NCT00777192

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
509

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2008

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2018

Completed
Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

10.4 years

First QC Date

October 20, 2008

Last Update Submit

May 24, 2019

Conditions

Colorectal Cancer

Keywords

colon cancerCancers of the colon and rectumOxaliplatinoxaliplatin chemotherapyinflammatory cytokinesneurocognitive symptomsneuropsychiatric symptoms

Outcome Measures

Primary Outcomes (1)

  • Association between inflammatory cytokines and development of treatment-related symptom burden in colorectal cancer patients

    5 Years

Secondary Outcomes (2)

  • Primary afferent function in colorectal cancer patients receiving chemotherapy by quantitative sensory testing over time

    5 Years

  • Neurocognitive and neuropsychiatric symptoms in colorectal cancer patients

    Neuropsychological test battery at baseline and 3 + 6 month follow ups

Study Arms (1)

Symptoms in Colorectal Cancer

Colorectal Cancer Patients Receiving Oxaliplatin Chemotherapy

Behavioral: Questionnaires

Interventions

QuestionnairesBEHAVIORAL

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

Symptoms in Colorectal Cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients having oxaliplatin chemotherapy as a treatment for colorectal cancer.

You may qualify if:

  • 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.
  • Patients \>= 18 years old.
  • Patients who speak English or Spanish.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 26882477DERIVED

Related Links

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.

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Xin Shelley Wang, MD. MPH

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2008

First Posted

October 22, 2008

Study Start

August 1, 2008

Primary Completion

December 27, 2018

Study Completion

December 27, 2018

Last Updated

May 29, 2019

Record last verified: 2019-05

Locations

US(1)