Chemotherapy-induced peripheral neuropathy
Conditions
Interventions
Model Development and Validation Cohort:None
Management plan effect verification cohort intervention group:Application of an intelligent clinical decision support system (CDSS)-supported end-to-end management protocol: baseline data entry before
during chemotherapy, the system automatically pushes personalized symptom monitoring plans and structured evidence-based intervention recommendation lists (e.g., health education, exercise prescriptio
research nurses perform assessments and record intervention implementation based on system prompts
if symptom escalation is detected during follow-up evaluation, the system dynamically adjusts risk level and recommended plan.
Management plan effect verification cohort control group:Receiving routine oncology care and CIPN management: symptom-driven assessment and management according to current clinical guidelines and phys
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Age >= 18 years; 2. Histopathologically confirmed malignant tumor, with a plan to receive at least four cycles of the aforementioned neurotoxic chemotherapy; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2; 4. Possess basic communication and comprehension abilities, provide informed consent, and voluntarily participate in this study. Validation of the Effects of the Full-Chain Management Protocol: 1. Pathologically confirmed malignant tumor; 2. Age >= 18 years; 3. Planned receipt of at least four cycles of neurotoxic chemotherapy (e.g., platinum-based agents, taxanes) as the first-line chemotherapy regimen; 4. ECOG performance status score of 0–2; 5. Possess basic communication abilities and provide informed consent.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Pre-existing moderate-to-severe peripheral neuropathy (Common Terminology Criteria for Adverse Events [CTCAE] grade >= 2) caused by other distinct etiologies prior to chemotherapy, such as diabetic peripheral neuropathy, alcoholic neuropathy, or cervical/lumbar compressive radiculopathy; 2. History of major neurological disorders, such as stroke, Parkinson’s disease, or multiple sclerosis; 3. Severe psychiatric disorders or cognitive impairment that preclude cooperation with questionnaire completion and assessments; 4. Life expectancy of less than 6 months. Verification of the Efficacy of the Full-Chain Management Protocol: 1. Presence of peripheral neuropathy of any etiology (e.g., due to diabetes or alcohol use) at baseline, assessed as CTCAE grade >= 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE); 2. Concurrent receipt of other treatments potentially associated with neurotoxicity; 3. Physical conditions that hinder the implementation of the intervention, such as active infections or ulcers of the hands or feet; 4. Comorbid severe organ failure; 5. Life expectancy of less than 6 months; 6. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of moderate to severe (>=Grade 2) CIPN assessed by NCI-CTCAE v5.0;Patient-reported quality of life; | — |
Secondary
| Measure | Time frame |
|---|---|
| CIPN symptom experience and functional limitation in daily activities;Balance function;Relative dose intensity (RDI) of chemotherapy;Unplanned treatment modification rate due to CIPN (including dose reduction rate, cycle delay rate, and early termination rate);Discriminative performance of prediction model;Calibration performance of prediction model;Clinical utility of prediction model;Usability score of CDSS;Clinical adherence indicators (completion rate and intervention execution rate);Intervention fidelity (coverage of systematic assessments and completion rate of core intervention components); | — |
Countries
China
Contacts
Public ContactYu Xinyan
Zhejiang Cancer Hospital
Outcome results
None listed