine
Principal Investigator: Bruce Tromberg, PhD Beckman Laser Institute University of California Irvine
University of California, Irvine
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP