Cognitive/Functional EffectsNCT00410618
Neurological Effects of Chemotherapy and Radiation Therapy in Patients With Colon Cancer
An observational study of Cognitive/Functional Effects and Colorectal Cancer, run by University of Arizona at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cognitive/Functional Effects, Colorectal Cancer, Long-term Effects Secondary to Cancer Therapy in Adults
- What is being tested?
- cognitive assessment, magnetic resonance imaging and management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Aug 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Colon cancer
DISEASE CHARACTERISTICS:
- Diagnosis of colon cancer
- Received chemotherapy and radiotherapy for colon cancer
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724-5024
About this study
Official title: Neurological Effects of Chemotherapy and Radiation Treatment: Colon Cancer
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.
Read the 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.
- Conditions
- Cognitive/Functional Effects, Colorectal Cancer, Long-term Effects Secondary to Cancer Therapy in Adults
- Being tested
- cognitive assessment, magnetic resonance imaging, management of therapy complications
- Keywords
- 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
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive assessmentProcedure or surgery
magnetic resonance imagingProcedure or surgery
management of therapy complicationsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Nature and long-term ramifications of CNS injury as a result of cancer treatment
Secondary outcomes (2)
Differences in cognitive measures and MRI data
Relationship between MRI measures and cognitive performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2006 (estimated)
- Study startApr 2003
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive/Functional EffectsStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sheryl Reminger, MD, Study chair, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410618
- Sponsor's protocol ID
- HSCB0213
- Other IDs
- P50CA095060, P30CA023074, UARIZ-BSC-02-13
- Status last verified
- Aug 2012
- First submitted
- 11 Dec 2006
- Last updated
- 6 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurological Effects of Chemotherapy and Radiation Treatment: Colon Cancer
- ClinicalTrials.gov ID
- NCT00410618
- Acronym / sponsor ID
- HSCB0213
- Conditions
- Cognitive/Functional Effects, Colorectal Cancer, Long-term Effects Secondary to Cancer Therapy in Adults
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2003
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 13 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Colon cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive assessment | Procedure or surgery | – |
| magnetic resonance imaging | Procedure or surgery | – |
| management of therapy complications | Procedure or surgery | – |
Primary outcome
Nature and long-term ramifications of CNS injury as a result of cancer treatment
2 secondary outcomes
Differences in cognitive measures and MRI data
Relationship between MRI measures and cognitive performance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheryl Reminger, MD study chair
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive/Functional Effects and Colorectal Cancer, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nature and long-term ramifications of CNS injury as a result of cancer treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.