Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy

Breast Cancer Clinical Trial

— CANTAB  

Official title:

Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy at Pre-Treatment, Post-Treatment, at Six Month Follow-Up, and Long-Term Follow-Ups

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01382082
• Other study ID #: URCC-10055
• Secondary ID: UG1CA189961U10CA
• Status: Enrolling by invitation
• Start date: July 14, 2011
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cognitive impairments in cancer patients represent an important clinical problem. Studies to date estimating prevalence of difficulties in memory, executive function, and attention deficits have been limited by small sample sizes and many have lacked healthy control groups. More information is needed on promising biomarkers and allelic variants that may help to determine the etiology of impairment, identify those most vulnerable to impairment, and develop interventions for these difficulties. This is a longitudinal observational study of cognitive function in breast cancer and lymphoma patients receiving chemotherapy to better understand the prevalence of cognitive difficulties (i.e., problems with memory, executive function, and attention) in these populations.

Other known NCT identifiers

• NCT01330225

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1432
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

Subjects Receiving Chemotherapy:

• Have a diagnosis of invasive breast cancer (stage I-IIIC) or intermediate or high-grade* lymphoma (*defined by the treating physician)
• Be scheduled to begin a course of chemotherapy
• Oral chemotherapy is acceptable
• Previous or concurrent treatment with hormones or biological response modifiers is acceptable. (Subjects receiving biological response modifiers only are not eligible).
• Be chemotherapy naïve
• Life expectancy greater than 10 months
• Be able to speak and read English
• Give written informed consent

Inclusion Criteria, Controls:

• Must be the same gender as the subject receiving chemotherapy
• Must be within 5 years of the age of the subject receiving chemotherapy
• Life expectancy greater than 10 months
• Be able to speak and read English
• Give written informed consent
• Must be willing to participate in the study for the entire period

Inclusion Criteria, Long-Term Followup Study:

• Must be a subject who had breast cancer, or control who was paired with that subject with breast cancer, who provided CANTAB data at any time-point during assessments 1 through 3. Exclusion Criteria:

Subjects Receiving Chemotherapy:

• Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness
• Must not be diagnosed with a neurodegenerative disease
• Must not have primary central nervous system (CNS) disease
• Must not have received chemotherapy in the past
• Must not be scheduled to receive concurrent radiation treatment
• Must not have metastatic disease (subjects with breast cancer)
• Must not be pregnant
• Must not be colorblind

Exclusion Criteria, Controls:

• Must not be currently hospitalized or have been hospitalized within the last year for a psychiatric illness
• Must not be diagnosed with a neurodegenerative disease
• Must not have primary CNS disease
• Must not have been diagnosed with cancer or previously have received chemotherapy
• Must not be pregnant or plan on becoming pregnant during the study period
• Must not be colorblind

Exclusion Criteria, Long-Term Followup Study:

• Must not have dementia or any severe neurodegenerative disease that would prohibit the ability to complete cognitive testing.
• Must not be colorblind

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphoma

Locations

Country	Name	City	State
United States	Columbus	Columbus	Ohio
United States	Columbus NCORP	Columbus	Ohio
United States	Dayton	Dayton	Ohio
United States	Dayton Community Oncology Program	Dayton	Ohio
United States	Heartland	Decatur	Illinois
United States	Hem Onc CNY	East Syracuse	New York
United States	Cancer Research Consortium of West Michigan	Grand Rapids	Michigan
United States	CRCWM	Grand Rapids	Michigan
United States	NCORP of the Carolinas	Greenville	South Carolina
United States	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Nevada	Las Vegas	Nevada
United States	Wisconsin NCORP	Marshfield	Wisconsin
United States	Aurora NCORP	Milwaukee	Wisconsin
United States	Metro Minnesota NCORP	Minneapolis	Minnesota
United States	Gulf South MU-NCORP	New Orleans	Louisiana
United States	Delaware/Christiana Care NCORP	Newark	Delaware
United States	Delaware/Christiana Care NCORP (CHRISTIANA)	Newark	Delaware
United States	Pacific Cancer Research Consortium Ncorp	Portland	Oregon
United States	PCRC	Portland	Oregon
United States	Kansas City Clinical Oncology Program	Prairie Village	Kansas
United States	Kansas City	Rochester	New York
United States	University of Rochester Cancer Center	Rochester	New York
United States	Metro Minnesota Community Oncology Research Consortium	Saint Louis Park	Minnesota
United States	Northwest (Virginia Mason)	Seattle	Washington
United States	Upstate Carolina	Spartanburg	South Carolina
United States	Wichita	Wichita	Kansas
United States	Wichita NCORP	Wichita	Kansas
United States	Novant Health Cancer Institute - Kernersville	Winston-Salem	North Carolina
United States	Southeast Clinical Oncology Research Program	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester NCORP Research Base	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	correlation of cognitive function with TNF alpha pathway biomarkers	serum assaying the change in the TNF pathway	change from pre to post chemotherapy and six month follow up
Primary	Short-term memory	Change in Short-term visual memory will be assessed by the computerized Delayed Matching to Sample (DMS) task.	Longitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controls
Secondary	Attention impairment	Change in attention will be assessed by the computerized Rapid Visual Information Processing (RVP) task.	Longitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controls
Secondary	Verbal recognition memory impairment	Change in Memory (verbal) will be assessed by the computerized Verbal Recognition Memory (VRM) Task.	Longitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controls
Secondary	Executive function impairment	Change in Executive function will be assessed by the computerized One Touch Stockings of Cambridge (OTS) planning task.	Longitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controls
Secondary	Self-report score	FACT-Cog change score	Longitudinal Mixed Model assessing change over time from pre to post chemotherapy and at 6 month follow-up assessing change from pre to post chemotherapy and pre to 6 months post-chemotherapy in patients compared to controls
Secondary	short term memory	Delayed match to sample score	8 and/or 10 years post-chemotherapy
Secondary	attention	Rapid Visual Processing speed score	8 and/or 10 years post-chemotherapy
Secondary	Self-report score	FACT-Cog	8 and/or 10 years post-chemotherapy