Longitudinal Study of Symptoms in Colorectal Cancer



Status:Active, not recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/24/2018
Start Date:August 2008
End Date:August 2020

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Prospective Study of Symptoms Related to Oxaliplatin-based Regimens in the Treatment of Colorectal Cancer

The goal of this research study is to learn more about the pain and/or other symptoms that
patients may experience within five years from CRC diagnosis. Researchers also want to learn
how genetic differences may affect the symptoms patients experience from cancer and cancer
therapy.

If you agree to take part in this study, you will complete 5 questionnaires during a
regularly scheduled visit. The questionnaires are designed to measure pain and other
symptoms, your mood, and your quality of life.

You will also give a tissue sample by inserting a cotton tipped swab into your mouth and
rubbing firmly against the inside of your cheek or underneath your lower or upper lip for
about 1 minute at the most.

Completing the 5 questionnaires and the swab sample should take about 30 minutes.

Length of Study:

After you complete the questionnaires and the swab sample collection, your active
participation in this study will be over.

This is an investigational study.

Up to 500 patients will take part in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Patients with colorectal cancer meeting one of the following criteria: 1. naive to
oxaliplatin or to any microtubule stabilizing agents (e.g. Taxol, Abraxane,
Ixabepilone) but scheduled for combined oxaliplatine chemotherapy (longitudinal study
cohort 1); or 2. during first 5 years from colorectal cancer diagnosis
(cross-sectional study cohort). This second cohort may include patients with
colorectal cancer from the original 12-month study (the longitudinal cohort), both
those who completed the study and those who dropped out. It may also include new
patients who did not participate in the longitudinal phase of the study.

2. Patients >= 18 years old.

3. Patients who speak English or Spanish.

Exclusion Criteria:

1. Cohort 1 patients with a neuropathy score of 1 or greater on the NCI's Common
Terminology Criteria (CTCv3.0).

2. Patients who do not understand the intent of the study.

3. Cohort 1 patients unable to use the interactive voice response (IVR) system due to
physical limitations (e.g., hearing impairment).

4. Cohort 1 patients with a history of inflammatory bowel disease.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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mi
from
Houston, TX
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