NCT01457287

Brief 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™.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2011

Completed
Last Updated

October 21, 2011

Status Verified

October 1, 2011

First QC Date

October 19, 2011

Last Update Submit

October 20, 2011

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Potential mechanisms leading to fatigue and/or cognitive decline

    2 Years

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients being treated for Colorectal cancer at participating centres

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Ian F Tannock, MD, PhD, DSc

    UHN/PMH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 19, 2011

First Posted

October 21, 2011

Study Start

October 1, 2003

Last Updated

October 21, 2011

Record last verified: 2011-10