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Study Summary
No. 2007-0637:.......Colorectal......Xin Shelley Wang......Symptom Research
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Study Summary Title
Study Summary
Number:
2007-0637
Study Title:Prospective Study of Symptoms Related to Oxaliplatin-based Regimens in the Treatment of Colorectal Cancer
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Physician New Patient Referral
Name:Xin Shelley WangPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Symptom ResearchReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-3470
Contact us about clinical trials
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General Information
Disease Group:ColorectalSupported By:Astra Zeneca
Phase of Study:N/AReturn
Visit:
Patients will have a clinic visit at every cycle of chemotherapy that is
scheduled by treating physicians.
Treatment
Agents:
QuestionnaireHome Care:No.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
no required hospital stay.
Description/
Intervention:
The goal of this research study is to learn about the pain and/or other
symptoms that patients may experience during and after treatment for colorectal
cancer and how these symptoms may affect therapy.
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Study Objectives / Outcomes
1. To identify the association between inflammatory cytokines (e.g., IL-1, IL-6, and TNF-alpha) and the development of treatment-related symptom burden (e.g., pain, neuropathy, fatigue, cognitive impairment, and other symptoms) in patients with colorectal cancer. Our central hypothesis is that increases in the levels of serum proinflammatory cytokines in response to oxaliplatin-based cancer treatment will be associated with the development of a cluster of symptoms in patients with colorectal cancer, and that TNF-a in particular will be highly correlated with painful neuropathy.

2. To track primary afferent function by quantitative sensory testing over time in patients with colorectal cancer who are receiving chemotherapy. We hypothesize that patients being treated with oxaliplatin who develop neuropathic pain will exhibit reduction in primary afferent fiber function reduction as reflected in the sensory testing measures.

3. To characterize neurocognitive and neuropsychiatric symptoms in patients with colorectal cancer using a neuropsychological test battery at baseline and at selected follow-up points. We hypothesize that approximately one third of patients with colorectal cancer will develop depression and impairments of memory, executive function, and fine-motor speed during treatment.

4. To evaluate the major symptom burden reported by patients with colorectal cancer (CRC) at least 1 year, but no more than 5 years, post-diagnosis.

5. To analyze genetic variation from inflammation and other symptom-related genes with regard to risk of developing high symptom burden from cancer and therapy in patients with CRC.

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Study Status Information
Study Activation / Registration Date:06/23/2008
IRB Review and Approval Date:06/23/2008
Study Type:Other
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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. at least 12 months 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.

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Links
Registration Number: NCT00777192
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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