Study of Chemotherapy Side Effects in Cancer Patients: Non-invasive Optical Measurements of the Brain
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| First Received Date ICMJE | January 12, 2011 | ||||||||
| Last Updated Date | January 7, 2013 | ||||||||
| Start Date ICMJE | November 2008 | ||||||||
| Estimated Primary Completion Date | November 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
monitoring chemotherapy side effects [ Time Frame: 6 months ] [ Designated as safety issue: No ] symptoms associated with the chemobrain syndrome |
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| Original Primary Outcome Measures ICMJE |
chemotherapy side effects [ Time Frame: 1 day ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT01277276 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study of Chemotherapy Side Effects in Cancer Patients: Non-invasive Optical Measurements of the Brain | ||||||||
| Official Title ICMJE | Study of Chemotherapy Side Effects in Cancer Patients: Non-invasive Optical Measurements of the Brain | ||||||||
| Brief Summary | 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". |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | primary care clinic, community sample |
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| Condition ICMJE | Effects of Chemotherapy | ||||||||
| Intervention ICMJE | 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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| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||||||
| Estimated Enrollment ICMJE | 75 | ||||||||
| Estimated Completion Date | November 2015 | ||||||||
| Estimated Primary Completion Date | November 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01277276 | ||||||||
| Other Study ID Numbers ICMJE | LAMMP-30139; HS#2008-6549 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Montana Compton, University of California, Irvine | ||||||||
| Study Sponsor ICMJE | Montana Compton | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of California, Irvine | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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