A Longitudinal Investigation of Cognitive Function in Colorectal Cancer Patients

Colorectal Cancer Clinical Trial

Official title:

Cognitive Function and Fatigue in Cancer Patients After Chemotherapy: A Longitudinal Controlled Study in Patients With Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457287
• Other study ID #: COIT10
• Status: Completed
• Phase: N/A
• First received: October 19, 2011
• Last updated: October 20, 2011
• Start date: October 2003

Study information

• Verified date: October 2011
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical 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. 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™.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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™.	2 years	No
Secondary	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-a, 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	2 Years	No