Clinical trial · Observational
Longitudinal Study of Symptoms in Colorectal Cancer
Prospective Study of Symptoms Related to Oxaliplatin-based Regimens in the Treatment of Colorectal Cancer
NCT00777192CI-TRIAL-00038827terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated at continuing review
Summary
Brief summary (as posted)
The goal of this research study is to learn more about the pain and/or other symptoms that patients may experience within five years from CRC diagnosis. Researchers also want to learn how genetic differences may affect the symptoms patients experience from cancer and cancer therapy.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Symptoms in Colorectal Cancer
- description
- Colorectal Cancer Patients Receiving Oxaliplatin Chemotherapy
- interventionNames
- Behavioral: Questionnaires
Primary outcomes (1)
- measure
- Association between inflammatory cytokines and development of treatment-related symptom burden in colorectal cancer patients
- timeFrame
- 5 Years
Secondary outcomes (2)
- measure
- Primary afferent function in colorectal cancer patients receiving chemotherapy by quantitative sensory testing over time
- timeFrame
- 5 Years
- measure
- Neurocognitive and neuropsychiatric symptoms in colorectal cancer patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with colorectal cancer meeting one of the following criteria: 1. naive to oxaliplatin or to any microtubule stabilizing agents (e.g. Taxol, Abraxane, Ixabepilone) but scheduled for combined oxaliplatine chemotherapy (longitudinal study cohort 1); or 2. during first 5 years from colorectal cancer diagnosis (cross-sectional study cohort). This second cohort may include patients with colorectal cancer from the original 12-month study (the longitudinal cohort), both those who completed the study and those who dropped out. It may also include new patients who did not participate in the longitudinal phase of the study. 2. Patients \>= 18 years old. 3. Patients who speak English or Spanish. Exclusion Criteria: 1. Cohort 1 patients with a neuropathy score of 1 or greater on the NCI's Common Terminology Criteria (CTCv3.0). 2. Patients who do not understand the intent of the study. 3. Cohort 1 patients unable to use the interactive voice response (IVR) system due to physical limitations (e.g., hearing impairment). 4. Cohort 1 patients with a history of inflammatory bowel disease.
References
Publications (1)
- DERIVEDWang XS, Shi Q, Dougherty PM, Eng C, Mendoza TR, Williams LA, Fogelman DR, Cleeland CS. Prechemotherapy Touch Sensation Deficits Predict Oxaliplatin-Induced Neuropathy in Patients with Colorectal Cancer. Oncology. 2016;90(3):127-35. doi: 10.1159/000443377. Epub 2016 Feb 17. PMID 26882477