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Neurological Effects of Chemotherapy and Radiation Therapy in Patients With Colon Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00410618
First Posted: December 13, 2006
Last Update Posted: December 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Arizona
  Purpose

RATIONALE: Learning about the long-term effects of chemotherapy and radiation therapy on brain function may help doctors plan cancer treatments.

PURPOSE: This clinical trial is looking at the neurological effects of chemotherapy and radiation therapy in patients with colon cancer.


Condition Intervention
Cognitive/Functional Effects Colorectal Cancer Long-term Effects Secondary to Cancer Therapy in Adults Procedure: cognitive assessment Procedure: magnetic resonance imaging Procedure: management of therapy complications

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Neurological Effects of Chemotherapy and Radiation Treatment: Colon Cancer

Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Nature and long-term ramifications of CNS injury as a result of cancer treatment

Secondary Outcome Measures:
  • Differences in cognitive measures and MRI data
  • Relationship between MRI measures and cognitive performance

Estimated Enrollment: 42
Study Start Date: April 2003
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Identify the nature and long-term ramifications of CNS injury as a result of cancer treatment in patients with colon cancer.

Secondary

  • Analyze differences in cognitive measures and MRI data in these patients.
  • Correlate MRI measures with cognitive performance in these patients.

OUTLINE: Patients undergo cognitive performance assessment and MRI.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Colon cancer
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of colon cancer
  • Received chemotherapy and radiotherapy for colon cancer

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00410618


Locations
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
Sponsors and Collaborators
University of Arizona
National Cancer Institute (NCI)
Investigators
Study Chair: Sheryl Reminger, MD University of Arizona
  More Information

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00410618     History of Changes
Other Study ID Numbers: HSCB0213
P50CA095060 ( U.S. NIH Grant/Contract )
P30CA023074 ( U.S. NIH Grant/Contract )
UARIZ-BSC-02-13 ( Other Identifier: University of Arizona )
First Submitted: December 11, 2006
First Posted: December 13, 2006
Last Update Posted: December 3, 2015
Last Verified: August 2012

Keywords provided by University of Arizona:
cognitive/functional effects
long-term effects secondary to cancer therapy in adults
recurrent colon cancer
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases