Colorectal CancerNCT03683004
Chemotherapy-Related Changes in Neurocognitive Function and Symptoms in Colorectal Cancer Patients: A Pilot Study
An observational study of Colorectal Cancer, run by University of Nebraska at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2018to 25 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CRC Diagnosis: Worse 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.
Who may be able to join
- CRC adenocarcinoma patients:
- Stage II/IV patients receiving adjuvant CTX (Ctx+ group)
- Stage I/III patients not receiving CTX (Ctx- group)
- Normal or corrected to normal vision (corrected far visual acuity of 20/50 or better)
- For demographically-matched healthy controls (HC group)
- Matched to patient receiving CTX on demographics: age (plus or minus 5 years, gender, race, menopausal status, and education (plus or minus 2 years)
- Normal or corrected-to-normal vision (corrected far visual acuity of 20/50 or better)
Who cannot join
- CRC patients:
- Cancer 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
- Demographically-matched healthy controls:
- CRC cancer diagnosis All exclusion criteria for CRC patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nerbaska Medical Center
Omaha, Nebraska, 68918
About this study
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).
Read the detailed description
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.
- Conditions
- Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CRC patients (Ctx+ group) | Postoperative CRC patients scheduled to begin CTX | |
| CRC patients (CT- group) | Postoperative CRC patients who do not receive CTX | |
| Healthy control group | Study participants that are demographically matched to CRC study patients and meet all inclusion criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Trails A baseline at 12 weeks and 24 weeks (Specific Aim 1)
Neurocognitive measure of processing speed; Completion time (milliseconds), where longer completion times are interpreted as slower processing speed
Measured: Change from baseline to 12 and 24 weeks
Change from Trails B baseline at 12 weeks and 24 weeks (Specific Aim 1)
Neurocognitive measure of executive functioning; Completion time (milliseconds) where larger differences in completion time are interpreted as slower executive functioning processes
Measured: Change from baseline to 12 weeks and 24 weeks
Change from Symbol Digit Modalities baseline at 12 weeks and 24 weeks (Specific Aim 1)
Neurocognitive measure of psychomotor speed; Total correct complete, where greater number completed is interpreted as faster psychomotor speed
Measured: Change from baseline to 12 weeks and 24 weeks
Change from Stroop baseline at 12 weeks and 24 weeks (Specific Aim 1)
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)
Measured: Change from baseline to 12 weeks and 24 weeks
Change from Auditory Verbal Learning Task baseline at 12 weeks and 24 weeks (Specific Aim 1)
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
Measured: Change from Baseline to 12 and 24 weeks
Change from Visual Search Performance baseline at 12 weeks and 24 weeks (Specific Aim IIa)
Measure of Response time (milliseconds), where longer response times are interpreted as slower processing speed and lower inhibitory control.
Measured: Change from baseline to 12 and 24 weeks
Change from Change Detection Performance baseline at 12 weeks and 24 weeks (Specific Aim IIa)
Measure of response accuracy, where larger response accuracies are interpreted as larger working memory capacity and higher inhibitory control.
Measured: Change from baseline to 12 and 24 weeks
Change from N2pc amplitude during visual search baseline at 12 weeks and 24 weeks (Specific Aim IIa)
Measure of attentional control. Larger amplitudes are interpreted as more resources allocated towards stimulus selection and poor attentional control
Measured: Change from baseline to 12 and 24 weeks
Change from Contralateral delay activity (CDA) amplitude change during task performance baseline at 12 weeks and 24 weeks (Specific Aim IIa)
Measure of working memory storage. Where larger amplitudes are interpreted as more resources allocated towards working memory storage.
Measured: Change from baseline to 12 and 24 weeks
Change from MRI white matter volume baseline at 12 weeks and 24 weeks (Specific Aim IIb)
Measure of white matter volume within executive function network
Measured: Change from baseline to 6 months (only CTx+ group)
Change from MRI Grey matter volume baseline at 12 weeks and 24 weeks (Specific Aim IIb)
Measure of grey matter volume within executive function network
Measured: Change from baseline to 6 months (only CTx+ group)
Change from Executive Functional Network functional connectivity baseline at 12 weeks and 24 weeks (Specific Aim IIb)
EFN function
Measured: Change from baseline to 6 months (only CTx+ group)
Change from M.D. Anderson Symptom Inventory-Gastro-Intestinal (MDASI-GI) baseline at 12 weeks and 24 weeks(Specific Aim III)
Measures co-occurring symptom severity and interference with function
Measured: Change from baseline to 12 weeks and 24 weeks
Change from Research And Development (RAND) Short Form-12 (SF-12) from baseline to 12 and 24 weeks (Specific Aim III)
Measures physical and mental functional status
Measured: Change from baseline to 12 weeks and 24 weeks
Change from Functional Assessment of Cancer Therapy- Cognitive (FACT-COG) at baseline to 12 and 24 weeks (Specific Aim III)
Self-perceives cognitive function
Measured: Change from baseline to12 weeks and 24 weeks
Change from Beck Depression Inventory (BDI) from baseline to 12 and 24 weeks (Specific Aim III)
Assesses depressive symptoms
Measured: Change from baseline to 12 and 24 weeks
Secondary outcomes (4)
Change from logMAR visual acuity baseline at 12 weeks and 24 weeks
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)
Measured: Change from baseline to 12 and 24 weeks
Change from logMAR contrast sensitivity baseline at 12 weeks and 24 weeks
Measures contrast sensitivity. Relatively lower logMAR values are interpreted as better contrast sensitivity.
Measured: Change from baseline to 12 and 24 weeks
Change from Frequency Doubling Technology baseline at 12 weeks and 24 weeks
Measures visual field loss. A binary (yes/no) variable where presence of visual field defect is coded as evidence of visual field loss
Measured: Change from baseline to 12 and 24 weeks
Change from Optical Coherence Tomography baseline at 12 weeks and 24 weeks
Measure of retinal nerve fiber layer (RNFL) thickness
Measured: Change from baseline to 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start22 Jan 2018
- Primary completion25 Nov 2020
- Study completion25 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (65)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann M Berger, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683004
- Sponsor's protocol ID
- 0228-17-EP
- Status last verified
- Sep 2023
- First submitted
- 5 Jul 2018
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26527785Vardy 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.
PubMed 25214544Myers 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.
PubMed 19136326Von 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.
PubMed 24183160Myers JS. Cancer- and chemotherapy-related cognitive changes: the patient experience. Semin Oncol Nurs. 2013 Nov;29(4):300-7. doi: 10.1016/j.soncn.2013.08.010.
PubMed 24183161Askren MK, Jung M, Berman MG, Zhang M, Therrien B, Peltier S, Ossher L, Hayes DF, Reuter-Lorenz PA, Cimprich B. Neuromarkers of fatigue and cognitive complaints following chemotherapy for breast cancer: a prospective fMRI investigation. Breast Cancer Res Treat. 2014 Sep;147(2):445-55. doi: 10.1007/s10549-014-3092-6. Epub 2014 Aug 21.
PubMed 25138546Jung MS, Zhang M, Askren MK, Berman MG, Peltier S, Hayes DF, Therrien B, Reuter-Lorenz PA, Cimprich B. Cognitive dysfunction and symptom burden in women treated for breast cancer: a prospective behavioral and fMRI analysis. Brain Imaging Behav. 2017 Feb;11(1):86-97. doi: 10.1007/s11682-016-9507-8.
PubMed 26809289Corbetta M, Shulman GL. Control of goal-directed and stimulus-driven attention in the brain. Nat Rev Neurosci. 2002 Mar;3(3):201-15. doi: 10.1038/nrn755.
PubMed 11994752Hopfinger JB, Buonocore MH, Mangun GR. The neural mechanisms of top-down attentional control. Nat Neurosci. 2000 Mar;3(3):284-91. doi: 10.1038/72999.
PubMed 10700262Wang L, Liu X, Guise KG, Knight RT, Ghajar J, Fan J. Effective connectivity of the fronto-parietal network during attentional control. J Cogn Neurosci. 2010 Mar;22(3):543-53. doi: 10.1162/jocn.2009.21210.
PubMed 19301995de Fockert J, Rees G, Frith C, Lavie N. Neural correlates of attentional capture in visual search. J Cogn Neurosci. 2004 Jun;16(5):751-9. doi: 10.1162/089892904970762.
PubMed 15200703Frick MA, Vachani CC, Hampshire MK, Bach C, Arnold-Korzeniowski K, Metz JM, Hill-Kayser CE. Survivorship after lower gastrointestinal cancer: Patient-reported outcomes and planning for care. Cancer. 2017 May 15;123(10):1860-1868. doi: 10.1002/cncr.30527. Epub 2017 Jan 5.
PubMed 28055110Arndt V, Merx H, Stegmaier C, Ziegler H, Brenner H. Quality of life in patients with colorectal cancer 1 year after diagnosis compared with the general population: a population-based study. J Clin Oncol. 2004 Dec 1;22(23):4829-36. doi: 10.1200/JCO.2004.02.018.
PubMed 15570086McCleary NJ, Odejide O, Szymonifka J, Ryan D, Hezel A, Meyerhardt JA. Safety and effectiveness of oxaliplatin-based chemotherapy regimens in adults 75 years and older with colorectal cancer. Clin Colorectal Cancer. 2013 Mar;12(1):62-9. doi: 10.1016/j.clcc.2012.09.001. Epub 2012 Oct 24.
PubMed 23102897Berger AM, Visovsky C, Hertzog M, Holtz S, Loberiza FR Jr. Usual and worst symptom severity and interference with function in breast cancer survivors. J Support Oncol. 2012 May-Jun;10(3):112-8. doi: 10.1016/j.suponc.2011.11.001. Epub 2012 Jan 24.
PubMed 22277573
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy-Related Changes in Neurocognitive Function and Symptoms in Colorectal Cancer Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT03683004
- Acronym / sponsor ID
- 0228-17-EP
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 25 Nov 2020 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CRC patients (Ctx+ group) | – | –Postoperative CRC patients scheduled to begin CTX |
| CRC patients (CT- group) | – | –Postoperative CRC patients who do not receive CTX |
| Healthy control group | – | –Study participants that are demographically matched to CRC study patients and meet all inclusion criteria |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CRC Diagnosis: Worse 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.
Key inclusion criteria (7 listed)
- Stage II/IV patients receiving adjuvant CTX (Ctx+ group)
- Stage I/III patients not receiving CTX (Ctx- group)
- Normal or corrected to normal vision (corrected far visual acuity of 20/50 or better)
- For demographically-matched healthy controls (HC group)
- Matched to patient receiving CTX on demographics: age (plus or minus 5 years, gender, race, menopausal status, and education (plus or minus 2 years)
Key exclusion criteria (4 listed)
- Cancer 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
- CRC cancer diagnosis All exclusion criteria for CRC patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Trails A baseline at 12 weeks and 24 weeks (Specific Aim 1)
Time frame: Change from baseline to 12 and 24 weeks
Neurocognitive measure of processing speed; Completion time (milliseconds), where longer completion times are interpreted as slower processing speed
Change from Trails B baseline at 12 weeks and 24 weeks (Specific Aim 1)
Time frame: Change from baseline to 12 weeks and 24 weeks
Neurocognitive measure of executive functioning; Completion time (milliseconds) where larger differences in completion time are interpreted as slower executive functioning processes
Change from Symbol Digit Modalities baseline at 12 weeks and 24 weeks (Specific Aim 1)
Time frame: Change from baseline to 12 weeks and 24 weeks
Neurocognitive measure of psychomotor speed; Total correct complete, where greater number completed is interpreted as faster psychomotor speed
Change from Stroop baseline at 12 weeks and 24 weeks (Specific Aim 1)
Time frame: Change from baseline to 12 weeks and 24 weeks
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)
Change from Auditory Verbal Learning Task baseline at 12 weeks and 24 weeks (Specific Aim 1)
Time frame: Change from Baseline to 12 and 24 weeks
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
Change from Visual Search Performance baseline at 12 weeks and 24 weeks (Specific Aim IIa)
Time frame: Change from baseline to 12 and 24 weeks
Measure of Response time (milliseconds), where longer response times are interpreted as slower processing speed and lower inhibitory control.
Change from Change Detection Performance baseline at 12 weeks and 24 weeks (Specific Aim IIa)
Time frame: Change from baseline to 12 and 24 weeks
Measure of response accuracy, where larger response accuracies are interpreted as larger working memory capacity and higher inhibitory control.
Change from N2pc amplitude during visual search baseline at 12 weeks and 24 weeks (Specific Aim IIa)
Time frame: Change from baseline to 12 and 24 weeks
Measure of attentional control. Larger amplitudes are interpreted as more resources allocated towards stimulus selection and poor attentional control
Change from Contralateral delay activity (CDA) amplitude change during task performance baseline at 12 weeks and 24 weeks (Specific Aim IIa)
Time frame: Change from baseline to 12 and 24 weeks
Measure of working memory storage. Where larger amplitudes are interpreted as more resources allocated towards working memory storage.
Change from MRI white matter volume baseline at 12 weeks and 24 weeks (Specific Aim IIb)
Time frame: Change from baseline to 6 months (only CTx+ group)
Measure of white matter volume within executive function network
Change from MRI Grey matter volume baseline at 12 weeks and 24 weeks (Specific Aim IIb)
Time frame: Change from baseline to 6 months (only CTx+ group)
Measure of grey matter volume within executive function network
Change from Executive Functional Network functional connectivity baseline at 12 weeks and 24 weeks (Specific Aim IIb)
Time frame: Change from baseline to 6 months (only CTx+ group)
EFN function
Change from M.D. Anderson Symptom Inventory-Gastro-Intestinal (MDASI-GI) baseline at 12 weeks and 24 weeks(Specific Aim III)
Time frame: Change from baseline to 12 weeks and 24 weeks
Measures co-occurring symptom severity and interference with function
Change from Research And Development (RAND) Short Form-12 (SF-12) from baseline to 12 and 24 weeks (Specific Aim III)
Time frame: Change from baseline to 12 weeks and 24 weeks
Measures physical and mental functional status
Change from Functional Assessment of Cancer Therapy- Cognitive (FACT-COG) at baseline to 12 and 24 weeks (Specific Aim III)
Time frame: Change from baseline to12 weeks and 24 weeks
Self-perceives cognitive function
Change from Beck Depression Inventory (BDI) from baseline to 12 and 24 weeks (Specific Aim III)
Time frame: Change from baseline to 12 and 24 weeks
Assesses depressive symptoms
4 secondary outcomes
Change from logMAR visual acuity baseline at 12 weeks and 24 weeks
Time frame: Change from baseline to 12 and 24 weeks
Change from logMAR contrast sensitivity baseline at 12 weeks and 24 weeks
Time frame: Change from baseline to 12 and 24 weeks
Change from Frequency Doubling Technology baseline at 12 weeks and 24 weeks
Time frame: Change from baseline to 12 and 24 weeks
Change from Optical Coherence Tomography baseline at 12 weeks and 24 weeks
Time frame: Change from baseline to 12 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Background: PubMed 26527785Vardy 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.
- Background: PubMed 25214544Vardy 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.
- Background: PubMed 19136326Myers 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.
- Background: PubMed 24183160Von 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.
- Background: PubMed 24183161Myers JS. Cancer- and chemotherapy-related cognitive changes: the patient experience. Semin Oncol Nurs. 2013 Nov;29(4):300-7. doi: 10.1016/j.soncn.2013.08.010.
- Background: PubMed 25138546Askren MK, Jung M, Berman MG, Zhang M, Therrien B, Peltier S, Ossher L, Hayes DF, Reuter-Lorenz PA, Cimprich B. Neuromarkers of fatigue and cognitive complaints following chemotherapy for breast cancer: a prospective fMRI investigation. Breast Cancer Res Treat. 2014 Sep;147(2):445-55. doi: 10.1007/s10549-014-3092-6. Epub 2014 Aug 21.
- Background: PubMed 26809289Jung MS, Zhang M, Askren MK, Berman MG, Peltier S, Hayes DF, Therrien B, Reuter-Lorenz PA, Cimprich B. Cognitive dysfunction and symptom burden in women treated for breast cancer: a prospective behavioral and fMRI analysis. Brain Imaging Behav. 2017 Feb;11(1):86-97. doi: 10.1007/s11682-016-9507-8.
- Background: PubMed 11994752Corbetta M, Shulman GL. Control of goal-directed and stimulus-driven attention in the brain. Nat Rev Neurosci. 2002 Mar;3(3):201-15. doi: 10.1038/nrn755.
- Background: PubMed 10700262Hopfinger JB, Buonocore MH, Mangun GR. The neural mechanisms of top-down attentional control. Nat Neurosci. 2000 Mar;3(3):284-91. doi: 10.1038/72999.
- Background: PubMed 19301995Wang L, Liu X, Guise KG, Knight RT, Ghajar J, Fan J. Effective connectivity of the fronto-parietal network during attentional control. J Cogn Neurosci. 2010 Mar;22(3):543-53. doi: 10.1162/jocn.2009.21210.
- Background: PubMed 15200703de Fockert J, Rees G, Frith C, Lavie N. Neural correlates of attentional capture in visual search. J Cogn Neurosci. 2004 Jun;16(5):751-9. doi: 10.1162/089892904970762.
- Background: PubMed 28055110Frick MA, Vachani CC, Hampshire MK, Bach C, Arnold-Korzeniowski K, Metz JM, Hill-Kayser CE. Survivorship after lower gastrointestinal cancer: Patient-reported outcomes and planning for care. Cancer. 2017 May 15;123(10):1860-1868. doi: 10.1002/cncr.30527. Epub 2017 Jan 5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann M Berger, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Trails A baseline at 12 weeks and 24 weeks (Specific Aim 1) (time frame: Change from baseline to 12 and 24 weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03683004, which also lists 65 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.