Expired Study
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Houston, Texas 77030


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

2007-0637


NCT ID:

NCT00777192


Secondary ID:


Study Acronym:


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


Overall Status:

Terminated


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

M.D. Anderson Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Terminated at continuing review


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

509


Enrollment Type:

Actual


Overall Contact Information

Official Name:Xin Shelley Wang, MD. MPH
Principal Investigator
M.D. Anderson Cancer Center

Study Dates

Start Date:August 2008
Completion Date:December 27, 2018
Completion Type:Actual
Primary Completion Date:December 27, 2018
Primary Completion Type:Actual
Verification Date:May 2019
Last Changed Date:May 24, 2019
First Received Date:October 20, 2008

Study Outcomes

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

Study Interventions

Intervention Type:Behavioral
Name:Questionnaires
Description:20 Minute Questionnaires beginning Visit 1, to measure pain/other symptoms, mood, and quality of life
Arm Name:Symptoms in Colorectal Cancer

Study Arms

Study Arm Type:Other
Arm Name:Symptoms in Colorectal Cancer
Description:Colorectal Cancer Patients Receiving Oxaliplatin Chemotherapy

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:M.D. Anderson Cancer Center
Agency Class:Industry
Agency Type:Collaborator
Agency Name:AstraZeneca

Samples and Retentions

Sample 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.
Study Population: Patients having oxaliplatin chemotherapy as a treatment for colorectal cancer.
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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