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Longitudinal Study of Symptoms in Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00777192
Recruitment Status : Terminated (Terminated at continuing review)
First Posted : October 22, 2008
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date October 20, 2008
First Posted Date October 22, 2008
Last Update Posted Date May 29, 2019
Actual Study Start Date August 2008
Actual Primary Completion Date December 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 17, 2009)		 Association between inflammatory cytokines and development of treatment-related symptom burden in colorectal cancer patients [ Time Frame: 5 Years ]
Original Primary Outcome Measures
 (submitted: October 20, 2008)		 To learn about the pain and/or other symptoms that patients may experience during and after treatment for colorectal cancer [ Time Frame: 5 Years ]
Change History
Current Secondary Outcome Measures
 (submitted: November 17, 2009)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: October 20, 2008)		 To learn how these symptoms may affect therapy [ Time Frame: 5 Years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Longitudinal Study of Symptoms in Colorectal Cancer
Official Title Prospective Study of Symptoms Related to Oxaliplatin-based Regimens in the Treatment of Colorectal Cancer
Brief 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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum and cell samples will also be collected during chemotherapy for analysis of cytokines and their relationship to symptom production.
Sampling Method Probability Sample
Study Population Patients having oxaliplatin chemotherapy as a treatment for colorectal cancer.
Condition Colorectal Cancer
Intervention Behavioral: Questionnaires
20 Minute Questionnaires beginning Visit 1, to measure pain/other symptoms, mood, and quality of life
Study Groups/Cohorts Symptoms in Colorectal Cancer
Colorectal Cancer Patients Receiving Oxaliplatin Chemotherapy
Intervention: Behavioral: Questionnaires
Publications * Wang XS, Shi Q, Dougherty PM, Eng C, Mendoza TR, Williams LA, Fogelman DR, Cleeland CS. Prechemotherapy Touch Sensation Deficits Predict Oxaliplatin-Induced Neuropathy in Patients with Colorectal Cancer. Oncology. 2016;90(3):127-35. doi: 10.1159/000443377. Epub 2016 Feb 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: May 13, 2019)		 509
Original Estimated Enrollment
 (submitted: October 20, 2008)		 125
Actual Study Completion Date December 27, 2018
Actual Primary Completion Date December 27, 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00777192
Other Study ID Numbers 2007-0637
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor M.D. Anderson Cancer Center
Collaborators AstraZeneca
Investigators
Principal Investigator: Xin Shelley Wang, MD. MPH M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date May 2019