We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Longitudinal Study of Symptoms in Colorectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00777192
First Posted: October 22, 2008
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
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.

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:


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 ]

Secondary Outcome Measures:
  • Primary afferent function in colorectal cancer patients receiving chemotherapy by quantitative sensory testing over time [ Time Frame: 5 Years ]
  • Neurocognitive and neuropsychiatric symptoms in colorectal cancer patients [ Time Frame: Neuropsychological test battery at baseline and 3 + 6 month follow ups ]

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
Actual Study Start Date: August 2008
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients having oxaliplatin chemotherapy as a treatment for colorectal cancer.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777192


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
AstraZeneca
Investigators
Principal Investigator: Xin Shelley Wang, MD. MPH M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00777192     History of Changes
Other Study ID Numbers: 2007-0637
First Submitted: October 20, 2008
First Posted: October 22, 2008
Last Update Posted: February 23, 2017
Last Verified: February 2017

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