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Chemotherapy-Related Changes in Neurocognitive Function and Symptoms in Colorectal Cancer Patients: A Pilot Study

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ClinicalTrials.gov Identifier: NCT03683004
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Ann Berger, PhD RN AOCN FAAN, University of Nebraska

Brief 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. 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).

Condition or disease
Colorectal Cancer

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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chemotherapy-Related Changes in Neurocognitive Function and Symptoms in Colorectal Cancer Patients: A Pilot Study
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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


Secondary Outcome Measures :
  1. Change from logMAR visual acuity baseline at 12 weeks and 24 weeks [ Time Frame: Change from baseline to 12 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)

  2. Change from logMAR contrast sensitivity baseline at 12 weeks and 24 weeks [ Time Frame: Change from baseline to 12 and 24 weeks ]
    Measures contrast sensitivity. Relatively lower logMAR values are interpreted as better contrast sensitivity.

  3. Change from Frequency Doubling Technology baseline at 12 weeks and 24 weeks [ Time Frame: Change from baseline to 12 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

  4. Change from Optical Coherence Tomography baseline at 12 weeks and 24 weeks [ Time Frame: Change from baseline to 12 and 24 weeks ]
    Measure of retinal nerve fiber layer (RNFL) thickness



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

CRC Treatment:

Capecetibine (Cape); FOLF(Folinic acid and 5-FU); Cape-OX (Capecitabine and Oxaliplatin); FOLFOX(Oxaliplatin with FOLF). Adjuvant therapy is given over a 6-month period. For stage II disease, there is no overall survival benefit with adjuvant chemotherapy in low risk patients; in high risk patients, adjuvant treatment may be considered with either a fluoropyrimide alone or in combination with oxaliplatin. For stage III disease, there is an overall survival advantage using FOLFOX or Cape-OX.

Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683004


Contacts
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Contact: Ann Berger, PhD 402-559-4957 aberger@unmc.edu
Contact: David E Anderson, PhD 402-559-6870 david.anderson@unmc.edu

Locations
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United States, Nebraska
University of Nerbaska Medical Center Recruiting
Omaha, Nebraska, United States, 68106
Contact: Ann Berger, PhD         
Sponsors and Collaborators
University of Nebraska
Investigators
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Principal Investigator: Ann M Berger, PhD University of Nebraska

Publications:

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Responsible Party: Ann Berger, PhD RN AOCN FAAN, Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT03683004     History of Changes
Other Study ID Numbers: 228-17-EP
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases