Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-03-11 @ 1:02 AM
Study NCT ID:
NCT03683004
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2018-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chemotherapy-Related Changes in Neurocognitive Function and Symptoms in Colorectal Cancer Patients: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2018-07-05', 'studyFirstSubmitQcDate': '2018-09-20', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Trails A baseline at 12 weeks and 24 weeks (Specific Aim 1)', 'timeFrame': 'Change from baseline to 12 and 24 weeks', 'description': 'Neurocognitive measure of processing speed; Completion time (milliseconds), where longer completion times are interpreted as slower processing speed'}, {'measure': 'Change from Trails B baseline at 12 weeks and 24 weeks (Specific Aim 1)', 'timeFrame': 'Change from baseline to 12 weeks and 24 weeks', 'description': 'Neurocognitive measure of executive functioning; Completion time (milliseconds) where larger differences in completion time are interpreted as slower executive functioning processes'}, {'measure': 'Change from Symbol Digit Modalities baseline at 12 weeks and 24 weeks (Specific Aim 1)', 'timeFrame': 'Change from baseline to 12 weeks and 24 weeks', 'description': 'Neurocognitive measure of psychomotor speed; Total correct complete, where greater number completed is interpreted as faster psychomotor speed'}, {'measure': 'Change from Stroop baseline at 12 weeks and 24 weeks (Specific Aim 1)', 'timeFrame': 'Change from baseline to 12 weeks and 24 weeks', 'description': 'Neurocognitive measure of inhibitory control; Total number completed, where greater number completed is interpreted as better inhibitory control.Interference scores are obtained to estimate inhibitory control, where more negative values are interpreted as lower inhibitory control (estimated by subtracting expected performance from observed performance in color-word condition)'}, {'measure': 'Change from Auditory Verbal Learning Task baseline at 12 weeks and 24 weeks (Specific Aim 1)', 'timeFrame': 'Change from Baseline to 12 and 24 weeks', 'description': 'Neurocognitive measure of verbal memory; Total number recalled (immediate), where greater number immediately recalled is interpreted as better verbal short-term memory. Total number recalled (delayed), where greater number recall following delay is interpreted as better verbal long-term memory'}, {'measure': 'Change from Visual Search Performance baseline at 12 weeks and 24 weeks (Specific Aim IIa)', 'timeFrame': 'Change from baseline to 12 and 24 weeks', 'description': 'Measure of Response time (milliseconds), where longer response times are interpreted as slower processing speed and lower inhibitory control.'}, {'measure': 'Change from Change Detection Performance baseline at 12 weeks and 24 weeks (Specific Aim IIa)', 'timeFrame': 'Change from baseline to 12 and 24 weeks', 'description': 'Measure of response accuracy, where larger response accuracies are interpreted as larger working memory capacity and higher inhibitory control.'}, {'measure': 'Change from N2pc amplitude during visual search baseline at 12 weeks and 24 weeks (Specific Aim IIa)', 'timeFrame': 'Change from baseline to 12 and 24 weeks', 'description': 'Measure of attentional control. Larger amplitudes are interpreted as more resources allocated towards stimulus selection and poor attentional control'}, {'measure': 'Change from Contralateral delay activity (CDA) amplitude change during task performance baseline at 12 weeks and 24 weeks (Specific Aim IIa)', 'timeFrame': 'Change from baseline to 12 and 24 weeks', 'description': 'Measure of working memory storage. Where larger amplitudes are interpreted as more resources allocated towards working memory storage.'}, {'measure': 'Change from MRI white matter volume baseline at 12 weeks and 24 weeks (Specific Aim IIb)', 'timeFrame': 'Change from baseline to 6 months (only CTx+ group)', 'description': 'Measure of white matter volume within executive function network'}, {'measure': 'Change from MRI Grey matter volume baseline at 12 weeks and 24 weeks (Specific Aim IIb)', 'timeFrame': 'Change from baseline to 6 months (only CTx+ group)', 'description': 'Measure of grey matter volume within executive function network'}, {'measure': 'Change from Executive Functional Network functional connectivity baseline at 12 weeks and 24 weeks (Specific Aim IIb)', 'timeFrame': 'Change from baseline to 6 months (only CTx+ group)', 'description': 'EFN function'}, {'measure': 'Change from M.D. Anderson Symptom Inventory-Gastro-Intestinal (MDASI-GI) baseline at 12 weeks and 24 weeks(Specific Aim III)', 'timeFrame': 'Change from baseline to 12 weeks and 24 weeks', 'description': 'Measures co-occurring symptom severity and interference with function'}, {'measure': 'Change from Research And Development (RAND) Short Form-12 (SF-12) from baseline to 12 and 24 weeks (Specific Aim III)', 'timeFrame': 'Change from baseline to 12 weeks and 24 weeks', 'description': 'Measures physical and mental functional status'}, {'measure': 'Change from Functional Assessment of Cancer Therapy- Cognitive (FACT-COG) at baseline to 12 and 24 weeks (Specific Aim III)', 'timeFrame': 'Change from baseline to12 weeks and 24 weeks', 'description': 'Self-perceives cognitive function'}, {'measure': 'Change from Beck Depression Inventory (BDI) from baseline to 12 and 24 weeks (Specific Aim III)', 'timeFrame': 'Change from baseline to 12 and 24 weeks', 'description': 'Assesses depressive symptoms'}], 'secondaryOutcomes': [{'measure': 'Change from logMAR visual acuity baseline at 12 weeks and 24 weeks', 'timeFrame': 'Change from baseline to 12 and 24 weeks', 'description': 'Measures visual acuity. Relatively lower logMAR values are interpreted as better visual acuity (estimated as log transformed estimate of visual acuity with respect to deviation from standard 20/20)'}, {'measure': 'Change from logMAR contrast sensitivity baseline at 12 weeks and 24 weeks', 'timeFrame': 'Change from baseline to 12 and 24 weeks', 'description': 'Measures contrast sensitivity. Relatively lower logMAR values are interpreted as better contrast sensitivity.'}, {'measure': 'Change from Frequency Doubling Technology baseline at 12 weeks and 24 weeks', 'timeFrame': 'Change from baseline to 12 and 24 weeks', 'description': 'Measures visual field loss. A binary (yes/no) variable where presence of visual field defect is coded as evidence of visual field loss'}, {'measure': 'Change from Optical Coherence Tomography baseline at 12 weeks and 24 weeks', 'timeFrame': 'Change from baseline to 12 and 24 weeks', 'description': 'Measure of retinal nerve fiber layer (RNFL) thickness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '26527785', 'type': 'BACKGROUND', 'citation': 'Vardy JL, Dhillon HM, Pond GR, Rourke SB, Bekele T, Renton C, Dodd A, Zhang H, Beale P, Clarke S, Tannock IF. Cognitive Function in Patients With Colorectal Cancer Who Do and Do Not Receive Chemotherapy: A Prospective, Longitudinal, Controlled Study. J Clin Oncol. 2015 Dec 1;33(34):4085-92. doi: 10.1200/JCO.2015.63.0905. Epub 2015 Nov 2.'}, {'pmid': '25214544', 'type': 'BACKGROUND', 'citation': 'Vardy J, Dhillon HM, Pond GR, Rourke SB, Xu W, Dodd A, Renton C, Park A, Bekele T, Ringash J, Zhang H, Burkes R, Clarke SJ, Tannock IF. Cognitive function and fatigue after diagnosis of colorectal cancer. Ann Oncol. 2014 Dec;25(12):2404-2412. doi: 10.1093/annonc/mdu448. Epub 2014 Sep 11.'}, {'pmid': '19136326', 'type': 'BACKGROUND', 'citation': 'Myers JS. A comparison of the theory of unpleasant symptoms and the conceptual model of chemotherapy-related changes in cognitive function. Oncol Nurs Forum. 2009 Jan;36(1):E1-10. doi: 10.1188/09.ONF.E1-E10.'}, {'pmid': '24183160', 'type': 'BACKGROUND', 'citation': 'Von Ah D, Storey S, Jansen CE, Allen DH. Coping strategies and interventions for cognitive changes in patients with cancer. Semin Oncol Nurs. 2013 Nov;29(4):288-99. doi: 10.1016/j.soncn.2013.08.009.'}, {'pmid': '24183161', 'type': 'BACKGROUND', 'citation': 'Myers JS. 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Epub 2023 Mar 24.'}]}, 'descriptionModule': {'briefSummary': 'Cancer treatments have successfully improved cancer outcomes but frequently negatively impact quality of life in cancer survivors. In particular, chemotherapy (CTX) has been associated with impaired cognitive abilities such as concentration and memory. The goal is to investigate the neural mechanisms of chemotherapy-related cognitive impairment (CRCI) using an interdisciplinary translational approach. Previous research in this area lacks diversity in studied cancer populations and treatments focusing primarily on breast cancer and provides limited understanding of how CRCI emerges from changes in neural structure, function, and connectivity. To overcome these limitations, this feasibility/pilot study aims to investigate CRCI in patients with colorectal cancer (CRC).', 'detailedDescription': 'A growing public health and oncology nursing concern is the likelihood of colorectal cancer (CRC) survivors experiencing decline in long-term physical and mental functional status following cancer diagnosis and treatment. Prior to receiving treatment, cognitive impairment in processing speed, spatial working memory, and verbal memory has been noted in 45% of CRC patients relative to 15% of healthy controls (HC). Following adjuvant chemotherapy, cognitive function is more impaired in CRC patients who received chemotherapy (Ctx+ group) compared to CRC patients not receiving chemotherapy (Ctx- group) and HC participants. These studies show: (1) CRC patients are at a high risk for cognitive impairment and (2) Ctx+ patients are more likely to decline in cognitive function during treatment. These cancer and chemotherapy-related changes in cognitive function have been associated with several quality of life factors, including physiological and concurrent symptoms, and physical and mental functional status. In contrast, the neural mechanisms of cognitive impairment in CRC patients is related to changes in the Executive Function Network (EFN). The EFN promotes long-range communication between frontal and parietal cortical regions, and is associated with attentional control processes. The empirical goals studying CRC patients are two-fold: (1) Develop a core set of cognitive function, event related potential (ERP) measures from electroencephalogram (EEG), and resting-state functional magnetic resonance imaging (rsfMRI) measures to elucidate the relationship between impaired attentional control and EFN dysfunction and (2) Increase understanding of the link between neurocognitive impairment with concurrent symptom severity and impact on functioning. The investigators propose a longitudinal, prospective cohort pilot design to study post-operative CRC patients scheduled to begin adjuvant chemotherapy (Ctx+ group). Comparison groups will include post-operative CRC patients not receiving chemotherapy (Ctx- group) and healthy controls demographically matched to Ctx+ participants (HC group). All participants (N=60; 20 per group) will complete an additional 1-hour study visits at baseline and 24-weeks to collect rsfMRI measurements Ctx+ patients will complete baseline assessment after surgery but before starting chemotherapy, CTx- patients will complete baseline assessments 4-6 weeks after surgery and HC after matched and consented.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'CRC Diagnosis:\n\nWorse prognosis includes presentation with complete colon obstruction, perforation, T4 tumor fewer than 12 lymph nodes examined, elevated CEA levels pre-or post-surgery, positive margins, and peri-neural, lymphatic or venous invasion. Molecular markers also correlate with the aggressiveness of colon cancer.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCRC adenocarcinoma patients:\n\n* Stage II/IV patients receiving adjuvant CTX (Ctx+ group)\n* Stage I/III patients not receiving CTX (Ctx- group)\n* Normal or corrected to normal vision (corrected far visual acuity of 20/50 or better)\n\nFor demographically-matched healthy controls (HC group)\n\n* Matched to patient receiving CTX on demographics: age (plus or minus 5 years, gender, race, menopausal status, and education (plus or minus 2 years)\n* Normal or corrected-to-normal vision (corrected far visual acuity of 20/50 or better)\n\nExclusion Criteria:\n\nCRC patients:\n\nCancer diagnosis/treatment in last 3 yrs. in addition to CRC (exceptionpatients with localized skin cancer) Prior chemotherapy within 1 year for CRC Cognitive impairment (MMSE score \\< 25) prior to baseline assessment\n\nDemographically-matched healthy controls:\n\nCRC cancer diagnosis All exclusion criteria for CRC patients.'}, 'identificationModule': {'nctId': 'NCT03683004', 'briefTitle': 'Chemotherapy-Related Changes in Neurocognitive Function and Symptoms in Colorectal Cancer Patients: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Chemotherapy-Related Changes in Neurocognitive Function and Symptoms in Colorectal Cancer Patients: A Pilot Study', 'orgStudyIdInfo': {'id': '0228-17-EP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CRC patients (Ctx+ group)', 'description': 'Postoperative CRC patients scheduled to begin CTX'}, {'label': 'CRC patients (CT- group)', 'description': 'Postoperative CRC patients who do not receive CTX'}, {'label': 'Healthy control group', 'description': 'Study participants that are demographically matched to CRC study patients and meet all inclusion criteria'}]}, 'contactsLocationsModule': {'locations': [{'zip': '68918', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nerbaska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Ann M Berger, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}