Clinical trial · Observational
Chemotherapy-Related Changes in Neurocognitive Function and Symptoms in Colorectal Cancer Patients: A Pilot Study
NCT03683004CI-TRIAL-00070056completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- 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
Primary outcomes (16)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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: 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.
References
Publications (65)
- BACKGROUNDVardy 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 26527785
- BACKGROUNDVardy 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 25214544
- BACKGROUNDMyers 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 19136326
- BACKGROUNDVon 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 24183160
- BACKGROUNDMyers 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. PMID 24183161
- BACKGROUNDAskren 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. PMID 25138546
- BACKGROUNDJung 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.