To Study the Individual Variants of Chemotherapy-Induced Neurotoxicity

Active, not recruiting

• Conditions: Neurotoxicity Syndromes
• Interventions: Other: Questionnaires; Procedure: Peripheral nervous system examination; Genetic: Whole Genome Sequence

• Registration Number: NCT02481336
• Lead Sponsor: National Cheng-Kung University Hospital

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-06-09
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-25
• Status Verified: 2022-04
• Last Update Submitted: 2022-10-03
• Last Update Posted: 2022-10-04
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer patients receiving chemotherapy	Peripheral nervous system examination	Stage I-IV ovarian cancer receiving chemotherapy Paclitaxel/Carboplatin Stage II-IV endometrial cancer receiving chemotherapy Paclitaxel/Carboplatin Stage III \& high risk stage II colorectal cancer receiving chemotherapy with mFOLFOX 1. Questionnaires 2. Peripheral nervous system examination 3. Whole Genome Sequence
Cancer patients receiving chemotherapy	Whole Genome Sequence	Stage I-IV ovarian cancer receiving chemotherapy Paclitaxel/Carboplatin Stage II-IV endometrial cancer receiving chemotherapy Paclitaxel/Carboplatin Stage III \& high risk stage II colorectal cancer receiving chemotherapy with mFOLFOX 1. Questionnaires 2. Peripheral nervous system examination 3. Whole Genome Sequence
Cancer patients receiving chemotherapy	Questionnaires	Stage I-IV ovarian cancer receiving chemotherapy Paclitaxel/Carboplatin Stage II-IV endometrial cancer receiving chemotherapy Paclitaxel/Carboplatin Stage III \& high risk stage II colorectal cancer receiving chemotherapy with mFOLFOX 1. Questionnaires 2. Peripheral nervous system examination 3. Whole Genome Sequence

Primary Outcome Measures

Name	Time	Method
Adverse events occurring after chemotherapy based on genomic profiling	up to 2 years after chemotherapy

Secondary Outcome Measures

Name	Time	Method
Relapse-free survival	up to 5 years after chemotherapy
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 quantitative sensory test (QST)	up to 2 years after chemotherapy
Change from Baseline in nerve excitability test (NET)	up to 2 years after chemotherapy
Change from Baseline in nerve conduction velocity (NCV)	up to 2 years after chemotherapy
Overall Survival	up to 5 years after chemotherapy

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan