Longitudinal Study of Symptoms in Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00777192
• Other study ID #: 2007-0637
• Status: Terminated
• Start date: August 2008
• Est. completion date: December 27, 2018

Study information

• Verified date: May 2019
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 509
• Est. completion date: December 27, 2018
• Est. primary completion date: December 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Questionnaires
20 Minute Questionnaires beginning Visit 1, to measure pain/other symptoms, mood, and quality of life

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between inflammatory cytokines and development of treatment-related symptom burden in colorectal cancer patients		5 Years
Secondary	Primary afferent function in colorectal cancer patients receiving chemotherapy by quantitative sensory testing over time		5 Years
Secondary	Neurocognitive and neuropsychiatric symptoms in colorectal cancer patients		Neuropsychological test battery at baseline and 3 + 6 month follow ups

External Links

•   University of Texas MD Anderson Cancer Center Website