Cognitive Functioning and Quality of Life in CNS Lymphoma

Lymphoma Clinical Trial

Official title:

Cognitive Functioning and Quality of Life in CNS Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581737
• Other study ID #: 00-083
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: March 2, 2012
• Start date: July 2000
• Est. completion date: August 2009

Study information

• Verified date: March 2012
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate several aspects of thinking abilities including attention and memory, and quality of life in patients who were diagnosed with and treated for Primary CNS Lymphoma (PCNSL), and are in remission of their disease. The findings of this study may help us understand whether this disease and its treatment may have affected some patients' thinking skills, and may provide important information that can be used to develop programs to improve the quality of life of patients with PCNSL.

This research will also study whether persons having particular types of genes involved in the metabolism of methionine (5-methyltetrahydrofolate-homocysteine S-methyltransferase-MTR, MTFH reductase-MTFHR, transcobalamin 2-Tc2), and apolipoprotein E (APOE) are more likely to have delayed adverse effects after treatment for their tumors. The findings of this study may help us understand whether this disease and its treatment may have affected some patients' thinking skills, and whether this may be related to having certain genes.

Description:

The incidence of primary central nervous system lymphoma (PCNSL) has increased threefold in immunocompetent populations in recent years. Improvements in treatment, particularly involving combined modality therapy with chemotherapy and radiotherapy have been shown to augment patient survival with a median disease-free period of about 40 months. However, the combination of these two modalities often increases the risk for delayed neurotoxicity. There is a paucity of studies that have assessed neuropsychological functioning and quality of life in patients with PCNSL. The majority of studies reported performance status and survival rates, but systematic cognitive evaluations were only seldom included. Unfortunately, relying only on these variables does not adequately assess the more subtle cognitive impairments that most patients with brain tumors experience. Neuropsychological difficulties often interfere with disease free patients' ability to function at premorbid levels at work and at home. A study including neuropsychological evaluations of a relatively large group of patients with PCNSL who received combined modality treatments, and are in remission from their disease is planned. A follow-up assessment also will be performed in order to monitor performance over a specified period of time. The proposed study will also test the hypotheses that: (1) the presence of polymorphisms that influence methionine metabolism places PCNSL patients treated with chemotherapy alone or in combination with radiotherapy at risk for developing treatment-induced white matter disease and cognitive dysfunction; (2) the possession of the apolipoprotein E (APOE) є-4 allele is associated with the development of cognitive difficulties following treatment for PCNSL. Research in order to better understand the incidence, extent, and severity of treatment-induced neuropsychological impairments in patients with PCNSL is of utmost importance, given the recent increase in both the number of cases diagnosed and longterm survival. It is likely to provide valuable information regarding specific cognitive domains that should be addressed in the development of strategies for cognitive rehabilitation or other interventions that may be appropriate. The findings of this study will also be relevant for comparison with ongoing and future research investigating the potential neurocognitive sequelae of alternative treatment modalities for PCNSL (e.g., high-dose chemotherapy followed by peripheral blood progenitor cell (PBPC) transplant).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of and treatment for PCNSL

• Disease in remission at the time of testing, as defined by negative MRI and/or CSF cytology, and ocular exam if initially positive

• English speaking

Exclusion Criteria:

• patients who are medically unstable

• patients with severe, decompensated psychiatric disorders

• patients with a pre-existing neurological condition other than the designated illness (e. g., head trauma)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Central Nervous System Lymphoma
• Lymphoma

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The goal of this study is to examine the neurobehavioral functioning of PCNSL survivors who received radiation and chemotherapy treatments, and are in remission from their disease.		2 years	No
Secondary	Examine the delayed effects of whole-brain radiation and chemotherapy on several aspects of cognitive functioning, and quality of life. Also, perform a follow-up evaluation in order to monitor neurocognitive functioning over a specified period of time.		2 years	No

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