Imaging the Effects of R-CHOP and other Anthracycline containing Chemotherapy on Cognitive Function in Patients with high-grade lymphoma

Trial Purpose and Description

Trial Purpose

The study provides a critical opportunity to address the effects of R-CHOP and other anthracycline containing chemotherapy on brain and cognitive function as measured by fMRI. The results could serve as a benchmark to enhance the understanding of the central nervous system effects of R-CHOP and other anthracycline containing chemotherapy and the impact on quality of life of lymphoma survivors.

Participation Guidelines

Eligibility Criteria

Patients may not have any currently active second malignancy. Patients may not be receiving any investigational agents. Patients may not have had any prior chemotherapy for any malignancy. Patients may not have any significant cardiovascular disease (e.g. New York Heart Association or NYHA Class III or IV congestive heart failure, recent myocardial infarction, unstable angina, pacemaker), any significant liver disease (e.g. liver cirrhosis Child-Pugh B or C), any significant renal disease or any significant neurological disease. Those who have an axis-I psychiatric diagnosis or who are substance (excluding nicotine) dependent will not be recruited for the study (First et al., 1995). Patients will undergo a health questionnaire interview to rule out ineligibility for fMRI prior to the study. The mini-mental state examination (MMSE) will also be administered for all potential subjects to assess their basic cognitive functions (Folstein et al., 1975). Only subjects who score 25 and above (out of a score of 30=no impairment; Mitrushina and Satz, 1991) are eligible for this study.

Sponsor:

The William O Seery Foundation

Dates:

October 2010

Last Updated:

Study HIC#:

1009007419

Clinicaltrials.gov ID: Yale5915142