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

18 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

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

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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Association between inflammatory cytokines and development of treatment-related symptom burden in colorectal cancer patients

Outcome Time Frame:

5 Years

Safety Issue:


Principal Investigator

Xin Shelley Wang, MD. MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

August 2008

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • colon cancer
  • Cancers of the colon and rectum
  • Oxaliplatin
  • oxaliplatin chemotherapy
  • inflammatory cytokines
  • neurocognitive symptoms
  • neuropsychiatric symptoms
  • Colorectal Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030