Colorectal CancerNCT01457287
A Longitudinal Investigation of Cognitive Function in Colorectal Cancer Patients
An observational study of Colorectal Cancer, run by University Health Network, Toronto.
Trial summary
This is a prospective, longitudinal, controlled study of cognitive function and fatigue in patients with apparently localized CRC treated with adjuvant or neoadjuvant chemotherapy. In addition to following each patient over time (i.e. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to not given
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients being treated for Colorectal cancer at participating centres
Who may be able to join
- Aged 18-70 years old
- Performance Status (PS) of 0-1 on the ECOG Performance Scale
- Life expectancy of at least 12 months
- Full recovery from any post operative sequelae
- Adequate hepatic function as documented by a serum bilirubin < 18umol/L, and LFTs within 1.5X normal range
- Patients with histologically confirmed, stage B or C colorectal cancer (CRC), who have undergone surgical resection and are about to commence chemotherapy.
- Patients due to receive neoadjuvant chemotherapy prior to surgery are also eligible.
Who cannot join
- Any major pre-existing psychiatric history or dementia, alcohol abuse, or currently using a psychotropic medication that might lead to cognitive problems, other than short acting benzodiazepines for nausea or sleep
- Any evidence of metastatic disease. If there is clinical suspicion of CNS involvement patients must have brain imaging (MRI or CT scan) prior to recruitment.
- Ongoing sepsis or uncontrolled infection, including HIV infection
- Pre-existing neurological condition likely to interfere with ability to perform cognitive testing
- Any other severe co-morbidity which, in the judgement of the investigator, would make the patient inappropriate for entry into this study
- Active cancer within the last 5 years other than squamous or basal cell carcinoma of the skin or cervical cancer in situ (except for CRC)
- Previous history of chemotherapy
- Minimal English skills such that subjects would be unable to follow simple, written English instructions and to read questionnaires of a grade 8 standard with the help of a research assistant.
About this study
Official title: Cognitive Function and Fatigue in Cancer Patients After Chemotherapy: A Longitudinal Controlled Study in Patients With Colorectal Cancer
This is a prospective, longitudinal, controlled study of cognitive function and fatigue in patients with apparently localized CRC treated with adjuvant or neoadjuvant chemotherapy. In addition to following each patient over time (i.e. acting as their own control), a separate control group will consist of patients with early stage CRC (Stage A or B) who have had surgical resection of their tumour, but who do not require adjuvant chemotherapy, or patients with stage C CRC who have declined chemotherapy.
Also included is a smaller sub-study of patients with limited metastatic CRC who are treated with more toxic chemotherapy
To compare changes in cognitive function, as compared to baseline assessment, of patients with CRC who do, or do not, receive 5FU-based chemotherapy. The primary measures of cognitive function are the High Sensitivity Cognitive Screen (HSCS) \& Coghealth™.
- Conditions
- Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function
To compare changes in cognitive function, as compared to baseline assessment, of patients with CRC who do, or do not, receive 5FU-based chemotherapy. The primary measures of cognitive function are the High Sensitivity Cognitive Screen (HSCS) \& Coghealth™.
Measured: 2 years
Secondary outcomes (1)
Potential mechanisms leading to fatigue and/or cognitive decline
To evaluate potential mechanisms leading to fatigue and/or cognitive decline. To measure hemoglobin, serum levels of sex hormones (LH, FSH, estradiol (in women), testosterone (in men)), selected cytokines (TNF-α, IL-1 \& IL-6), homocysteine, markers of blood coagulation (thrombin-anti-thrombin (TAT), prothrombin fragment 1 \& 2, and d-dimers), and the apolipoprotein E genotype
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Ian F Tannock, MD, PhD, DSc, Principal investigator, UHN/PMH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457287
- Sponsor's protocol ID
- COIT10
- Status last verified
- Oct 2011
- First submitted
- 19 Oct 2011
- Last updated
- 21 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Function and Fatigue in Cancer Patients After Chemotherapy: A Longitudinal Controlled Study in Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01457287
- Acronym / sponsor ID
- COIT10
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Oct 2003
- First posted
- 21 Oct 2011 (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.
This is a prospective, longitudinal, controlled study of cognitive function and fatigue in patients with apparently localized CRC treated with adjuvant or neoadjuvant chemotherapy. In addition to following each patient over time (i.e. acting as their own control), a separate control group will consist of patients with early stage CRC (Stage A or B) who have had surgical resection of their tumour, but who do not require adjuvant chemotherapy, or patients with stage C CRC who have declined chemotherapy.
Also included is a smaller sub-study of patients with limited metastatic CRC who are treated with more toxic chemotherapy
To compare changes in cognitive function, as compared to baseline assessment, of patients with CRC who do, or do not, receive 5FU-based chemotherapy. The primary measures of cognitive function are the High Sensitivity Cognitive Screen (HSCS) \& Coghealth™.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being treated for Colorectal cancer at participating centres
Key inclusion criteria (7 listed)
- Aged 18-70 years old
- Performance Status (PS) of 0-1 on the ECOG Performance Scale
- Life expectancy of at least 12 months
- Full recovery from any post operative sequelae
- Adequate hepatic function as documented by a serum bilirubin < 18umol/L, and LFTs within 1.5X normal range
Key exclusion criteria (8 listed)
- Any major pre-existing psychiatric history or dementia, alcohol abuse, or currently using a psychotropic medication that might lead to cognitive problems, other than short acting benzodiazepines for nausea or sleep
- Any evidence of metastatic disease. If there is clinical suspicion of CNS involvement patients must have brain imaging (MRI or CT scan) prior to recruitment.
- Ongoing sepsis or uncontrolled infection, including HIV infection
- Pre-existing neurological condition likely to interfere with ability to perform cognitive testing
- Any other severe co-morbidity which, in the judgement of the investigator, would make the patient inappropriate for entry into this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive Function
Time frame: 2 years
To compare changes in cognitive function, as compared to baseline assessment, of patients with CRC who do, or do not, receive 5FU-based chemotherapy. The primary measures of cognitive function are the High Sensitivity Cognitive Screen (HSCS) \& Coghealth™.
1 secondary outcome
Potential mechanisms leading to fatigue and/or cognitive decline
Time frame: 2 Years
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 21 Oct 2011.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Ian F Tannock, MD, PhD, DSc principal investigator
UHN/PMH
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by University Health Network, Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Cognitive Function (time frame: 2 years). 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 21 Oct 2011.