Neurotoxicity Syndromes
Conditions
Keywords
Chemotherapy, Peripheral Neuropathy
Brief summary
To study the risk prediction of chemotherapy-induced peripheral neuropathy (CIPN) by the clinical bioinformatics and genomic profile.
Detailed description
This is a prospective, observational, cohort study, monitoring the chemotherapy-induced peripheral neurotoxicity by traditional clinical scales, neurological examinations, and semi-quantitative assessments. Moreover, all the genetic changes will be analyzed by next generation sequencing and we will try to identify relevant variants in individuals who suffer from chemotherapy-induced neurotoxicity.
Interventions
OTHERQuestionnaires
EORTC CIPN20 and EQ-5D-3L
PROCEDUREPeripheral nervous system examination
nerve conduction velocity (NCV), quantitative sensory test (QST), and nerve excitability test (NET)
GENETICWhole Genome Sequence
Genetic Test : 10 mL blood will be collected in Blood Sample Collection
Sponsors
National Cheng-Kung University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed epithelial ovarian cancer, endometrial cancer or adenocarcinoma of colon or rectum 2. Pathological stage I\~IV for ovarian cancer, stage II\~IV endometrial cancer or stage III \& high risk stage II for colorectal cancer 3. Scheduled to receive adjuvant Paclitaxel/Carboplatin for ovarian or endometrial cancer, or mFOLFOX6 for colorectal cancer 4. Age ≥ 20 years old 5. ECOG Performance status 0-1 6. Adequate organ function Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L WBC ≥ 3.0 x 109/L Platelet count ≥ 100 x 109/L Hemoglobin ≥ 9 g/dL Hepatic: Total bilirubin level ≤ 1.0 x UNL AST and ALT ≤ 3.0 x UNL Renal: Creatinine level ≤ 1.5 mg/dL in men, ≤1.4 mg/dL in women; or Estimated CCr ≥ 60 mL/min (CCr is estimated by Cockcroft-Gault formula, as appendix III). 7. Negative pregnancy test for women of childbearing potential only 8. Patient willing to provide blood sample for research purposes 9. Written informed consent
Exclusion criteria
1. Prior treatment with neurotoxic chemotherapy, such as oxaliplatin, cisplatin, carboplatin, taxanes or vinca alkaloids 2. Receiving chemotherapy within 6 months 3. History of allergy to 5-FU or LV 4. Pre-existing peripheral neuropathy of any grade 5. A family history of a genetic or familial neuropathy 6. Active uncontrolled infection 7. Significant medical diseases, such as unstable angina, acute or recent myocardial infarction (\<6 months before enrollment), COPD with frequent exacerbation, uncontrolled hypertension, ore cent CVA (\<6 months before enrollment) 8. Poor compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events occurring after chemotherapy based on genomic profiling | up to 2 years after chemotherapy |
Secondary
| Measure | Time frame |
|---|---|
| Changes in quality-of-life measured by EORTC CIPN20 | up to 2 years after chemotherapy |
| Changes in quality-of-life measured by EQ-5D-3L | up to 2 years after chemotherapy |
| Change from Baseline in nerve conduction velocity (NCV) | up to 2 years after chemotherapy |
| Change from Baseline in quantitative sensory test (QST) | up to 2 years after chemotherapy |
| Change from Baseline in nerve excitability test (NET) | up to 2 years after chemotherapy |
| Relapse-free survival | up to 5 years after chemotherapy |
| Overall Survival | up to 5 years after chemotherapy |
Countries
Taiwan
Contacts
STUDY_CHAIRMeng-Ru Shen, PHD
National Cheng Kung University
Outcome results
None listed