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


N/A
18 Years
70 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Cognitive Function

Outcome Description:

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) & Coghealthâ„¢.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Ian F Tannock, MD, PhD, DSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

UHN/PMH

Authority:

Canada: Ethics Review Committee

Study ID:

COIT10

NCT ID:

NCT01457287

Start Date:

October 2003

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

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