Clinical trial NCT01382082: Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Breast Cancer
Lymphoma
Keywords: cognitive function
memory
attention
breast cancer
lymphoma
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-06-27
Enrollment: 1432
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: During enrollment, the groups will be balanced on age and gender. Controls of the same age and gender as the subject receiving chemotherapy will be enrolled at the same time.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Short-term memory
timeFrame: 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 outcomes:
measure: Attention impairment
timeFrame: 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
measure: Verbal recognition memory impairment
timeFrame: 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
measure: Executive function impairment
timeFrame: 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
measure: Self-report score
timeFrame: 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
measure: short term memory
timeFrame: 8 and/or 10 years post-chemotherapy
measure: attention
timeFrame: 8 and/or 10 years post-chemotherapy
measure: Self-report score
timeFrame: 8 and/or 10 years post-chemotherapy
Other outcomes:
measure: correlation of cognitive function with TNF alpha pathway biomarkers
timeFrame: change from pre to post chemotherapy and six month follow up
Locations:
city: Newark
country: United States
facility: Delaware/Christiana Care NCORP
state: Delaware
city: Newark
country: United States
facility: Delaware/Christiana Care NCORP (CHRISTIANA)
state: Delaware
city: Decatur
country: United States
facility: Heartland
state: Illinois
city: Prairie Village
country: United States
facility: Kansas City Clinical Oncology Program
state: Kansas
city: Wichita
country: United States
facility: Wichita NCORP
state: Kansas
city: Wichita
country: United States
facility: Wichita
state: Kansas
city: New Orleans
country: United States
facility: Gulf South MU-NCORP
state: Louisiana
city: Grand Rapids
country: United States
facility: Cancer Research Consortium of West Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: CRCWM
state: Michigan
city: Minneapolis
country: United States
facility: Metro Minnesota NCORP
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro Minnesota Community Oncology Research Consortium
state: Minnesota
city: Las Vegas
country: United States
facility: CCOP - Nevada Cancer Research Foundation
state: Nevada
city: Las Vegas
country: United States
facility: Nevada
state: Nevada
city: East Syracuse
country: United States
facility: Hem Onc CNY
state: New York
city: Rochester
country: United States
facility: Kansas City
state: New York
city: Rochester
country: United States
facility: University of Rochester Cancer Center
state: New York
city: Winston-Salem
country: United States
facility: Novant Health Cancer Institute - Kernersville
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeast Clinical Oncology Research Program
state: North Carolina
city: Columbus
country: United States
facility: Columbus NCORP
state: Ohio
city: Columbus
country: United States
facility: Columbus
state: Ohio
city: Dayton
country: United States
facility: Dayton Community Oncology Program
state: Ohio
city: Dayton
country: United States
facility: Dayton
state: Ohio
city: Portland
country: United States
facility: Pacific Cancer Research Consortium Ncorp
state: Oregon
city: Portland
country: United States
facility: PCRC
state: Oregon
city: Greenville
country: United States
facility: NCORP of the Carolinas
state: South Carolina
city: Spartanburg
country: United States
facility: Upstate Carolina
state: South Carolina
city: Seattle
country: United States
facility: Northwest (Virginia Mason)
state: Washington
city: Marshfield
country: United States
facility: Wisconsin NCORP
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora NCORP
state: Wisconsin
Study officials:
affiliation: University of Rochester
name: Michelle C. Janelsins, PhD
role: STUDY_CHAIR
References:
citation: Kleckner AS, Kleckner IR, Culakova E, Shayne M, Belcher EK, Gudina AT, Williams AM, Onitilo AA, Hopkins JO, Gross H, Mustian KM, Peppone LJ, Janelsins MC. The association between cancer-related fatigue and diabetes from pre-chemotherapy to 6 months post-chemotherapy. Support Care Cancer. 2022 Sep;30(9):7655-7663. doi: 10.1007/s00520-022-07189-x. Epub 2022 Jun 9.
citation: Gilmore N, Mohile S, Lei L, Culakova E, Mohamed M, Magnuson A, Loh KP, Maggiore R, Belcher E, Conlin A, Weiselberg L, Ontko M, Janelsins M. The longitudinal relationship between immune cell profiles and frailty in patients with breast cancer receiving chemotherapy. Breast Cancer Res. 2021 Feb 5;23(1):19. doi: 10.1186/s13058-021-01388-w.