Clinical trial NCT00777192: Longitudinal Study of Symptoms in Colorectal Cancer
Official title: Prospective Study of Symptoms Related to Oxaliplatin-based Regimens in the Treatment of Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colorectal Cancer
Keywords: colon cancer
Cancers of the colon and rectum
Oxaliplatin
oxaliplatin chemotherapy
inflammatory cytokines
neurocognitive symptoms
neuropsychiatric symptoms
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2008-10-22
Enrollment: 509
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients having oxaliplatin chemotherapy as a treatment for 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.

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.

Primary outcomes:
measure: Association between inflammatory cytokines and development of treatment-related symptom burden in colorectal cancer patients
timeFrame: 5 Years
Secondary outcomes:
measure: Primary afferent function in colorectal cancer patients receiving chemotherapy by quantitative sensory testing over time
timeFrame: 5 Years
measure: Neurocognitive and neuropsychiatric symptoms in colorectal cancer patients
timeFrame: Neuropsychological test battery at baseline and 3 + 6 month follow ups
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Xin Shelley Wang, MD. MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.