Longitudinal Study of Symptoms in Colorectal Cancer - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00777192

Purpose

The goal of this research study is to learn more about the pain and/or other symptoms that patients may experience during and after treatment for CRC and how these symptoms may affect therapy. Researchers also want to learn how differences in genes may affect the symptoms patients experience from cancer and cancer therapy.

Condition	Intervention
Colorectal Cancer	Behavioral: Questionnaires

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Prospective Study of Symptoms Related to Oxaliplatin-based Regimens in the Treatment of Colorectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Oxaliplatin

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Association between inflammatory cytokines and development of treatment-related symptom burden in colorectal cancer patients [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Primary afferent function in colorectal cancer patients receiving chemotherapy by quantitative sensory testing over time [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
Neurocognitive and neuropsychiatric symptoms in colorectal cancer patients [ Time Frame: Neuropsychological test battery at baseline and 3 + 6 month follow ups ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Serum and cell samples will also be collected during chemotherapy for analysis of cytokines and their relationship to symptom production.

Estimated Enrollment:	500
Study Start Date:	August 2008
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Symptoms in Colorectal Cancer Colorectal Cancer Patients Receiving Oxaliplatin Chemotherapy	Behavioral: Questionnaires 20 Minute Questionnaires beginning Visit 1, to measure pain/other symptoms, mood, and quality of life

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients having oxaliplatin chemotherapy as a treatment for colorectal cancer.

Criteria

Inclusion Criteria:

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. at least 12 months 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.
Patients >= 18 years old.
Patients who speak English or Spanish.

Exclusion Criteria:

Cohort 1 patients with a neuropathy score of 1 or greater on the NCI's Common Terminology Criteria (CTCv3.0).
Patients who do not understand the intent of the study.
Cohort 1 patients unable to use the interactive voice response (IVR) system due to physical limitations (e.g., hearing impairment).
Cohort 1 patients with a history of inflammatory bowel disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777192

Contacts

Contact: Xin Shelley Wang, MD, MPH	713-745-3470
Contact: Marilyn Morrissey, MPH	713/745-3590

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Xin Shelley Wang, MD, MPH 713-745-3504
Principal Investigator: Xin Shelley Wang, MD, MPH

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Xin Shelley Wang, MD. MPH

UT MD Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00777192 History of Changes
Other Study ID Numbers:	2007-0637
Study First Received:	October 20, 2008
Last Updated:	May 1, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

colon cancer
Cancers of the colon and rectum
Oxaliplatin
oxaliplatin chemotherapy

inflammatory cytokines
neurocognitive symptoms
neuropsychiatric symptoms

Additional relevant MeSH terms:

Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012