Clinical trial · Observational
Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- subjects with breast cancer
- label
- subjects with lymphoma
- label
- subjects without cancer
Primary outcomes (1)
- 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
- description
- Change in Short-term visual memory will be assessed by the computerized Delayed Matching to Sample (DMS) task.
Secondary outcomes (7)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDKleckner 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. PMID 35678881
- DERIVEDGilmore 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. PMID 33546731