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View Clinical Trial (Medical Research Study)


Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy at Pre-Treatment, Post-Treatment, and at Six Month Follow-Up

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City:   Rochester
State:   New York
Zip Code:   14642
Conditions:   Anxiety Disorder - Breast Cancer - Cognitive/Functional Effects - Fatigue - Lymphoma - Lymphoproliferative Disorder - Small Intestine Cancer
Purpose:   RATIONALE: Learning about the effects of chemotherapy on brain function may help doctors plan the best treatment. PURPOSE: This clinical trial is studying changes in brain function in patients with breast cancer or lymphoma who are receiving chemotherapy.
Study Summary:   OBJECTIVES: Primary - To quantify the difference in memory impairment (via psychometrically validated computerized CANTAB test) in breast cancer (females receiving anthracycline and non-anthracycline regimens) or lymphoma patients (males and females receiving chemotherapy) compared with a control comparison group of the same age and gender at pre-treatment and post-treatment. Secondary - To quantify the difference in verbal memory impairment (via psychometrically validated computerized CANTAB test) in breast cancer (females receiving anthracycline and non-anthracycline regimens) and lymphoma patients (males and females receiving chemotherapy) compared with a control comparison group of the same age and gender at pre-treatment and post-treatment. - To quantify the difference in executive function impairment (via psychometrically validated computerized CANTAB test) in breast cancer (females receiving anthracycline and non-anthracycline regimens) and lymphoma patients (males and females receiving chemotherapy) compared with a control comparison group of the same age and gender at pre-treatment and post-treatment. - To quantify the difference in attention impairment (via psychometrically validated computerized CANTAB test) in breast cancer (females receiving anthracycline and non-anthracycline regimens) and lymphoma patients (males and females receiving chemotherapy) compared with a control comparison group of the same age and gender at pre-treatment and post-treatment. Tertiary - To quantify the difference in memory, executive function, and attention impairments at six-month follow-up in breast cancer and lymphoma patients compared to a control comparison group of the same age and gender at pre-treatment and post-treatment. (Exploratory) - To quantify the difference in memory, executive function, and attention impairments by validated standard neuropsychological testing and phone-based cognitive assessments. (Exploratory) - To quantify the difference in memory, executive function, and attention impairments by single item self-report questions, and validated self-report instruments (i.e., BRIEF-A, FACT-Cog). (Exploratory) - To identify the relationships between performance on self-report, phone-based cognitive testing, standard neuropsychological testing, and computerized CANTAB testing in breast cancer and lymphoma patients compared with a control comparison group of the same age and gender at pre-treatment, post-treatment, and at six-month follow-up. (Exploratory) - To provide data on the associations of inflammatory molecules (i.e., IL-6, MCP-1, IL-8, IL-1β, PGE2) with cognitive functioning in breast cancer and lymphoma patients compared with a control comparison group of the same age and gender at pre-treatment, post-treatment, and at six-month follow-up. (Exploratory) - To provide data on the associations of SNPs (e.g. APOE, COMT, MRE) with cognitive functioning in breast cancer and lymphoma patients compared with a control comparison group of the same age and gender at pre-treatment, post-treatment, and at six-month follow-up. (Exploratory) OUTLINE: This is a multicenter study. Patients and controls are assessed for memory, executive functions, and attention using the Cambridge Neuropsychological Test Automated Battery (CANTAB) computerized testing, the Wide Range Achievement Test-Third Edition (WRAT-4), the Hopkins Verbal Learning and Memory Test-Revised (HVLT-R), the Trail Making Test (Comprehensive Trail Making Test Trails 1 and 5), the Controlled Oral Word Association Test (COWA), the Functional Assessment of Cancer Therapy with Cognition (FACT-Cog), and the MD Anderson Symptom Inventory at baseline, within 1 month after completion of therapy, and then after 6 months. Patients and controls also are assessed by telephone and self-report symptoms on quality of life, anxiety, fatigue, sleep, and physical activity. Demographics and clinical data are also collected. Serum, plasma and whole blood samples are collected for correlative studies.
Criteria:   DISEASE CHARACTERISTICS: - Have a diagnosis of invasive breast cancer (stage I-IIIC) or intermediate or high-grade* lymphoma (*defined by the treating physician) - Be chemotherapy naive - Be scheduled to begin a course of chemotherapy - Oral chemotherapy is acceptable - Previous or concurrent treatment with hormones or biological response modifiers is acceptable - Patients receiving biological response modifiers only are not eligible - Must not have primary CNS disease - Must not have metastatic disease (patients with breast cancer) NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: - Life expectancy greater than 10 months - Be able to speak and read English - Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness - Must not be diagnosed with a neurodegenerative disease - Must not be pregnant or plan on becoming pregnant during study period - Must not be colorblind - Controls must also meet the following criteria: - Must be within 5 years of the age of the patient receiving chemotherapy - Must be the same gender as the patient receiving chemotherapy - Must be willing to participate in the study for the entire period - Must not have been diagnosed with cancer PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Must not have received chemotherapy in the past - Must not be scheduled to receive concurrent radiation treatment
NCT ID:   NCT01330225
Primary Contact:   Study Chair
Michelle C. Janelsins, PhD
University of Rochester

Backup Contact:   N/A
Location Contact:   Rochester, New York 14642
United States

Michelle C. Janelsins, PhD
Phone: 585-275-5513

Site Status: Recruiting

Click here to see:
  • Clinical trials for Breast Cancer in Rochester, New York
  • Clinical trials for Lymphoma in Rochester, New York

Data Source:   ClinicalTrials.gov
Date Processed:   May 24, 2013
Modifications to this listing:   Only selected fields are shown, please use the link below to view all information about this clinical trial.
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